NCT06961630EARLY_PHASE1Recruiting
Post-Operative Biomarker-Guided Precision Medicine For Cardiovascular Risk Reduction
NYU Langone Health
Start Date
10/7/2025
Completion Date
3/31/2027
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 Criteria
Age Range: 45 years to No maximum
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. Indication for dual antiplatelet therapy at discharge
6. Patient already receiving or planned to receive moderate or high-intensity statin
7. Contraindication to high-intensity statin
8. Contraindication to rivaroxaban
9. End stage kidney disease on hemodialysis
10. Acute liver failure or decompensated cirrhosis
11. Pregnancy
Interventions
DRUG
Rivaroxaban
DRUG
Atorvastatin
Conditions
Myocardial Injury After Noncardiac Surgery
Locations
NYU Langone Health
New York, New York 10016
United States