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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00699998




Registration number
NCT00699998
Ethics application status
Date submitted
16/06/2008
Date registered
18/06/2008
Date last updated
7/05/2013

Titles & IDs
Public title
A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects
Scientific title
A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects With Unstable Angina/Non-ST-Elevation Myocardial Infarction Who Are Medically Managed
Secondary ID [1] 0 0
H7T-MC-TABY(b)
Secondary ID [2] 0 0
11058
Universal Trial Number (UTN)
Trial acronym
TRILOGY ACS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Clopidogrel
Treatment: Drugs - Prasugrel
Treatment: Drugs - Commercially-available Aspirin

Experimental: Prasugrel - Prasugrel and Low-dose Commercially-available Aspirin

Active Comparator: Clopidogrel - Clopidogrel and Low-Dose Commercially-available Aspirin


Treatment: Drugs: Clopidogrel
300 milligrams (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study

Treatment: Drugs: Prasugrel
30 milligrams (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight and age), oral, once daily as maintenance dose through end of study

Treatment: Drugs: Commercially-available Aspirin
Low-dose aspirin, oral, as prescribed by physician through end of study
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke
Timepoint [1] 0 0
Randomization through end of study (30-month visit)
Secondary outcome [1] 0 0
Percentage of Participants With a Composite Endpoint of CV Death and MI
Timepoint [1] 0 0
Randomization through end of study (30-month visit)
Secondary outcome [2] 0 0
Percentage of Participants With a Composite Endpoint of CV Death, MI, Stroke, or Re-hospitalization for Recurrent Unstable Angina (UA)
Timepoint [2] 0 0
Randomization through end of study (30-month visit)
Secondary outcome [3] 0 0
Percentage of Participants With a Composite Endpoint of All-cause Death, MI, or Stroke
Timepoint [3] 0 0
Randomization through end of study (30-month visit)
Secondary outcome [4] 0 0
Platelet Aggregation Measures
Timepoint [4] 0 0
Day 30 and 12 Months
Secondary outcome [5] 0 0
Biomarker Measurements of Inflammation/Hemodynamic Stress: Brain Natriuretic Peptide (BNP)
Timepoint [5] 0 0
Day 30 and 6 Months
Secondary outcome [6] 0 0
Biomarker Measurements of Inflammation/Hemodynamic Stress: C-Reactive Protein (CRP)
Timepoint [6] 0 0
Day 30 and Month 6
Secondary outcome [7] 0 0
Genotyping Related to Drug Metabolism
Timepoint [7] 0 0
Baseline
Secondary outcome [8] 0 0
Economic and Quality of Life Outcomes
Timepoint [8] 0 0
Baseline and follow-up (24 months)
Secondary outcome [9] 0 0
Summary of All Deaths
Timepoint [9] 0 0
Randomization through end of study (30-month visit)

Eligibility
Key inclusion criteria
Key

- Have had a Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) index
event within 10 days prior to randomization

- Had a medical management strategy decision made with reasonable certainty that neither
percutaneous coronary intervention (PCI) nor coronary artery bypass graft (CABG) is
planned for treatment of the index event

- Had at least 1 of 4 specified high-risk features at the time of the UA/NSTEMI event

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Decision for medical management greater than 72 hours after onset of index event
without commercial clopidogrel treatment within 72 hours following onset of the index
event.

- Insignificant coronary artery disease (CAD) on coronary angiography if performed for
Index Event (absence of greater than or equal to 30% stenosis in at least one native
vessel)

- Previous or planned PCI or CABG as treatment for the index event

- PCI/CABG within previous 30 days

- ST-segment elevation myocardial infarction (STEMI) as the index event

- Cardiogenic shock, Refractory ventricular arrhythmias, New York Heart Association
(NYHA) Class IV congestive heart failure (CHF) within the previous 24 hours

- History of ischemic or hemorrhagic stroke, transient ischemic attack (TIA),
Intracranial neoplasm, arteriovenous malformation, or aneurysm

- History of spontaneous gastrointestinal (GI) or non-GI bleeding requiring
hospitalization for treatment, unless definitive treatment has occurred and there is
low likelihood of recurrence

- Hemodialysis or peritoneal dialysis

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2012
Sample size
Target
Accrual to date
Final
9326
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS
Recruitment hospital [1] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Coffs Harbour
Recruitment hospital [2] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Lismore
Recruitment hospital [3] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Newcastle
Recruitment hospital [4] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Wollongong
Recruitment hospital [5] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Herston
Recruitment hospital [6] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Nambour
Recruitment hospital [7] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Redcliffe
Recruitment hospital [8] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Southport
Recruitment hospital [9] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Bedford Park
Recruitment hospital [10] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Elizabeth Vale
Recruitment hospital [11] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Hobart
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
2480 - Lismore
Recruitment postcode(s) [3] 0 0
2305 - Newcastle
Recruitment postcode(s) [4] 0 0
2500 - Wollongong
Recruitment postcode(s) [5] 0 0
4029 - Herston
Recruitment postcode(s) [6] 0 0
4560 - Nambour
Recruitment postcode(s) [7] 0 0
4020 - Redcliffe
Recruitment postcode(s) [8] 0 0
4215 - Southport
Recruitment postcode(s) [9] 0 0
5042 - Bedford Park
Recruitment postcode(s) [10] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [11] 0 0
7000 - Hobart
Recruitment outside Australia
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Alabama
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Missouri
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France
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France
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France
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Paris
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France
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France
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France
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France
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France
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France
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Germany
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Bad Nauheim
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Germany
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Darmstadt
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Germany
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Germany
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Frankfurt
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Germany
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Halle
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Germany
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Idar-Oberstein
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Germany
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Köln
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Germany
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Leipzig
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Germany
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Germany
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Mannheim
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Germany
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Germany
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Hungary
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Baja
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Hungary
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Bekescsaba
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Hungary
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Budapest
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Hungary
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Hungary
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Hungary
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Komarom
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Hungary
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Miskolc
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Hungary
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Satoraljaujhely
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Hungary
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Sopron
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Hungary
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Szekszard
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Hungary
State/province [219] 0 0
Zalaegerszeg
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India
State/province [220] 0 0
Ahmedabad
Country [221] 0 0
India
State/province [221] 0 0
Anand
Country [222] 0 0
India
State/province [222] 0 0
Aurangabad
Country [223] 0 0
India
State/province [223] 0 0
Bangalore
Country [224] 0 0
India
State/province [224] 0 0
Baramati
Country [225] 0 0
India
State/province [225] 0 0
Bikaner
Country [226] 0 0
India
State/province [226] 0 0
Calicut
Country [227] 0 0
India
State/province [227] 0 0
Chidambaram
Country [228] 0 0
India
State/province [228] 0 0
Cochin
Country [229] 0 0
India
State/province [229] 0 0
Coimbatore
Country [230] 0 0
India
State/province [230] 0 0
Ernakulam
Country [231] 0 0
India
State/province [231] 0 0
Guntur
Country [232] 0 0
India
State/province [232] 0 0
Gurgaon
Country [233] 0 0
India
State/province [233] 0 0
Hyderabaad
Country [234] 0 0
India
State/province [234] 0 0
Indore
Country [235] 0 0
India
State/province [235] 0 0
Jaipur
Country [236] 0 0
India
State/province [236] 0 0
Jalandhar
Country [237] 0 0
India
State/province [237] 0 0
Kolkata
Country [238] 0 0
India
State/province [238] 0 0
Kottayam
Country [239] 0 0
India
State/province [239] 0 0
Lucknow
Country [240] 0 0
India
State/province [240] 0 0
Madurai
Country [241] 0 0
India
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Mumbai
Country [242] 0 0
India
State/province [242] 0 0
Mysore
Country [243] 0 0
India
State/province [243] 0 0
Nagpur
Country [244] 0 0
India
State/province [244] 0 0
Nashik
Country [245] 0 0
India
State/province [245] 0 0
New Delhi
Country [246] 0 0
India
State/province [246] 0 0
Patiala
Country [247] 0 0
India
State/province [247] 0 0
Pune
Country [248] 0 0
India
State/province [248] 0 0
Saket
Country [249] 0 0
India
State/province [249] 0 0
Secunderabad
Country [250] 0 0
India
State/province [250] 0 0
Shivamogga
Country [251] 0 0
India
State/province [251] 0 0
Solapur
Country [252] 0 0
India
State/province [252] 0 0
Surat
Country [253] 0 0
India
State/province [253] 0 0
Thrissur
Country [254] 0 0
India
State/province [254] 0 0
Tirupati
Country [255] 0 0
India
State/province [255] 0 0
Trivandrum
Country [256] 0 0
India
State/province [256] 0 0
Vadodara
Country [257] 0 0
India
State/province [257] 0 0
Vijayawada
Country [258] 0 0
India
State/province [258] 0 0
Visakhapatnam
Country [259] 0 0
Ireland
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Dublin
Country [260] 0 0
Ireland
State/province [260] 0 0
Galway
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Israel
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Afula
Country [262] 0 0
Israel
State/province [262] 0 0
Ashkelon
Country [263] 0 0
Israel
State/province [263] 0 0
Beer Sheva
Country [264] 0 0
Israel
State/province [264] 0 0
Eilat
Country [265] 0 0
Israel
State/province [265] 0 0
Haifa
Country [266] 0 0
Israel
State/province [266] 0 0
Jerusalem
Country [267] 0 0
Israel
State/province [267] 0 0
Kfar Saba
Country [268] 0 0
Israel
State/province [268] 0 0
Nahariya
Country [269] 0 0
Israel
State/province [269] 0 0
Nazareth
Country [270] 0 0
Israel
State/province [270] 0 0
Rehovot
Country [271] 0 0
Israel
State/province [271] 0 0
Tel Aviv
Country [272] 0 0
Israel
State/province [272] 0 0
Tel Hashomer
Country [273] 0 0
Israel
State/province [273] 0 0
Tiberias
Country [274] 0 0
Israel
State/province [274] 0 0
Tzfat
Country [275] 0 0
Italy
State/province [275] 0 0
Albano Laziale
Country [276] 0 0
Italy
State/province [276] 0 0
Ascoli Piceno
Country [277] 0 0
Italy
State/province [277] 0 0
Bari
Country [278] 0 0
Italy
State/province [278] 0 0
Bergamo
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Italy
State/province [279] 0 0
Brescia
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Italy
State/province [280] 0 0
Caserta
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Italy
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Forli
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Italy
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Lecco
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Italy
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Legnago
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Italy
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Italy
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Italy
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Italy
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Italy
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Italy
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Reggio Emilia
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Italy
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Rimini
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Italy
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Rome
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Italy
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San Daniele Del Friuli
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Italy
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Santa Maria Capua Vetere
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Italy
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Saronno
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Italy
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Sorrento
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Italy
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Italy
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
State/province [303] 0 0
Gwangju
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Korea, Republic of
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Korea, Republic of
State/province [305] 0 0
Jeon Ju-City
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Korea, Republic of
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Jin-Ju-Si
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Korea, Republic of
State/province [307] 0 0
Seoul
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Korea, Republic of
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Malaysia
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Johor Bahru
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Malaysia
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Mexico
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Mexico
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Mexico
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Mexico
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Mexico
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Mexico
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Mexico
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Mexico
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Mexico
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Netherlands
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Netherlands
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Netherlands
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Netherlands
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Netherlands
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Netherlands
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Leiderdorp
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Netherlands
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Netherlands
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Netherlands
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Netherlands
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Cocle
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David
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Peru
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Philippines
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Cagayan De De Oro
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Philippines
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Country [365] 0 0
Philippines
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Philippines
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Iloilo City
Country [367] 0 0
Philippines
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Country [368] 0 0
Philippines
State/province [368] 0 0
Marikina City
Country [369] 0 0
Philippines
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Metro Manila
Country [370] 0 0
Philippines
State/province [370] 0 0
Pasig City
Country [371] 0 0
Philippines
State/province [371] 0 0
Quezon City
Country [372] 0 0
Poland
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Poland
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Elblag
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Poland
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Gdansk
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Poland
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Poland
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Poland
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Poland
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Poland
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Poland
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Poland
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Lublin
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Poland
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Poland
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Nowy Sacz
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Poland
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Olawa
Country [385] 0 0
Poland
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Piotrkow Trybunalski
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Poland
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Pulawy
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Poland
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Ruda Slaska
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Poland
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Poland
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Poland
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Poland
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Poland
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Wejherowo
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Poland
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Portugal
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Portugal
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Coimbra
Country [397] 0 0
Portugal
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Country [398] 0 0
Portugal
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Portugal
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Santarem
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Portugal
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Portugal
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Vila Franca De Xira
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Puerto Rico
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Puerto Rico
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Mayaguez
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Puerto Rico
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San Juan
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Romania
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Bacau
Country [406] 0 0
Romania
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Baia Mare
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Romania
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Braila
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Romania
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Brasov
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Romania
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Bucharest
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Romania
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Buzau
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Romania
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Cluj-Napoca
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Romania
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Focsani
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Romania
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Pitesti
Country [414] 0 0
Romania
State/province [414] 0 0
Suceava
Country [415] 0 0
Romania
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Targoviste
Country [416] 0 0
Russian Federation
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Arkhangelsk
Country [417] 0 0
Russian Federation
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Gatchina
Country [418] 0 0
Russian Federation
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Kazan
Country [419] 0 0
Russian Federation
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Kemerovo
Country [420] 0 0
Russian Federation
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Krasnoyarsk
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Russian Federation
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Moscow
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Russian Federation
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Nizhny Novgorod
Country [423] 0 0
Russian Federation
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Novokuznetsk
Country [424] 0 0
Russian Federation
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Novosibirsk
Country [425] 0 0
Russian Federation
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Omsk
Country [426] 0 0
Russian Federation
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Rostov-On-Don
Country [427] 0 0
Russian Federation
State/province [427] 0 0
Saint Petersburg
Country [428] 0 0
Russian Federation
State/province [428] 0 0
Saratov
Country [429] 0 0
Russian Federation
State/province [429] 0 0
Tomsk
Country [430] 0 0
Russian Federation
State/province [430] 0 0
Tyumen
Country [431] 0 0
Serbia
State/province [431] 0 0
Belgrade
Country [432] 0 0
Serbia
State/province [432] 0 0
Kragujevac
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Serbia
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Niska Banja
Country [434] 0 0
Serbia
State/province [434] 0 0
Nis
Country [435] 0 0
Serbia
State/province [435] 0 0
Zemun
Country [436] 0 0
Singapore
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Singapore
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Slovakia
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Bratislava
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Slovakia
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Levice
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Slovakia
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Martin
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Slovakia
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Nitra
Country [441] 0 0
Slovakia
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Nove Zamky
Country [442] 0 0
Slovakia
State/province [442] 0 0
Presov
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Slovakia
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Ruzomberok
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Slovakia
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Country [445] 0 0
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Alberton
Country [446] 0 0
South Africa
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Bloemfontein
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South Africa
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Cape Town
Country [448] 0 0
South Africa
State/province [448] 0 0
Durban
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South Africa
State/province [449] 0 0
George
Country [450] 0 0
South Africa
State/province [450] 0 0
Johannesburg
Country [451] 0 0
South Africa
State/province [451] 0 0
Parktown West
Country [452] 0 0
South Africa
State/province [452] 0 0
Somerset West
Country [453] 0 0
South Africa
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Worcester
Country [454] 0 0
Spain
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Barcelona
Country [455] 0 0
Spain
State/province [455] 0 0
Gerona
Country [456] 0 0
Spain
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Málaga
Country [457] 0 0
Spain
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Palma De Mallorca
Country [458] 0 0
Spain
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Reus
Country [459] 0 0
Spain
State/province [459] 0 0
San Boi De Llobregat
Country [460] 0 0
Spain
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Sevilla
Country [461] 0 0
Spain
State/province [461] 0 0
Valencia
Country [462] 0 0
Sweden
State/province [462] 0 0
Bollnas
Country [463] 0 0
Sweden
State/province [463] 0 0
Karlstad
Country [464] 0 0
Sweden
State/province [464] 0 0
Lund
Country [465] 0 0
Switzerland
State/province [465] 0 0
Bellinzona
Country [466] 0 0
Switzerland
State/province [466] 0 0
Winterthur
Country [467] 0 0
Taiwan
State/province [467] 0 0
Kaohsiung
Country [468] 0 0
Taiwan
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Sunderland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Daiichi Sankyo Co., Ltd.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Duke Clinical Research Institute
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the relative efficacy and safety of prasugrel and clopidogrel in a
medically managed Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) acute
coronary syndrome (ACS) population (that is, patients who are not managed with acute coronary
revascularization).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00699998
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/ct2/show/NCT00699998