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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01000727




Registration number
NCT01000727
Ethics application status
Date submitted
22/10/2009
Date registered
23/10/2009

Titles & IDs
Public title
The Stabilization Of pLaques usIng Darapladib-Thrombolysis In Myocardial Infarction 52 Trial
Scientific title
A Clinical Outcomes Study of Darapladib Versus Placebo in Subjects Following Acute Coronary Syndrome to Compare the Incidence of Major Adverse Cardiovascular Events (MACE).
Secondary ID [1] 0 0
480848/033
Universal Trial Number (UTN)
Trial acronym
SOLID-TIMI 52
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 - Darapladib 160 mg
Treatment: Drugs - Placebo
Other interventions - Standard Therapy

Experimental: Darapladib 160 mg - Single daily oral tablet

Placebo comparator: Placebo - Single daily oral tablet


Treatment: Drugs: Darapladib 160 mg
Lp-PLA2 inhibitor

Treatment: Drugs: Placebo
Placebo administered

Other interventions: Standard Therapy
Guideline mandated therapy for individual's condition
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With First Occurrence of Any Event in the Composite of Major Coronary Events During the Time Period for Follow-up (FU) of Cardiovascular (CV) Event
Timepoint [1] 0 0
From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
Secondary outcome [1] 0 0
Number of Participants With First Occurrence of Any Component of the Composite of Major Adverse Cardiovascular Events (Cardiovascular [CV] Death, Non-fatal MI or Non-fatal Stroke) During the Time Period for Follow-up of CV Events
Timepoint [1] 0 0
From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
Secondary outcome [2] 0 0
Number of Participants With Cardiovascular Death During the Time Period for Follow-up of Cardiovascular Events
Timepoint [2] 0 0
From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
Secondary outcome [3] 0 0
Number of Participants With First Occurrence of MI (Fatal/Nonfatal) During the Time Period for Follow-up of Cardiovascular Events
Timepoint [3] 0 0
From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
Secondary outcome [4] 0 0
Number of Participants With First Occurrence of Stroke (Fatal/Non-fatal) During the Time Period for Follow-up of Cardiovascular Events
Timepoint [4] 0 0
From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
Secondary outcome [5] 0 0
Number of Participants With CHD Death During the Time Period for Follow-up of Cardiovascular Events
Timepoint [5] 0 0
From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
Secondary outcome [6] 0 0
Number of Participants With Urgent Coronary Revascularization for Myocardial Ischemia During the Time Period for Follow-up of Cardiovascular Events
Timepoint [6] 0 0
From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
Secondary outcome [7] 0 0
Number of Participants With First Occurrence of Any Event in the Composite of Total Coronary Events (CHD Death, Non-fatal MI, Hospitalization for Unstable Angina, or Any Coronary Revascularization Procedure) During the Time Period for FU of CV Events
Timepoint [7] 0 0
From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
Secondary outcome [8] 0 0
Number of Participants With First Occurrence of Any Coronary Revascularization Procedures (Excluding Coronary Revascularization Planned Prior to Randomization, But Performed After Randomization) During the Time Period for Follow-up of Cardiovascular Event
Timepoint [8] 0 0
From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
Secondary outcome [9] 0 0
Number of Participants With First Occurrence of Any Component of the Composite of All-cause Mortality, Non-fatal MI, or Nonfatal Stroke During the Time Period for Follow-up of Cardiovascular Events
Timepoint [9] 0 0
From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
Secondary outcome [10] 0 0
Number of Participants With First Occurrence of Any Event in the Composite of CHD Death and Non-fatal MI During the Time Period for Follow-up of Cardiovascular Events
Timepoint [10] 0 0
From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
Secondary outcome [11] 0 0
Number of Participants With All-cause Mortality During the Time Period for Vital Status
Timepoint [11] 0 0
From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)

Eligibility
Key inclusion criteria
* Signed written informed consent.
* Men or women at least 18 years old (in Taiwan, at least 20 years old). Women must be post-menopausal or using a highly effective method for avoidance of pregnancy.
* Hospitalization for acute coronary syndrome (ACS) within 30 days prior to study entry.
* Clinically stable for 24 hours prior to study entry.
* A planned percutaneous coronary intervention (PCI) should be performed prior to study entry, whenever possible.
* At least one of the following:
* At least 60 years old.
* Myocardial infarction prior to the qualifying ACS event.
* Diabetes mellitus requiring treatment with medication.
* Diagnosed mild or moderate reduction in kidney function.
* Cerebrovascular disease (carotid artery disease or ischemic stroke more than 3 months prior to study entry) OR peripheral artery disease.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* ACS symptoms or lab results not believed to be caused by a narrowing or blocked coronary artery.
* No major coronary artery with a blockage of more than 50% (unless all stenoses are successfully treated by PCI).
* Planned coronary artery bypass graft (CABG) surgery, or CABG surgery performed after the qualifying ACS event and prior to study entry.
* Certain types of liver disease.
* Severe reduction in kidney function OR removal of a kidney OR kidney transplant.
* Severe heart failure.
* Blood pressure higher than normal despite lifestyle changes and treatment with medications.
* Any life-threatening disease with a life expectancy of less than 2 years (other than heart disease) that may prevent the subject from completing the study.
* Severe asthma that is poorly controlled with medication.
* Pregnancy (Note: A pregnancy test will be performed on all non-sterile women prior to study entry).
* Previous severe allergic reaction to food, medications, drink, insect stings, etc.
* Drug or alcohol abuse within the past 6 months. Mental/psychological impairment that may prevent the subject from complying with study procedures or understanding the goal and potential risks of participating in the study.
* Certain medications that may interfere with the study medication (these will be identified by the study doctor).
* If both birth parents are at least 50% Japanese, Chinese, or Korean ancestry, must have a blood sample collected for Lp-PLA2 activity. Those with Lp-PLA2 activity less than or equal to 20.0 nmol/min/mL are excluded.
* Previously took darapladib (SB-480848).
* Participation in a study of an investigational medication within the past 30 days.
* Current participation in a study of an investigational device.
* Any other reason the investigator deems the subject should not participate in the study.

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
1/12/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/04/2014
Sample size
Target
Accrual to date
Final
13026
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Garran
Recruitment hospital [2] 0 0
GSK Investigational Site - Camperdown
Recruitment hospital [3] 0 0
GSK Investigational Site - Gosford
Recruitment hospital [4] 0 0
GSK Investigational Site - Auchenflower
Recruitment hospital [5] 0 0
GSK Investigational Site - Herston
Recruitment hospital [6] 0 0
GSK Investigational Site - Milton
Recruitment hospital [7] 0 0
GSK Investigational Site - Adelaide
Recruitment hospital [8] 0 0
GSK Investigational Site - Elizabeth Vale
Recruitment hospital [9] 0 0
GSK Investigational Site - Hobart
Recruitment hospital [10] 0 0
GSK Investigational Site - Box Hill
Recruitment hospital [11] 0 0
GSK Investigational Site - Nedlands
Recruitment hospital [12] 0 0
GSK Investigational Site - Fremantle
Recruitment hospital [13] 0 0
GSK Investigational Site - Ashford
Recruitment postcode(s) [1] 0 0
2606 - Garran
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
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2250 - Gosford
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4066 - Auchenflower
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4029 - Herston
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4064 - Milton
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5000 - Adelaide
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5112 - Elizabeth Vale
Recruitment postcode(s) [9] 0 0
7000 - Hobart
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3128 - Box Hill
Recruitment postcode(s) [11] 0 0
6009 - Nedlands
Recruitment postcode(s) [12] 0 0
6160 - Fremantle
Recruitment postcode(s) [13] 0 0
5035 - Ashford
Recruitment outside Australia
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Valenciennes
Country [177] 0 0
Germany
State/province [177] 0 0
Baden-Wuerttemberg
Country [178] 0 0
Germany
State/province [178] 0 0
Bayern
Country [179] 0 0
Germany
State/province [179] 0 0
Hessen
Country [180] 0 0
Germany
State/province [180] 0 0
Niedersachsen
Country [181] 0 0
Germany
State/province [181] 0 0
Nordrhein-Westfalen
Country [182] 0 0
Germany
State/province [182] 0 0
Rheinland-Pfalz
Country [183] 0 0
Germany
State/province [183] 0 0
Saarland
Country [184] 0 0
Germany
State/province [184] 0 0
Schleswig-Holstein
Country [185] 0 0
Germany
State/province [185] 0 0
Thueringen
Country [186] 0 0
Germany
State/province [186] 0 0
Berlin
Country [187] 0 0
Germany
State/province [187] 0 0
Bremen
Country [188] 0 0
Germany
State/province [188] 0 0
Halle
Country [189] 0 0
Germany
State/province [189] 0 0
Hamburg
Country [190] 0 0
Hungary
State/province [190] 0 0
Budapest
Country [191] 0 0
Hungary
State/province [191] 0 0
Cegléd
Country [192] 0 0
Hungary
State/province [192] 0 0
Eger
Country [193] 0 0
Hungary
State/province [193] 0 0
Gyula
Country [194] 0 0
Hungary
State/province [194] 0 0
Hodmezovasarhely
Country [195] 0 0
Hungary
State/province [195] 0 0
Kistarcsa
Country [196] 0 0
Hungary
State/province [196] 0 0
Miskolc
Country [197] 0 0
Hungary
State/province [197] 0 0
Szolnok
Country [198] 0 0
Hungary
State/province [198] 0 0
Szombathely
Country [199] 0 0
Hungary
State/province [199] 0 0
Székesfehérvár
Country [200] 0 0
Hungary
State/province [200] 0 0
Zalaegerszeg
Country [201] 0 0
India
State/province [201] 0 0
Ahmedabad
Country [202] 0 0
India
State/province [202] 0 0
Amritsar
Country [203] 0 0
India
State/province [203] 0 0
Chennai
Country [204] 0 0
India
State/province [204] 0 0
Faridabad
Country [205] 0 0
India
State/province [205] 0 0
Gandhinagar
Country [206] 0 0
India
State/province [206] 0 0
Gurgaon
Country [207] 0 0
India
State/province [207] 0 0
Hyderabad
Country [208] 0 0
India
State/province [208] 0 0
Indore
Country [209] 0 0
India
State/province [209] 0 0
Jaipur
Country [210] 0 0
India
State/province [210] 0 0
Lucknow
Country [211] 0 0
India
State/province [211] 0 0
Mohali
Country [212] 0 0
India
State/province [212] 0 0
New Delhi
Country [213] 0 0
India
State/province [213] 0 0
Noida
Country [214] 0 0
India
State/province [214] 0 0
Patiala
Country [215] 0 0
India
State/province [215] 0 0
Pune,
Country [216] 0 0
India
State/province [216] 0 0
Pune
Country [217] 0 0
India
State/province [217] 0 0
Secunderabad,
Country [218] 0 0
India
State/province [218] 0 0
Vadodara
Country [219] 0 0
India
State/province [219] 0 0
Visakhapatnam
Country [220] 0 0
Israel
State/province [220] 0 0
Ashkelon
Country [221] 0 0
Israel
State/province [221] 0 0
Beer Sheva
Country [222] 0 0
Israel
State/province [222] 0 0
Haddera
Country [223] 0 0
Israel
State/province [223] 0 0
Haifa
Country [224] 0 0
Israel
State/province [224] 0 0
Holon
Country [225] 0 0
Israel
State/province [225] 0 0
Jerusalem
Country [226] 0 0
Israel
State/province [226] 0 0
Kfar Saba
Country [227] 0 0
Israel
State/province [227] 0 0
Nahariya
Country [228] 0 0
Israel
State/province [228] 0 0
Poriya
Country [229] 0 0
Israel
State/province [229] 0 0
Raanana
Country [230] 0 0
Israel
State/province [230] 0 0
Ramat-Gan
Country [231] 0 0
Israel
State/province [231] 0 0
Rehovot
Country [232] 0 0
Israel
State/province [232] 0 0
Safed
Country [233] 0 0
Israel
State/province [233] 0 0
Tel Aviv
Country [234] 0 0
Italy
State/province [234] 0 0
Calabria
Country [235] 0 0
Italy
State/province [235] 0 0
Campania
Country [236] 0 0
Italy
State/province [236] 0 0
Emilia-Romagna
Country [237] 0 0
Italy
State/province [237] 0 0
Friuli-Venezia-Giulia
Country [238] 0 0
Italy
State/province [238] 0 0
Lazio
Country [239] 0 0
Italy
State/province [239] 0 0
Lombardia
Country [240] 0 0
Italy
State/province [240] 0 0
Marche
Country [241] 0 0
Italy
State/province [241] 0 0
Piemonte
Country [242] 0 0
Italy
State/province [242] 0 0
Sardegna
Country [243] 0 0
Italy
State/province [243] 0 0
Toscana
Country [244] 0 0
Italy
State/province [244] 0 0
Veneto
Country [245] 0 0
Italy
State/province [245] 0 0
Legnano
Country [246] 0 0
Italy
State/province [246] 0 0
Sassuolo
Country [247] 0 0
Japan
State/province [247] 0 0
Chiba
Country [248] 0 0
Japan
State/province [248] 0 0
Fukuoka
Country [249] 0 0
Japan
State/province [249] 0 0
Hokkaido
Country [250] 0 0
Japan
State/province [250] 0 0
Hyogo
Country [251] 0 0
Japan
State/province [251] 0 0
Kanagawa
Country [252] 0 0
Japan
State/province [252] 0 0
Kyoto
Country [253] 0 0
Japan
State/province [253] 0 0
Nagasaki
Country [254] 0 0
Japan
State/province [254] 0 0
Oita
Country [255] 0 0
Japan
State/province [255] 0 0
Okayama
Country [256] 0 0
Japan
State/province [256] 0 0
Osaka
Country [257] 0 0
Japan
State/province [257] 0 0
Saga
Country [258] 0 0
Japan
State/province [258] 0 0
Shizuoka
Country [259] 0 0
Japan
State/province [259] 0 0
Tokyo
Country [260] 0 0
Korea, Republic of
State/province [260] 0 0
Dae-Gu
Country [261] 0 0
Korea, Republic of
State/province [261] 0 0
Daejeon
Country [262] 0 0
Korea, Republic of
State/province [262] 0 0
Gangnam-gu, Seoul
Country [263] 0 0
Korea, Republic of
State/province [263] 0 0
Gwangju
Country [264] 0 0
Korea, Republic of
State/province [264] 0 0
Kangwon-do
Country [265] 0 0
Korea, Republic of
State/province [265] 0 0
Pusan
Country [266] 0 0
Korea, Republic of
State/province [266] 0 0
Seoul
Country [267] 0 0
Netherlands
State/province [267] 0 0
's-Hertogenbosch
Country [268] 0 0
Netherlands
State/province [268] 0 0
Amersfoort
Country [269] 0 0
Netherlands
State/province [269] 0 0
Amsterdam
Country [270] 0 0
Netherlands
State/province [270] 0 0
Apeldoorn
Country [271] 0 0
Netherlands
State/province [271] 0 0
Blaricum
Country [272] 0 0
Netherlands
State/province [272] 0 0
Den Haag
Country [273] 0 0
Netherlands
State/province [273] 0 0
Deventer
Country [274] 0 0
Netherlands
State/province [274] 0 0
Dirksland
Country [275] 0 0
Netherlands
State/province [275] 0 0
Doetinchem
Country [276] 0 0
Netherlands
State/province [276] 0 0
Drachten
Country [277] 0 0
Netherlands
State/province [277] 0 0
Eindhoven
Country [278] 0 0
Netherlands
State/province [278] 0 0
Gorinchem
Country [279] 0 0
Netherlands
State/province [279] 0 0
Gouda
Country [280] 0 0
Netherlands
State/province [280] 0 0
Groningen
Country [281] 0 0
Netherlands
State/province [281] 0 0
Hardenberg
Country [282] 0 0
Netherlands
State/province [282] 0 0
Harderwijk
Country [283] 0 0
Netherlands
State/province [283] 0 0
Heerenveen
Country [284] 0 0
Netherlands
State/province [284] 0 0
Heerlen
Country [285] 0 0
Netherlands
State/province [285] 0 0
Helmond
Country [286] 0 0
Netherlands
State/province [286] 0 0
Hilversum
Country [287] 0 0
Netherlands
State/province [287] 0 0
Hoofddorp
Country [288] 0 0
Netherlands
State/province [288] 0 0
Hoorn
Country [289] 0 0
Netherlands
State/province [289] 0 0
Nijmegen
Country [290] 0 0
Netherlands
State/province [290] 0 0
OSS
Country [291] 0 0
Netherlands
State/province [291] 0 0
Roermond
Country [292] 0 0
Netherlands
State/province [292] 0 0
Rotterdam
Country [293] 0 0
Netherlands
State/province [293] 0 0
Sittard-geleen
Country [294] 0 0
Netherlands
State/province [294] 0 0
Sneek
Country [295] 0 0
Netherlands
State/province [295] 0 0
Tiel
Country [296] 0 0
Netherlands
State/province [296] 0 0
Tilburg
Country [297] 0 0
Netherlands
State/province [297] 0 0
Veldhoven
Country [298] 0 0
Netherlands
State/province [298] 0 0
Venlo
Country [299] 0 0
Netherlands
State/province [299] 0 0
Zoetermeer
Country [300] 0 0
New Zealand
State/province [300] 0 0
Auckland
Country [301] 0 0
New Zealand
State/province [301] 0 0
Christchurch
Country [302] 0 0
New Zealand
State/province [302] 0 0
Dunedin
Country [303] 0 0
New Zealand
State/province [303] 0 0
Hamilton
Country [304] 0 0
New Zealand
State/province [304] 0 0
Lower Hutt
Country [305] 0 0
New Zealand
State/province [305] 0 0
New Plymouth
Country [306] 0 0
New Zealand
State/province [306] 0 0
Palmerston North
Country [307] 0 0
New Zealand
State/province [307] 0 0
Takapuna, Auckland
Country [308] 0 0
New Zealand
State/province [308] 0 0
Tauranga
Country [309] 0 0
New Zealand
State/province [309] 0 0
Whangarei
Country [310] 0 0
Peru
State/province [310] 0 0
Lima
Country [311] 0 0
Peru
State/province [311] 0 0
Callao
Country [312] 0 0
Peru
State/province [312] 0 0
Lima Cercado
Country [313] 0 0
Philippines
State/province [313] 0 0
Cebu City
Country [314] 0 0
Philippines
State/province [314] 0 0
Davao
Country [315] 0 0
Philippines
State/province [315] 0 0
Manila
Country [316] 0 0
Philippines
State/province [316] 0 0
Quezon City
Country [317] 0 0
Poland
State/province [317] 0 0
Bialystok
Country [318] 0 0
Poland
State/province [318] 0 0
Bydgoszcz
Country [319] 0 0
Poland
State/province [319] 0 0
Bytom
Country [320] 0 0
Poland
State/province [320] 0 0
Chrzanow
Country [321] 0 0
Poland
State/province [321] 0 0
Gdansk
Country [322] 0 0
Poland
State/province [322] 0 0
Gdynia
Country [323] 0 0
Poland
State/province [323] 0 0
Inowroclaw
Country [324] 0 0
Poland
State/province [324] 0 0
Krakow
Country [325] 0 0
Poland
State/province [325] 0 0
Lodz
Country [326] 0 0
Poland
State/province [326] 0 0
Lubin
Country [327] 0 0
Poland
State/province [327] 0 0
Mielec
Country [328] 0 0
Poland
State/province [328] 0 0
Olawa
Country [329] 0 0
Poland
State/province [329] 0 0
Opole
Country [330] 0 0
Poland
State/province [330] 0 0
Radom
Country [331] 0 0
Poland
State/province [331] 0 0
Skierniewice
Country [332] 0 0
Poland
State/province [332] 0 0
Tarnow
Country [333] 0 0
Poland
State/province [333] 0 0
Torun
Country [334] 0 0
Poland
State/province [334] 0 0
Tychy
Country [335] 0 0
Poland
State/province [335] 0 0
Walbrzych
Country [336] 0 0
Poland
State/province [336] 0 0
Warsaw
Country [337] 0 0
Poland
State/province [337] 0 0
Warszawa
Country [338] 0 0
Poland
State/province [338] 0 0
Wloclawek
Country [339] 0 0
Poland
State/province [339] 0 0
Wroclaw
Country [340] 0 0
Poland
State/province [340] 0 0
Zamosc
Country [341] 0 0
Poland
State/province [341] 0 0
Zielona Gora
Country [342] 0 0
Romania
State/province [342] 0 0
Baia Mare
Country [343] 0 0
Romania
State/province [343] 0 0
Braila
Country [344] 0 0
Romania
State/province [344] 0 0
Brasov
Country [345] 0 0
Romania
State/province [345] 0 0
Bucharest
Country [346] 0 0
Romania
State/province [346] 0 0
Cluj-Napoca
Country [347] 0 0
Romania
State/province [347] 0 0
Constanta
Country [348] 0 0
Romania
State/province [348] 0 0
Craiova
Country [349] 0 0
Romania
State/province [349] 0 0
Iasi
Country [350] 0 0
Romania
State/province [350] 0 0
Targu Mures
Country [351] 0 0
Russian Federation
State/province [351] 0 0
Barnaul
Country [352] 0 0
Russian Federation
State/province [352] 0 0
Ekaterinburg
Country [353] 0 0
Russian Federation
State/province [353] 0 0
Gatchina
Country [354] 0 0
Russian Federation
State/province [354] 0 0
Kemerovo
Country [355] 0 0
Russian Federation
State/province [355] 0 0
Krasnoyarsk
Country [356] 0 0
Russian Federation
State/province [356] 0 0
Moscow
Country [357] 0 0
Russian Federation
State/province [357] 0 0
Nizhniy Novgorod
Country [358] 0 0
Russian Federation
State/province [358] 0 0
Novosibirsk
Country [359] 0 0
Russian Federation
State/province [359] 0 0
Orenburg
Country [360] 0 0
Russian Federation
State/province [360] 0 0
Samara
Country [361] 0 0
Russian Federation
State/province [361] 0 0
Saratov
Country [362] 0 0
Russian Federation
State/province [362] 0 0
St'Petersburg
Country [363] 0 0
Russian Federation
State/province [363] 0 0
St-Petersburg
Country [364] 0 0
Russian Federation
State/province [364] 0 0
St. Petersburg
Country [365] 0 0
Russian Federation
State/province [365] 0 0
Tomsk
Country [366] 0 0
Russian Federation
State/province [366] 0 0
Tyumen
Country [367] 0 0
Russian Federation
State/province [367] 0 0
Yaroslavl
Country [368] 0 0
Slovakia
State/province [368] 0 0
Bratislava
Country [369] 0 0
Slovakia
State/province [369] 0 0
Kosice
Country [370] 0 0
Slovakia
State/province [370] 0 0
Nitra
Country [371] 0 0
Slovakia
State/province [371] 0 0
Nove Zamky
Country [372] 0 0
South Africa
State/province [372] 0 0
Free State
Country [373] 0 0
South Africa
State/province [373] 0 0
Gauteng
Country [374] 0 0
South Africa
State/province [374] 0 0
KwaZulu- Natal
Country [375] 0 0
South Africa
State/province [375] 0 0
Western Province
Country [376] 0 0
South Africa
State/province [376] 0 0
Goodwood
Country [377] 0 0
South Africa
State/province [377] 0 0
Kempton Park
Country [378] 0 0
South Africa
State/province [378] 0 0
Paarl
Country [379] 0 0
South Africa
State/province [379] 0 0
Parktown West
Country [380] 0 0
South Africa
State/province [380] 0 0
Parow
Country [381] 0 0
South Africa
State/province [381] 0 0
Pretoria
Country [382] 0 0
South Africa
State/province [382] 0 0
Somerset West
Country [383] 0 0
South Africa
State/province [383] 0 0
Worcester
Country [384] 0 0
Spain
State/province [384] 0 0
Alicante
Country [385] 0 0
Spain
State/province [385] 0 0
Barcelona
Country [386] 0 0
Spain
State/province [386] 0 0
Lerida
Country [387] 0 0
Spain
State/province [387] 0 0
León
Country [388] 0 0
Spain
State/province [388] 0 0
Madrid
Country [389] 0 0
Spain
State/province [389] 0 0
Malaga
Country [390] 0 0
Spain
State/province [390] 0 0
Oviedo
Country [391] 0 0
Spain
State/province [391] 0 0
San Juan/Alicante
Country [392] 0 0
Spain
State/province [392] 0 0
San Sebastián de los Reyes/Madrid
Country [393] 0 0
Spain
State/province [393] 0 0
San Sebastián
Country [394] 0 0
Spain
State/province [394] 0 0
Sevilla
Country [395] 0 0
Spain
State/province [395] 0 0
Valencia
Country [396] 0 0
Spain
State/province [396] 0 0
Vigo/Pontevedra
Country [397] 0 0
Sweden
State/province [397] 0 0
Göteborg
Country [398] 0 0
Sweden
State/province [398] 0 0
Hässleholm
Country [399] 0 0
Sweden
State/province [399] 0 0
Jönköping
Country [400] 0 0
Sweden
State/province [400] 0 0
Stockholm
Country [401] 0 0
Sweden
State/province [401] 0 0
Västerås
Country [402] 0 0
Sweden
State/province [402] 0 0
Örebro
Country [403] 0 0
Sweden
State/province [403] 0 0
Östersund
Country [404] 0 0
Taiwan
State/province [404] 0 0
Kaohsiung City
Country [405] 0 0
Taiwan
State/province [405] 0 0
Kaohsiung
Country [406] 0 0
Taiwan
State/province [406] 0 0
Taipei
Country [407] 0 0
Taiwan
State/province [407] 0 0
Yung Kang City
Country [408] 0 0
Thailand
State/province [408] 0 0
Bangkoknoi
Country [409] 0 0
Thailand
State/province [409] 0 0
Bangkok
Country [410] 0 0
Thailand
State/province [410] 0 0
Chiangmai
Country [411] 0 0
Thailand
State/province [411] 0 0
Khon Kaen, Muang
Country [412] 0 0
Thailand
State/province [412] 0 0
Nakhon Ratchasima
Country [413] 0 0
Thailand
State/province [413] 0 0
Pathumthani
Country [414] 0 0
Turkey
State/province [414] 0 0
Ankara
Country [415] 0 0
Turkey
State/province [415] 0 0
Erzurum
Country [416] 0 0
Turkey
State/province [416] 0 0
Eskisehir
Country [417] 0 0
Turkey
State/province [417] 0 0
Izmir
Country [418] 0 0
Ukraine
State/province [418] 0 0
Dnipropetrovsk
Country [419] 0 0
Ukraine
State/province [419] 0 0
Donetsk
Country [420] 0 0
Ukraine
State/province [420] 0 0
Kharkiv
Country [421] 0 0
Ukraine
State/province [421] 0 0
Kyiv
Country [422] 0 0
Ukraine
State/province [422] 0 0
Lugansk
Country [423] 0 0
Ukraine
State/province [423] 0 0
Lutsk
Country [424] 0 0
Ukraine
State/province [424] 0 0
Mykolaiv
Country [425] 0 0
Ukraine
State/province [425] 0 0
Odesa
Country [426] 0 0
Ukraine
State/province [426] 0 0
Simferopol
Country [427] 0 0
Ukraine
State/province [427] 0 0
Vinnytsia
Country [428] 0 0
Ukraine
State/province [428] 0 0
Zaporizhzhya
Country [429] 0 0
United Kingdom
State/province [429] 0 0
Devon
Country [430] 0 0
United Kingdom
State/province [430] 0 0
Lanarkshire
Country [431] 0 0
United Kingdom
State/province [431] 0 0
Middlesex
Country [432] 0 0
United Kingdom
State/province [432] 0 0
Northamptonshire
Country [433] 0 0
United Kingdom
State/province [433] 0 0
Nottinghamshire
Country [434] 0 0
United Kingdom
State/province [434] 0 0
Surrey
Country [435] 0 0
United Kingdom
State/province [435] 0 0
West Midlands
Country [436] 0 0
United Kingdom
State/province [436] 0 0
Antrim
Country [437] 0 0
United Kingdom
State/province [437] 0 0
Chichester
Country [438] 0 0
United Kingdom
State/province [438] 0 0
East Kilbride
Country [439] 0 0
United Kingdom
State/province [439] 0 0
Hertfordshire
Country [440] 0 0
United Kingdom
State/province [440] 0 0
Liverpool
Country [441] 0 0
United Kingdom
State/province [441] 0 0
Paisley
Country [442] 0 0
United Kingdom
State/province [442] 0 0
Stirling

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The TIMI Study Group
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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/study/NCT01000727