A Pilot Randomized Trial of Post-Operative Biomarker-Guided Precision Medicine With Rivaroxaban and Atorvastatin for Cardiovascular Risk-Reduction
NYU Langone Health
Summary
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.
Eligibility
- Age range
- 45+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Adults ≥45 years 2. Underwent major non-cardiac surgery requiring ≥1 overnight inpatient stay in the prior 14 days 3. 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. 4. Ability to provide informed consent Exclusion Criteria: 1. Expected survival \<6 months 2. Hemorrhagic disorder 3. Surgeon feels it is unsafe to initiate low-dose anticoagulation within 14 days of surgery 4. Indication for oral anticoagulation at discharge 5. Ind…
Interventions
- DrugRivaroxaban
Rivaroxaban 2.5mg will be orally administered twice daily for 6 months.
- DrugAtorvastatin
Atorvastatin 80mg will be orally administered daily for 6 months.
Location
- NYU Langone HealthNew York, New York