Biomarker-guided post-operative treatment to lower heart risk after non-cardiac surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.