NCT06961630 Post-Operative Biomarker-Guided Precision Medicine For Cardiovascular Risk Reduction
| NCT ID | NCT06961630 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | NYU Langone Health |
| Condition | Myocardial Injury After Noncardiac Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-10-07 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2025-10-07 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Nathaniel R. Smilowitz, MD, MS
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT06961630 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, studying Myocardial Injury After Noncardiac Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06961630 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06961630 currently recruiting?
Yes, NCT06961630 is actively recruiting participants. Contact the research team at Nathaniel.Smilowitz@nyulangone.org for enrollment information.
Where is the NCT06961630 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06961630 clinical trial?
NCT06961630 is sponsored by NYU Langone Health. The principal investigator is Nathaniel R. Smilowitz, MD, MS at NYU Langone Health. The trial plans to enroll 50 participants.