Biomarker-guided post-operative treatment to lower heart risk after non-cardiac surgery
A Pilot Randomized Trial of Post-Operative Biomarker-Guided Precision Medicine With Rivaroxaban and Atorvastatin for Cardiovascular Risk-Reduction
This pilot will test whether adding a low-dose blood thinner (rivaroxaban) plus a high-intensity statin (atorvastatin) to usual care helps people aged 45 and older who had a heart injury after non-cardiac surgery.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06961630 on ClinicalTrials.gov |
What this trial studies
This is a pilot randomized trial comparing a combined regimen of low-dose rivaroxaban and high-intensity atorvastatin versus usual care in patients with myocardial injury after noncardiac surgery (MINS). The study enrolls adults ≥45 years who had major noncardiac surgery within 14 days and meet troponin-based criteria for MINS, and it excludes those with high bleeding risk, indications for full anticoagulation or dual antiplatelet therapy, advanced renal replacement therapy, or severe liver disease. Primary aims are to test enrollment feasibility, medication adherence, and to refine entry criteria, endpoints, sample size, and site selection for a larger multicenter randomized trial. Outcomes from this pilot will inform the design of a future definitive trial of biomarker-guided post-operative cardiovascular prevention.
Who should consider this trial
Good fit: Adults aged 45 or older who had major non-cardiac surgery within the prior 14 days and have biomarker evidence of myocardial injury (post-operative troponin ≥99th percentile with a rise/fall >20%) and can safely take a statin and low-dose anticoagulant are ideal candidates.
Not a fit: Patients with high bleeding risk, required or planned full anticoagulation or dual antiplatelet therapy, end-stage kidney disease on hemodialysis, acute liver failure or decompensated cirrhosis, current moderate/high-intensity statin therapy, pregnancy, or expected survival under six months are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could reduce post-operative heart attacks and other cardiovascular events in patients with MINS.
How similar studies have performed: Direct oral anticoagulants and high-intensity statins have proven benefits in other cardiovascular contexts, but applying a biomarker-guided combination approach specifically for MINS is largely untested in randomized trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Nathaniel R. Smilowitz, MD, MS — NYU Langone Health
- Study coordinator: Nathaniel Smilowitz
- Email: Nathaniel.Smilowitz@nyulangone.org
- Phone: 212-263-5656
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.