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

ConditionMyocardial Injury After Noncardiac Surgery

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Rivaroxaban
Drug
Rivaroxaban 2.5mg will be orally administered twice daily for 6 months.
Atorvastatin
Drug
Atorvastatin 80mg will be orally administered daily for 6 months.

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: Rivaroxaban + AtorvastatinExperimental treatment 2 interventions

Group B: Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

Percentage of pills taken at Month 6

Treatment adherence will be assessed by pill count and patient self report.

Time frame

Month 6

Secondary outcomes

Percentage of Quality of Life (QOL) questionnaires completed at Month 6

Two QOL questionnaires (Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS-10) and EuroQol 5 Dimension (EQ5D)) will be administered at baseline, 2-month follow-up visit, and the 6-month follow-up visit.

Time frame

Month 6

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov

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