Post-Operative Biomarker-Guided Precision Medicine For Cardiovascular Risk Reduction
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age45+
SponsorNYU Langone Health
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Rivaroxaban
- Atorvastatin
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
NYU Langone Health
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov