A Randomized, Double-Blind, Placebo-Controlled, Event-Driven Multicenter Study to Evaluate the Efficacy and Safety of Rivaroxaban in Subjects With a Recent Acute Coronary Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 15,527
- 试验地点
- 54
- 主要终点
- Primary efficacy endpoint is the composite of CV death, MI, or stroke.
研究概览
简要总结
The purpose of this study is to determine whether rivaroxaban in addition to standard care reduces the risk of the composite of cardiovascular death, myocardial infarction, or stroke in patients with a recent acute coronary syndrome compared with placebo.
Acute coronary syndrome (ACS) is a serious and life threatening condition. Following an acute coronary syndrome event patients are at risk of important additional clinical events such as death, myocardial infarction, and stroke. Six months after patients present with an index event of ST-segment myocardial infarction, approximately 15% will either have died or had another episode of myocardial ischemia, and a similar situation exists for non-ST-segment elevation myocardial infarction/unstable angina patients. This randomized; double-blind; placebo controlled study will evaluate the efficacy and safety of rivaroxaban in addition to standard care in patients with a recent ACS. Patients will be given rivaroxaban (2.5 mg twice daily or 5 mg twice daily) or placebo (twice daily) in addition to standard care.
India: 1550 patients screened, 1469 patients randomized, FPI: 10-Mar-2009, First subject randomized: 17-Mar-2009, Last Patient Enroled : 24-Dec-2010, Last Patient Last Visit : 09-Sep-2011
研究设计
- 研究类型
- Interventional
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
入选标准
- •Inclusion Criteria: Ages Eligible for Study: 18 Years and older.
- •There is no upper age limit for this study.
- •Genders Eligible for Study: Both Patients must be currently receiving aspirin therapy alone or in combination with a thienopyridine per national or local dosing recommendation :Have been hospitalized for symptoms suggestive of acute coronary syndrome that lasted at least 10 minutes at rest and occurred 48 hours or less before going to the hospital.
排除标准
- •Exclusion Criteria: Patient below 18 years of age.
- •Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding Need for continued anticoagulant therapy Significant renal impairment or known significant liver disease.
结局指标
主要结局
Primary efficacy endpoint is the composite of CV death, MI, or stroke.
时间窗: 6-day screening phase,- treatment phase (consisting of double-blind treatment and follow-up) extending from Day 1 (baseline). - enrollment period estimated to last 27 months, the double-blind treatment phase will last for an additional 6 months, and the follow-up period will last 30 days, making the total study duration approximately 34 months. Study will end when at least 983 primary efficacy endpoints accrue across both strata, and at least 728 primary efficacy endpoints in Stratum 2
次要结局
- The composite of all cause death, MI, or stroke. - Net clinical outcome, defined as the composite of CV death, MI, ischemic stroke, or TIMI major bleeding event not associated with CABG surgery - Assessments of the composite of CV death, MI, stroke, or severe recurrent ischemia requiring revascularization. - Assessments of the composite of CV death, MI, stroke, or severe recurrent ischemia leading to hospitalization.(6-day screening phase,- treatment phase (consisting of double-blind treatment and follow-up) extending from Day 1 (baseline). - enrollment period estimated to last 27 months, the double-blind treatment phase will last for an additional 6 months, and the follow-up period will last 30 days, making the total study duration approximately 34 months. Study will end when at least 983 primary efficacy endpoints accrue across both strata, and at least 728 primary efficacy endpoints in Stratum 2- FPI: 28-Nov-2008, - LPI: 30-Jan-2011, - LPO: 27-Jun-2011)