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

Conditions

• Myocardial Injury After Noncardiac Surgery

Eligibility Criteria

Sex

ALL

Age

45 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Oct 7, 2025

Status verified

Mar 2026

Primary completion

Mar 31, 2027

Completion

Mar 31, 2027

Study Design

Enrollment

50 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

• Nathaniel Smilowitz
  212-263-5656
  [email protected]

Locations (1)

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