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New treatment option for Myocardial Injury After Noncardiac Surgery
Official title Post-Operative Biomarker-Guided Precision Medicine For Cardiovascular Risk Reduction
ClinicalTrials.gov ID: NCT06961630
What this study is testing
What is Rivaroxaban?
Rivaroxaban is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for myocardial injury after noncardiac surgery.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older
You may be able to join if
- 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%...
- Ability to provide informed consent
You likely can't join if
- 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
- Indication for dual antiplatelet therapy at discharge
- Patient already receiving or planned to receive moderate or high-intensity statin
See the full eligibility criteria
- 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
- 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
- Indication for dual antiplatelet therapy at discharge
- Patient already receiving or planned to receive moderate or high-intensity statin
- Contraindication to high-intensity statin
- Contraindication to rivaroxaban
- End stage kidney disease on hemodialysis
- Acute liver failure or decompensated cirrhosis
- Pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.