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NCT Number: NCT06961630

Post-Operative Biomarker-Guided Precision Medicine For Cardiovascular Risk Reduction

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.

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Key information

Conditions

Myocardial Injury After Noncardiac Surgery

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Rivaroxaban

Drug

Rivaroxaban 2.5mg will be orally administered twice daily for 6 months.

atorvastatin

Drug

Atorvastatin 80mg will be orally administered daily for 6 months.

Primary outcomes

  1. Percentage of pills taken at Month 6

    Time frame: Month 6

    Treatment adherence will be assessed by pill count and patient self report.

Secondary outcomes

  1. Percentage of Quality of Life (QOL) questionnaires completed at Month 6

    Time frame: Month 6

    Two QOL questionnaires (Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS-10) and EuroQol 5 Dimension (EQ5D)) will be administered at baseline, 2-month follow-up visit, and the 6-month follow-up visit.

Study contacts

Contact information is provided by the study sponsor or research team.

Nathaniel Smilowitz

CONTACT

[email protected]

212-263-5656

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

A Pilot Randomized Trial of Post-Operative Biomarker-Guided Precision Medicine With Rivaroxaban and Atorvastatin for Cardiovascular Risk-Reduction

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 8, 2025
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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