A Pilot Randomized Trial of Post-Operative Biomarker-Guided Precision Medicine With Rivaroxaban and Atorvastatin for Cardiovascular Risk-Reduction
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Percentage of pills taken at Month 6
研究概览
简要总结
The goal of this pilot study is to assess enrollment feasibility of a randomized trial of direct oral anticoagulant and high-intensity statin therapy versus usual care in patients with Myocardial Injury after Noncardiac Surgery (MINS). The primary aims of this study are to assess feasibility, study drug adherence, and optimize study design (entry criteria, study endpoints, sample size calculation, site selection) and recruitment strategies for the future multicenter randomized clinical trial studying biomarker-based care in post-operative patients at elevated cardiovascular (CV) risk.
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
- None
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
- •Adults ≥45 years
- •Underwent major non-cardiac surgery requiring ≥1 overnight inpatient stay in the prior 14 days
- •Myocardial injury after noncardiac surgery, defined as a post-operative troponin ≥ 99th percentile upper reference limit [URL], with rise/fall >20% indicative of acute myocardial injury.
- •Ability to provide informed consent
排除标准
- •Expected survival <6 months
- •Hemorrhagic disorder
- •Surgeon feels it is unsafe to initiate low-dose anticoagulation within 14 days of surgery
- •Indication for oral anticoagulation at discharge
- •Indication for dual antiplatelet therapy at discharge
- •Patient already receiving or planned to receive moderate or high-intensity statin
- •Contraindication to high-intensity statin
- •Contraindication to rivaroxaban
- •End stage kidney disease on hemodialysis
- •Acute liver failure or decompensated cirrhosis
研究组 & 干预措施
Usual Care
Participants assigned to usual care will continue all clinically indicated therapies as prescribed by their treating physicians.
Rivaroxaban + Atorvastatin
Participants assigned to this arm will receive rivaroxaban 2.5mg twice daily + atorvastatin 80mg daily for 6 months.
干预措施: Rivaroxaban (Drug)
Rivaroxaban + Atorvastatin
Participants assigned to this arm will receive rivaroxaban 2.5mg twice daily + atorvastatin 80mg daily for 6 months.
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Percentage of pills taken at Month 6
时间窗: Month 6
Treatment adherence will be assessed by pill count and patient self report.
次要结局
- Percentage of Quality of Life (QOL) questionnaires completed at Month 6(Month 6)