Recruiting
Early Phase 1

Direct Oral Anticoagulant & High-Intensity Statin

Sponsor:

NYU Langone Health

Code:

NCT06961630

Conditions

Myocardial Injury After Noncardiac Surgery

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Interventions

Rivaroxaban

Atorvastatin

Study Details

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 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

Myocardial Injury After Noncardiac Surgery

Study ID

NCT06961630

Start date

Oct 7, 2025

Status verified date

Mar, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Rivaroxaban + Atorvastatin

Participants assigned to this arm will receive rivaroxaban 2.5mg twice daily + atorvastatin 80mg daily for 6 months.

no intervention: Usual Care

Participants assigned to usual care will continue all clinically indicated therapies as prescribed by their treating physicians.

Interventions

Rivaroxaban

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

Atorvastatin

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

Primary outcome measure

  • Percentage of pills taken at Month 6 [ Time Frame: Month 6 ]

Central Contacts and Locations

Central contacts

Nathaniel Smilowitz

212-263-5656Nathaniel.Smilowitz@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Apr 6, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-04-06.