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Trial registered on ANZCTR


Registration number
ACTRN12607000328471
Ethics application status
Approved
Date submitted
8/06/2007
Date registered
19/06/2007
Date last updated
24/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
THE IMPACT OF THREE DIFFERENT GLYCOPROTEIN PLATELET RECEPTOR IIb/IIIa ANTAGONISTS ON GLYCOPROTEIN IIb/IIIa PLATELET RECEPTOR INHIBITION AND CLINICAL ENDPOINTS IN PATIENTS WITH ACUTE CORONARY SYNDROMES
Scientific title
THE IMPACT OF THREE DIFFERENT GLYCOPROTEIN PLATELET RECEPTOR IIb/IIIa ANTAGONISTS ON GLYCOPROTEIN IIb/IIIa PLATELET RECEPTOR INHIBITION AND CLINICAL ENDPOINTS IN PATIENTS WITH ACUTE CORONARY SYNDROMES
Secondary ID [1] 287977 0
Nil known
Universal Trial Number (UTN)
Trial acronym
POTS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Assessing patients presenting with acute coronary syndromes, aiming to reduce adverse cardiac outcomes. 1877 0
Condition category
Condition code
Cardiovascular 1971 1971 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We aim to test patients stratified according to the operators usual practise of planned use or non use of glycoprotein IIb/IIIa antagonists. For those patients in whom the operator would normally choose to use a glycoprotein IIb/IIIa antagonists, patients will be randomized to receive high-dose bolus tirofiban, double bolus eptifibatide or abciximab. Our aim is to compare the effects of downstream high-dose bolus tirofiban, double bolus eptifibatide and abciximab on the degree of glycoprotein IIb/IIIa platelet receptor inhibition, tissue level perfusion and cardiac endpoints in high risk acute coronary syndrome patients treated with percutaneous coronary intervention. Furthermore, patients given ticagrelor and prasugrel versus clopidogrel at the physician's disgression were compared in terms of bleeding events. DOSAGE/DOSAGE FORM, ROUTE, AND DOSE REGIMEN: Where randomized patients will be receive high dose bolus tirofiban (IV loading infusion of tirofiban 25 µg/kg per 3 minutes followed by an infusion of 0.15 µg/kg/min for 12 hours), eptifibatide (IV bolus of 180 µg/kg + second bolus 10 mins after first of 180 µg/kg, simultaneously with first bolus infusion of 2.0 µg/kg/min for 12 hours) or abciximab (0.25mg/kg bolus followed by an infusion of 0.125 µg/kg/min {maximum 10 µg/min} for 12 hours). Initial bolus doses will be administered immediately prior to PCI.
Intervention code [1] 1814 0
Treatment: Drugs
Comparator / control treatment
Comparing three GPIs; abciximab, eptifibatide, and tirofiiban.
Control group
Active

Outcomes
Primary outcome [1] 2788 0
To assess the impact of differing glycoprotein IIb/IIIA inhibitors on degree of glycoprotein IIb/IIIa platelet receptor platelet inhibition during percutaneous coronary intervention (PCI).
Timepoint [1] 2788 0
Achievement of > 95% inhibition 10 minutes after the bolus dose is considered optimal.
Secondary outcome [1] 4707 0
Secondary; To assess impact of three different drug regimens on the combined incidence of: death, new myocardial infarction (MI), urgent target vessel revascularisation and rehospitalisation for acute coronary syndromes at 30 days.
Timepoint [1] 4707 0
30 days after randomisation
Secondary outcome [2] 4708 0
Tertiary: To assess the rate of bleeding and MACEs between patients given GPIs and co-administered P2Y12 (anti-platelet) agents.
Timepoint [2] 4708 0
30 days

Eligibility
Key inclusion criteria
A. Patients must:1. Subjects who had their most recent episode of anginal pain within the 7 days preceding randomization. 3. Be candidates for coronary angiography and revascularisation4. Provide written informed consentB. Patients must present to the hospital with anginal symptoms suggestive of cardiac ischaemia described by either of the following clinical presentations:1. Accelerating pattern of anginal pain (episodes of angina that are more frequent, severe, longer in duration, and/or precipitated by less exertion), or2. Prolonged (³20 minutes) or recurrent (³2 episodes lasting at least 5 minutes in the last 24 hours) anginal pain at rest or with minimal effortC. The symptoms of angina MUST also be associated with at least ONE of the conditions below [1) 2) or 3)]:1. ECG evidence of myocardial ischaemia manifested by:a) Transient (<20 minutes) ST-segment elevation ³0.1 mV (0.08 seconds after the J?point) in at least two leads, orb) Persistent or transient ST-segment depression =0.05 mV (0.08 seconds after the J-point) in at least two leads, not known to be old, and not in the setting of LVH orc) Persistent or transient T-wave inversion =0.3 mV (or pseudonormalization ³0.1 mV above the isoelectric line) in at least three leads not known to be old and not in the setting of LVH.d) ST segment elevation acute coronary syndrome undergoing primary PCIOR2. Abnormal cardiac enzymes defined as:a) CK-MB fraction within 7 days and subsequent to the last episode of chest pain, greater than the upper limit of normal, orb) Total CK =2 times the upper limit of normal (if CK-MB not available), orc) Troponin level greater than the upper limit of normal.OR3. Prior diagnosis of coronary disease as evidenced by:1) A documented MI or 2) Prior documented revascularisation with PTCA, directional coronary artherectomy (DCA), stent, or CABG, or 3) Prior angiography demonstrating at least one major coronary artery with a diameter stenosis = 50%.
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a. Known or suspected pregnancy.b. Thrombolytic therapy within the 48 hours prior to enrollment.c. Angina precipitated by obvious provoking factors (e.g., arrhythmia, infection, severe anemia, or hyperthyroidism).d. History or symptoms (e.g., pain radiating to the back) suggestive of aortic dissection.e. Patients with uncontrolled severe (resulting in haemodynamic instability) cardiac arrhythmias.f. Increased bleeding risk as follows: 1) Recent (<1 month) or active bleeding disorder including a history of gastrointestinal bleeding, hematuria (>10 RBC’s per high power field (hpf)), or presence of occult blood in the stool. Any patient with a known coagulopathy, platelet disorder, or history of thrombocytopenia will also be excluded. 2) Any confirmed persistent recording of systolic blood pressure exceeding 180 mm Hg and/or diastolic blood pressure exceeding 110 mm Hg at time of enrollment. 3) Any history of hemorrhagic cerebrovascular disease or active intracranial pathologic process. Any history of cerebrovascular disease (or transient ischaemic attack) within 1 year. 4) Traumatic or prolonged cardiopulmonary resuscitation within the 2 weeks prior to study enrollment. 5) Severe trauma within 3 months prior to study enrollment. 6) Major surgical procedure or any ophthalmologic surgery within 1 month prior to study enrollment. 7) Invasive procedure (or lithotripsy) within 14 days of enrollment that would significantly increase the risk of hemorrhage (such as organ biopsy). 8) Active peptic ulcer disease within the 3 months prior to study enrollment. 9) Suspected pericarditis.10) Presence of known significant retinopathy (i.e., hemorrhages, exudates, or neovascularization).g. Patients with acute pulmonary edema (rales present over more than 50% of the lung fields) or patients with severe congestive heart failure (New York Heart Association Functional Class III or IV). Patients with cardiogenic shock will also be excluded.h. Patients with hemodynamically significant valvular heart disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, or congenital heart disease.i. Patients with clinically important systemic renal, pulmonary, hepatic, endocrine (e.g., uncontrolled diabetes or uncontrolled thyroid disease), neurological, or hematological disorders. j. Patients with clinically important abnormal laboratory findings including:1. Serum creatinine >220 mmol/L.2. Hemoglobin <11 g/dL (<110 g/L) or hematocrit <34%.3. Platelet count <150,000/mm3 (<150 X 10 9/L).3. PT > 1.3 x control4. k. Treatment with abciximab within the past 96 hours.l. Patients with heparin allergy/intolerance.m. Patients currently on warfarin therapy.n. Patients with a history of cancer not known to be disease free, with the exception of basal cell carcinoma of the skin.o. Patients with any other medical condition, which, in the investigator's opinion, makes survival for the duration of the study unlikely, or would otherwise interfere with optimal participation in the study (i.e. substance abuse) or produce a significant risk to the patient.p. Inability to give informed consent.

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)
Allocation concealment-Allocation will be allocated according to sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation-via a randomisation table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
People assessing clinical outcomes will be blinded to treatment assignment, as will those performing data analysis
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2007
Actual
19/09/2007
Date of last participant enrolment
Anticipated
Actual
27/11/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
210
Accrual to date
Final
83
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 2111 0
Self funded/Unfunded
Name [1] 2111 0
Merck Sharp and Dohm Pty Ltd
Country [1] 2111 0
Australia
Primary sponsor type
Individual
Name
A/Professor Craig Juergens
Address
Elizabeth Street Liverpool NSW
Country
Australia
Secondary sponsor category [1] 1920 0
Individual
Name [1] 1920 0
Professor John French
Address [1] 1920 0
Elizabeth Street Liverpool NSW
Country [1] 1920 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3903 0
Sydney Southwest Area Health Service Human Research Ethics Committee (Western Zone)
Ethics committee address [1] 3903 0
Ethics committee country [1] 3903 0
Australia
Date submitted for ethics approval [1] 3903 0
Approval date [1] 3903 0
28/05/2007
Ethics approval number [1] 3903 0
2007/011

Summary
Brief summary
Our aim is to compare the effects of downstream high-dose bolus tirofiban, double bolus eptifibatide and abciximab on the degree of glycoprotein IIb/IIIa platelet receptor inhibition and cardiac endpoints in high risk acute coronary syndrome patients treated with percutaneous coronary intervention. We also aim to assess bleeding and MACEs in patients wtih GPI and co-administered P2Y12 antagonists.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27628 0
A/Prof Craig Juergens
Address 27628 0
Department of Cardiology Liverpool Hospital Elizabeth Street Liverpool NSW 2170
Country 27628 0
Australia
Phone 27628 0
+61 2 98283078
Fax 27628 0
Email 27628 0
C.Juergens@unsw.edu.au
Contact person for public queries
Name 11003 0
A/Prof Craig Juergens
Address 11003 0
Department of Cardiology
Liverpool Hospital
Elizabeth Street
Liverpool NSW 2170
Country 11003 0
Australia
Phone 11003 0
+61 2 98283078
Fax 11003 0
+61 2 98283054
Email 11003 0
C.Juergens@unsw.edu.au
Contact person for scientific queries
Name 1931 0
A/Prof Craig Juergens
Address 1931 0
Department of Cardiology
Liverpool Hospital
Elizabeth Street
Liverpool NSW 2170
Country 1931 0
Australia
Phone 1931 0
+61 2 98283078
Fax 1931 0
+61 2 98283054
Email 1931 0
C.Juergens@unsw.edu.au

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA randomized trial assessing the impact of three different glycoprotein IIb/IIIa antagonists on glycoprotein IIb/IIIa platelet receptor inhibition and clinical endpoints in patients with acute coronary syndromes.2016https://dx.doi.org/10.1111/1755-5922.12203
N.B. These documents automatically identified may not have been verified by the study sponsor.