NCT06961630 · NYU Langone Health
Post-Operative Biomarker-Guided Precision Medicine For Cardiovascular Risk Reduction
What this study is about
The goal of this pilot study is to assess enrollment feasibility of a randomly assigned trial of direct taken by mouth anticoagulant and high-intensity statin therapy versus usual care in patients with Myocardial Injury after Noncardiac Surgery (MINS).
View original scientific description
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.
Interventions
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.
Primary outcome measures
Percentage of pills taken at Month 6
Time frame: Month 6
Treatment adherence will be assessed by pill count and patient self report.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
Where
- New York, New York
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 6, 2026 · Source of record for eligibility and locations