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

NYU Langone Health

Status and phase: Enrolling; Early Phase 1

Conditions: Myocardial Injury After Noncardiac Surgery

Treatments: Drug: Atorvastatin; Drug: Rivaroxaban

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06961630

24-01260

1R34HL173301-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Rivaroxaban + Atorvastatin

Experimental group

Description:

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

Treatment:

Drug: Rivaroxaban

Drug: Atorvastatin

Usual Care

No Intervention group

Description:

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