Trials / Recruiting
RecruitingNCT06961630
Post-Operative Biomarker-Guided Precision Medicine For Cardiovascular Risk Reduction
A Pilot Randomized Trial of Post-Operative Biomarker-Guided Precision Medicine With Rivaroxaban and Atorvastatin for Cardiovascular Risk-Reduction
- Status
- Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- NYU Langone Health · Academic / Other
- Sex
- All
- Age
- 45 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rivaroxaban | Rivaroxaban 2.5mg will be orally administered twice daily for 6 months. |
| DRUG | Atorvastatin | Atorvastatin 80mg will be orally administered daily for 6 months. |
Timeline
- Start date
- 2025-10-07
- Primary completion
- 2027-03-31
- Completion
- 2027-03-31
- First posted
- 2025-05-08
- Last updated
- 2026-04-06
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06961630. Inclusion in this directory is not an endorsement.