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Search / Trial NCT06961630

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

Launched by NYU LANGONE HEALTH · May 6, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is exploring a new approach to help patients who experience heart issues after having non-cardiac surgeries, a condition known as Myocardial Injury after Noncardiac Surgery (MINS). The study aims to see if using specific medications, like blood thinners and powerful cholesterol-lowering drugs, is better than standard care for these patients. The researchers want to determine how well they can enroll participants for a larger study in the future and ensure that the study is designed effectively to help patients at higher risk for heart problems.

To be eligible for this trial, participants must be adults aged 45 or older who have undergone major surgery requiring at least one night in the hospital within the last two weeks and have experienced heart injury after that surgery. If someone joins the study, they will be asked to follow a treatment plan that may include new medications. It’s important to note that people with certain health issues, like severe bleeding disorders or specific liver and kidney problems, will not be able to participate. This trial is currently not recruiting participants, but once it begins, it will be an important step in finding better care for patients at risk of heart complications after surgery.

Gender

ALL

Eligibility criteria

  • 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

About Nyu Langone Health

NYU Langone Health is a premier academic medical center located in New York City, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a leading sponsor of clinical trials, NYU Langone Health integrates cutting-edge scientific inquiry with patient-centered care, striving to develop new therapies and improve health outcomes across a wide range of medical conditions. The institution is dedicated to fostering collaboration among researchers, clinicians, and patients, ensuring rigorous adherence to ethical standards and regulatory guidelines in all clinical research initiatives. By leveraging its extensive resources and expertise, NYU Langone Health aims to contribute significantly to the advancement of medical knowledge and the enhancement of patient care.

Locations

New York, New York, United States

Patients applied

0 patients applied

Trial Officials

Nathaniel R. Smilowitz, MD, MS

Principal Investigator

NYU Langone Health

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported