NCT01944800已完成4 期
Prospective, Randomized Trial of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome - Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment (ISAR-REACT) 5
Deutsches Herzzentrum Muenchen19 个研究点 分布在 2 个国家目标入组 4,018 人开始时间: 2013年9月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4,018
- 试验地点
- 19
- 主要终点
- Composite of death, myocardial infarction or stroke
研究概览
简要总结
Aim of the randomized, open-label, multicenter ISAR-REACT 5 trial is to assess whether ticagrelor is superior to prasugrel in patients with acute coronary syndrome and planned invasive strategy in terms of clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalization for an acute coronary syndrome (ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction or unstable angina pectoris) with planned invasive strategy
排除标准
- •intolerance of or allergy to ticagrelor or prasugrel
- •history of any stroke, transient ischemic attack or intracranial bleeding
- •known intracranial neoplasm, intracranial arteriovenous malformation or intracranial aneurysm
- •active bleeding, clinical findings, that in the judgement of the investigator are associated with an increased risk of bleeding
- •fibrin-specific fibrinolytic therapy less than 24 h before randomization, non-fibrin-specific fibrinolytic therapy less than 48 h before randomization
- •known platelet count < 100.000/μL at the time of screening
- •known anemia (hemoglobin <10 g/dL) at the time of screening
- •oral anticoagulation that cannot be safely discontinued for the duration of the study
- •INR known to be greater than 1.5 at the time of screening
- •chronic renal insufficiency requiring dialysis
- •moderate or severe hepatic dysfunction (Child Pugh B or C)
- •increased risk of bradycardia events (Sick Sinus, AV block grade II or III, bradycardia-induced syncope)
- •index event is an acute complication (< 30 days) of PCI
- •concomitant medical illness that in the opinion of the investigator is associated with a life expectancy < 1 year
- •concomitant oral or i.v. therapy with strong CYP3A Inhibitors (e.g. ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, grapefruit juice > 1 L/d), CYP3A substrates with narrow therapeutic indices (e.g. cyclosporine, quinidine), or strong CYP3A inducers (e.g. rifampin/rifampicin, phenytoin, carbamazepine, dexamethason, phenobarbital ) that cannot be safely discontinued
- •≥1 doses of ticagrelor or prasugrel within 5 days before randomisation
- •no written informed consent
- •participation in another investigational drug study
- •previous enrolment in this study
- •for women of childbearing potential no negative pregnancy test and no agree to use reliable method of birth control during the study
- •Pregnancy, giving birth within the last 90 days, or lactation
- •inability to cooperate with protocol requirements
研究组 & 干预措施
Ticagrelor
Experimental
干预措施: Ticagrelor (Drug)
Prasugrel
Active Comparator
干预措施: Prasugrel (Drug)
结局指标
主要结局
Composite of death, myocardial infarction or stroke
时间窗: 12 months
次要结局
- Mortality(12 months)
- Stroke(12 months)
- Stent Thrombosis(12 months)
- Bleeding(12 months)
- Myocardial Infarction(12 months)
研究者
研究点 (19)
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