Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome (ACS) Subjects with Unstable Angina/Non-ST-Elevation Myocardial Infarction UA/NSTEMI) Who are Medically Managed ? The TRILOGY ACS Study - H7T-MC-TABY(a)
- Conditions
- Treatment of Acute Coronay Syndrome in medically managed subjects enrolled within 7 days of the UA/NSTEMI index eventMedDRA version: 9.1Level: LLTClassification code 10051592Term: Acute coronary syndrome
- Registration Number
- EUCTR2007-005210-39-IT
- Lead Sponsor
- ELI LILLY
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 11200
- Male or female, 18 years of age or older who have had a UA/NSTEMI index event within 7 days (168hours) prior to randomization. - Have had a decision for medical management (that is, neither percutaneous coronary intervention [PCI] nor coronary artery bypass graft [CABG] is planned for management of the index event). This decision should be made with reasonable certainty and be based on angiography and/or the subject?s known clinical information (may include, but need not be limited to known coronary anatomy, age, or co-morbidity). For subjects whose medical management decision and randomization occurs no later than 24 hours following onset of the index event, prior clopidogrel treatment is not a consideration for eligibility. For subjects with a medical management decision who are randomized beyond 24 hours of onset of the index event, commercial clopidogrel must have been received according to standard of care practice guidelines no later than 24 hours following the onset of the index event . - Have had at least 1 of the following 3 high-risk features at the time of the UA/NSTEMI event: Age >60 years Prior MI evidenced by pre-existing Q waves, or demonstration of infarction on imaging studies, or prior documentation of elevated cardiac markers. Diabetes Mellitus - defined by concomitant treatment with an oral hypoglycemic agent and/or insulin. - Have at least 1 native coronary artery stenosis > 50% (applies only to those subjects who undergo diagnostic coronary angiography within 7 days of the onset of the index event but do not undergo PCI or CABG after angiography is performed
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Cardiovascular Exclusion Criteria
[5] Decision for medical management >24 hours after the onset of the
index event without commercial clopidogrel treatment within 24 hours
following the onset of the index event (Note: commercial clopidogrel
treatment must continue daily thereafter until randomization).
[6] Previous or planned (during the index hospitalization or thereafter)
PCI or CABG as treatment for the index event.
[7] PCI or CABG within the previous 30 days.
[8] STEMI as the index event.
[9] Cardiogenic shock within the previous 24 hours (defined as a systolic
blood pressure <90 mm Hg associated with clinical evidence of endorgan
hypoperfusion, or hypotension requiring vasopressors to
maintain systolic blood pressure over 90 mm Hg and associated with
clinical evidence of end-organ hypoperfusion).
[10] Refractory ventricular arrhythmias within the previous 24 hours.
[11] Symptoms of New York Heart Association (NYHA) Class IV
congestive heart failure (CHF) within the previous 24 hours (see
Attachment TABY.4 for NYHA CHF classifications).
Exclusion Criteria Related to Bleeding
[12] Contraindicated for antiplatelet therapy.
[13] Received fibrinolytic therapy as initial treatment for the index event.
[14] Any history of bleeding diathesis.
[15] Clinical findings associated, in the judgment of the investigator, with
an unacceptably high risk of bleeding.
[16] Any of the following:
History of ischemic or hemorrhagic stroke
Intracranial neoplasm, arteriovenous malformation, or aneurysm
History of any TIA symptoms.
[17] International Normalized Ratio (INR) known to be >1.5 at the time of
screening.
[18] Platelet count of <100,000/mm3 at the time of screening.
[19] Anemia (hemoglobin [Hgb] <10 gm/dL) at the time of screening.
[20] History of spontaneous gastrointestinal bleeding requiring in-hospital
treatment.
[21] History of spontaneous non-gastrointestinal internal bleeding requiring
in-hospital treatment.
[22] Currently receiving hemodialysis or peritoneal dialysis.
Prior/Concomitant Therapy Exclusion Criteria
[23] History of intolerance or allergy to aspirin or approved thienopyridines
(ticlopidine or clopidogrel).
[24] Treated with ticlopidine within 5 days of randomization.
[25] Receiving prasugrel treatment at the time of screening.
[26] Receiving oral anticoagulants at the time of screening or are
anticipated to require oral anticoagulants therapy during the course of
the study.
[27] Receiving daily treatment with nonsteroidal anti-inflammatory drugs
(NSAIDs) or cyclooxygenase-2 (COX2) inhibitors that cannot be
discontinued or are anticipated to require >2 weeks of daily treatment
with NSAIDs or COX2 inhibitors during the study.
General Exclusion Criteria
[28] Unwilling to provide or not sufficiently mentally competent to provide
written informed consent.
[29] Study site personnel directly affiliated with the study or are immediate
family of study site personnel directly affiliated with the study.
Immediate family is defined as a spouse, parent, child, or sibling,
whether biological or legally adopted.
[30] Employed by Eli Lilly and Company, Ube Industries Limited, Daiichi
Sankyo Pharma Inc, the academic research organization (ARO), or the
contract research organization (CRO) (that is, employees, temporary
contract workers, or designees responsible for the conduct of the
study).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method