NCT00325390已完成3 期
Double-Blind Parallel Comparison Study of SR25990C Versus Standard Therapy in Japan(Ticlopidine) in Patients With Acute Coronary Syndrome Without ST-Segment Elevation Who Are Planned for Percutaneous Coronary Intervention
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Incidence of effficacy and safety events
研究概览
简要总结
To evaluate the efficasy and safety of SR25990C(loading dose:300mg, maintenance dose:75mg/day) in comparison with the standard Japanese treatment(ticlopidine) in patients with acute coronary syndrome without ST-segment elevation and planned for percutaneous coronary intervention(including stenting).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged above 20, admitted to hospitals with symptoms suspected to represent an acute coronary syndrome defined as unstable angina or acute MI without ST segment elevation greater than 1 mm are eligible for the study if they meet the following criteria:
- •(1)Clinical history consistent with new onset or worsening pattern of characteristic ischemic chest pain occurring at rest or with minimal exercise (lasting longer than 5 minutes or requiring sublingual nitroglycerin for the relief of pain within 24 hours before registration).
- •(2)Patients who meet either of following criteria
- •ECG changes compatible with new ischemia [e.g. ST depression (at least 1 mm), T wave inversion (at least 2 mm), or hyperacute peaked T waves in 2 contiguous leads].
- •already elevated CK at least twice the upper limit of normal or CK-MB or Troponin I or T above the upper limit of normal or positive qualitative test for Troponin T.
- •(3)A percutaneous coronary intervention is planned within 96 hours after the first study drug administration
排除标准
- •A)Factors that affect participation in study:
- •(1)Previous disabling stroke
- •(2)Previous intracranial hemorrhage or hemorrhagic stroke
- •(3)Severe co-morbid condition such that the patient is not expected to survive 1 month
- •(4)NYHA Class IV heart failure
- •(5)Uncontrolled hypertension
- •(6)Requirement for use of oral anticoagulants, non study antiplatelet agents (including ticlopidine) or NSAIDs (excluding unum sumatur), during study period,
- •B)Factors related to ASA and/or ticlopidine treatment:
- •(1)Use of ticlopidine within 1 week prior to randomization
- •(2)History of ASA or ticlopidine intolerance or allergy
- •(3)Contraindications to ASA or ticlopidine
结局指标
主要结局
Incidence of effficacy and safety events
次要结局
- Incidence of efficacy or safety events, adverse events, adverse drug reactions and bleeding events ・
研究者
研究点 (1)
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