- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06961630
Post-Surgery Heart Risk Prevention: Rivaroxaban & Atorvastatin Clinical Trial
NYU Langone Health researchers are conducting an early phase 1 clinical trial to evaluate a precision medicine approach for patients experiencing myocardial injury after noncardiac surgery. The study will test whether combining rivaroxaban (a blood thinner) and atorvastatin (a cholesterol medication) can effectively reduce cardiovascular risks in post-operative patients.
The trial aims to enroll 50 eligible adults aged 45+ who underwent major non-cardiac surgery with subsequent myocardial injury, as evidenced by elevated troponin levels. Participants will be randomly assigned to either receive the drug combination or continue with standard care for six months.
Key study details include:
- Experimental group receives rivaroxaban 2.5mg twice daily + atorvastatin 80mg daily
- Control group continues with physician-directed standard care
- Primary outcome measures medication adherence at 6 months
- Secondary outcomes assess quality of life through validated questionnaires
Exclusion criteria focus on patient safety, including those with bleeding disorders, pre-existing anticoagulation needs, or contraindications to study medications. The trial is open-label, meaning both participants and researchers will know which treatment is being administered.
This pilot study (expected completion March 2027) represents an important step toward developing targeted post-surgical care strategies for at-risk patients. Results may inform future larger-scale trials and potentially change clinical practice for managing post-operative myocardial injury.