Actively Recruiting
Post-Operative Biomarker-Guided Precision Medicine For Cardiovascular Risk Reduction
Led by NYU Langone Health · Updated on 2026-04-06
50
Participants Needed
1
Research Sites
77 weeks
Total Duration
On this page
Sponsors
N
NYU Langone Health
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Post-Operative Biomarker-Guided Precision Medicine For Cardiovascular Risk Reduction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 45 years or older
- Underwent major non-cardiac surgery requiring at least one overnight hospital stay within the past 14 days
- Experienced myocardial injury after non-cardiac surgery, defined by post-operative troponin levels at or above the 99th percentile upper reference limit with a rise or fall greater than 20% indicating acute injury
- Able to provide informed consent
You will not qualify if you...
- Expected survival less than 6 months
- Presence of hemorrhagic disorder
- Surgeon deems it unsafe to start low-dose anticoagulation within 14 days after surgery
- Need for oral anticoagulation at discharge
- Need for dual antiplatelet therapy at discharge
- Currently receiving or planned to receive moderate or high-intensity statin therapy
- Contraindication to high-intensity statin
- Contraindication to rivaroxaban
- End-stage kidney disease requiring hemodialysis
- Acute liver failure or decompensated cirrhosis
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
Research Team
N
Nathaniel Smilowitz
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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