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

NCT06961630 | Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: 24-012601R34HL173301-01A1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Percentage of pills taken at Month 6

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

  Month 6

Secondary Outcomes (1)

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

  Month 6

Study Arms (2)

Rivaroxaban + Atorvastatin

EXPERIMENTAL

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

Drug: Rivaroxaban; Drug: Atorvastatin

Usual Care

NO INTERVENTION

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

Interventions

Rivaroxaban DRUG

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

Rivaroxaban + Atorvastatin

Atorvastatin DRUG

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

Rivaroxaban + Atorvastatin

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Interventions

Rivaroxaban; Atorvastatin

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Nathaniel R. Smilowitz, MD, MS

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathaniel Smilowitz

CONTACT

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 8, 2025
• Study Start: October 7, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: October 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Data are available indefinitely for anyone who wishes to access the data for any purpose at: NHLBI BioData Catalyst (BDC), an existing NIH-supported Scientific Data Repository.

Locations

US (1)