A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects With Unstable Angina/Non-ST-Elevation Myocardial Infarction Who Are Medically Managed

ELI LILLY AND COMPANY,0 个研究点目标入组 156 人开始时间: 2008年11月28日最近更新: 2023年9月4日

试验速览

阶段: 未知
状态: 已完成
发起方
入组人数: 156

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 60 至 100（—）

入选标准

•Have had a UA / NSTEMI index event within 7 days (168 hours) before randomization (based on the diagnostic criteria for the disease included in Section 4.1.1).
•Have made a decision about the medical treatment strategy with reasonable certainty; that is, neither a PCI nor a CABG is planned for the treatment of the index event.
•Have had at least 1 of the following 3 characteristics that indicate high risk at the time of the UA / NSTEMI event: Age> 60 years, previous MI that is evidenced by pre-existing Q waves, or demonstration of infarction in the studies of imaging detection, or previous documentation of elevated cardiac markers, Diabetes mellitus, defined according to concomitant treatment with an oral hypoglycaemic agent and / or insulin.
•Have at least 1 stenosis in native coronary arteries> 50% (applies only to those subjects who undergo diagnostic coronary angiography within a period of 7 days from the start of the index event, but who do not undergo a PCI or a CABG after the angiography was performed).

排除标准

•Medical treatment decision> 24 hours after the start of the index event without treatment with commercial clopidogrel within 24 hours after the start of the index event (note: treatment with commercial clopidogrel should continue on a daily basis, hereinafter, until randomization).
•PCI or CABG previous or planned (during index hospitalization or hereafter) as treatment for the index event.
•PCI or CABG within the previous 30 days.
•STEMI as the index event.
•Cardiogenic shock within the previous 24 hours (defined as systolic blood pressure <90 mm Hg associated with clinical evidence of hypoperfusion of the target organ or hypotension that requires vasopressors to maintain systolic blood pressure above 90 mm Hg and associated with clinical evidence of hypoperfusion of the target organ).
•Ventricular arrhythmias refractory to treatment within the previous 24 hours.
•Symptoms of Congestive Heart Failure (CHF) Class IV according to the New York Heart Association (NYHA) within the previous 24 hours (see Annex TABY.4 for information on the NYHA CHF classifications).
•Have contraindications to receive antiplatelet therapy.
•Have received fibrinolytic therapy as initial treatment for the index event.
•Have a history of hemorrhagic diathesis.
•Associated clinical findings, in the opinion of the investigator, with an unacceptably high risk of bleeding.
•Existence of any of the following situations: history of hemorrhagic or ischemic stroke, intracranial neoplasia, arteriovenous malformation or aneurysm, history of any TIA symptom.
•International standardized index (INR) known> 1.5 at the time of selection.
•Platelet count <100,000 / mm3 at the time of selection.
•Anemia (hemoglobin [Hgb] <10 gm / dL) at the time of selection.
•History of spontaneous gastrointestinal bleeding that requires treatment in the hospital.
•History of spontaneous non-gastrointestinal internal bleeding that requires treatment in the hospital.
•Currently receiving hemodialysis or peritoneal dialysis
•History of intolerance or allergy to aspirin or approved thienopyridines (ticlopidine or clopidogrel).
•Receive treatment with ticlopidine within 5 days of randomization.
•Receive treatment with prasugrel at the time of selection.
•Receive anticoagulants orally at the time of selection or plan to receive anticoagulant therapy orally during the study.
•Receive daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (C0X2) inhibitors that can not be discontinued, or that the need for daily treatment for a period of> 2 weeks with NSAIDs or inhibitors is anticipated of C0X2 during the study.
•Not be willing to give written informed consent or not have enough mental conditions to do so.
•Personnel of the research center directly affiliated with the study or direct family of the personnel of the research center directly affiliated with the study. The spouse, parents, children or biological or legally adopted brothers are direct relatives.
•Staff employed by Eli Lilly and Company, Ube Industries Limited, Daiichi Sankyo Pharma Inc, academic research organization (ARO), or contract research organization (CRO) (ie, employees, temporary contract workers or designated responsible persons) of the realization of the study). Direct family members of Lilly employees may participate in clinical studies sponsored by Lilly, but are no

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发起方

ELI LILLY AND COMPANY,

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