CTRI/2009/091/000571已完成3 期
A prospective, randomised, double-blind, double dummy, comparative, parallel assignment, multicentric clinical trial to compare the safety and efficacy of Prasugrel vs. Clopidogrel in patients with moderate-to-high-risk Acute Coronary Syndromes who are to undergo Percutaneous Coronary Intervention (PCI).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 220
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
入选标准
- •Inclusion Criteria
- •Patients with Acute coronary syndrome (UA/ NSTEMI or STEMI) who are to undergo PCI
- •Males and Females ≥18 to ≤75 years
- •Patients with body weight ≥ 60 kg
- •Patients willing to adhere to the protocol requirements
- •Patients able to provide free, willing and written informed consent.
- •For women of childbearing potential only, test negative for pregnancy between ACS presentation and enrolment (based on a urine pregnancy test) and agree to use a reliable method of birth control during the study
排除标准
- •Exclusion Criteria
- •Cardiovascular exclusion criteria
- •Cardiogenic shock at the time of randomization
- •Refractory ventricular arrhythmias
- •New York Heart Association class IV congestive heart failure
- •Bleeding risk exclusion criteria
- •Active internal bleeding or history of bleeding diathesis
- •Clinical findings, in the judgment of the investigator, associated with an increased risk of bleeding
- •Any of the following:
- •History of diagnosed peptic ulcers/spontaneous GI bleeding
- •History of hemorrhagic stroke
- •Intracranial neoplasm, arteriovenous malformation, or aneurysm
- •History of ischemic stroke/transient ischemic attack (TIA)
- •Platelet count of less than 100000/mm3 at the time of screening
- •Anaemia (haemoglobin < 10 g/dL) at the time of screening
- •Prior/concomitant therapy exclusion criteria
- •One or more doses of a thienopyridine 5 days or less before PCI
- •Oral anticoagulation or other antiplatelet therapy that cannot be safely discontinued for the duration of the study other than aspirin
- •Daily treatment with nonsteroidal anti-inflammatory drugs or cyclooxygenase-2 inhibitors
- •General exclusion criteria
- •Treatment within the last 30 days with an investigational drug or are presently enrolled in another drug or device study
- •Previously completed or withdrawn from this study or any other study investigating prasugrel
- •Women who are known to be pregnant, have given birth within the past 90 days, or are breast-feeding
- •Concomitant medical illness that in the opinion of the investigator is associated with reduced survival over the expected treatment period
- •Patients with liver enzymes more than 2.5X the upper limit normal and/or serum biluribin more than 1.5X the upper limit normal
- •Any condition associated with poor treatment compliance, including alcoholism, mental illness, or drug dependence
- •Intolerance of or allergy to aspirin, ticlopidine, or clopidogrel
- •Unable to adhere to protocol requirements and follow-up procedures
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