RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

A Pilot Randomized Trial of Post-Operative Biomarker-Guided Precision Medicine With Rivaroxaban and Atorvastatin for Cardiovascular Risk-Reduction

Quick Facts

Study Start:2025-10-07
Study Completion:2027-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06961630

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adults ≥45 years
  2. 2. Underwent major non-cardiac surgery requiring ≥1 overnight inpatient stay in the prior 14 days
  3. 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. 4. Ability to provide informed consent
  1. 1. Expected survival \<6 months
  2. 2. Hemorrhagic disorder
  3. 3. Surgeon feels it is unsafe to initiate low-dose anticoagulation within 14 days of surgery
  4. 4. Indication for oral anticoagulation at discharge
  5. 5. Indication for dual antiplatelet therapy at discharge
  6. 6. Patient already receiving or planned to receive moderate or high-intensity statin
  7. 7. Contraindication to high-intensity statin
  8. 8. Contraindication to rivaroxaban
  9. 9. End stage kidney disease on hemodialysis
  10. 10. Acute liver failure or decompensated cirrhosis
  11. 11. Pregnancy

Contacts and Locations

Study Contact

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

Principal Investigator

Nathaniel R. Smilowitz, MD, MS
PRINCIPAL_INVESTIGATOR
NYU Langone Health

Study Locations (Sites)

NYU Langone Health
New York, New York, 10016
United States

Collaborators and Investigators

Sponsor: NYU Langone Health

  • Nathaniel R. Smilowitz, MD, MS, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-10-07
Study Completion Date2027-03-31

Study Record Updates

Study Start Date2025-10-07
Study Completion Date2027-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Myocardial Injury After Noncardiac Surgery