Status:
RECRUITING
Post-Operative Biomarker-Guided Precision Medicine For Cardiovascular Risk Reduction
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Myocardial Injury After Noncardiac Surgery
Eligibility:
All Genders
45+ years
Phase:
EARLY_PHASE1
Brief 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 Inju...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Pregnancy
Key Trial Info
Start Date :
October 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06961630
Start Date
October 7 2025
End Date
March 31 2027
Last Update
October 9 2025
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016