Rivaroxaban in Type 2 Myocardial Infarctions: A Feasibility, Placebo-controlled, Double-blinded, Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Feasibility outcome
研究概览
简要总结
This trial is the pilot phase of a randomized controlled trial to test the feasibility of recruiting patients with a type 2 myocardial infarction and randomizing them to low-dose rivaroxaban to reduce the risk of major cardiovascular events.
详细描述
This trial is an investigator-initiated prospective, single-center, placebo-controlled, double blinded, pilot randomized controlled trial of low-dose rivaroxaban (2.5mg oral twice daily) for 90-days following a type 2 myocardial infarction. The primary feasibility outcome is time to recruitment of 100 participants, stratified by sex.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant age ≥ 65years or >45 years and an additional risk factor (smoking, diabetes mellitus, hypertension, dyslipidemia or known atherosclerotic disease)
- •Rise in troponin level, with one troponin value above the 99th percentile of the upper limit of normal deemed to be due to a type 2 myocardial infarction by the attending team within the past 30 days
- •Alive at the time of hospital discharge
排除标准
- •Current use of anticoagulation
- •Current use of dual antiplatelet therapy
- •Advanced kidney disease (eGFR <15ml/min)
- •Previous hemorrhagic stroke at any time or embolic stroke within the past year
- •Previous life-threatening bleeding event
- •Life expectancy less than one year
- •Anticoagulation recommended conditions - atrial fibrillation, pulmonary embolism, deep vein thrombosis, mechanical heart valves, rheumatic mitral valve disease, left ventricular thrombosis
- •Surgery in the previous 30 days
- •Inability to provide informed consent in English
- •Pregnancy, breastfeeding or child bearing potential
研究组 & 干预措施
Placebo
Oral placebo tablet twice daily for 90-days
干预措施: Placebo (Drug)
Rivaroxaban
Rivaroxaban 2.5mg oral twice daily for 90-days
干预措施: Rivaroxaban 2.5 MG [Xarelto] (Drug)
结局指标
主要结局
Feasibility outcome
时间窗: Through study completion, estimated at 1-year
Time to recruitment of 100 participants, stratified by sex.
次要结局
- Number of participants who experience a composite of death, stroke or myocardial infarction(90-days)
- Number of participants who experience major bleeding(90-days)