EUCTR2007-005210-39-FR进行中（未招募）1 期
A 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 - Trilogy ACS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 11,200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Have had a UA/NSTEMI index event within 7 days (168 hours) prior to randomization (based on the disease diagnostic criteria in Section 4.1.1).
- •2. Have had a medical management strategy decision made with reasonable certainty; that is, neither PCI nor CABG is planned for treatment of the index event.
- •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 (as defined in Section 4.1.2).
- •3. 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.
- •4. 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
排除标准
- •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 end-organ 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). Immediate family of Lilly employees may participate in Lilly-sponsored clinical studies, but are not permitted to participate at a Lilly facility. Immediate family is d
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