Post-Operative Biomarker-Guided Precision Medicine For Cardiovascular Risk Reduction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rivaroxaban, Atorvastatin.
- Who it may be relevant to
- Registry conditions: Myocardial Injury After Noncardiac Surgery. Basic parameters: from 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Pilot Randomized Trial of Post-Operative Biomarker-Guided Precision Medicine With Rivaroxaban and Atorvastatin for Cardiovascular Risk-Reduction
Overview
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.
Interventions
- Drug Rivaroxaban
Rivaroxaban 2.5mg will be orally administered twice daily for 6 months. - Drug Atorvastatin
Atorvastatin 80mg will be orally administered daily for 6 months.
Primary outcome measures
- Percentage of pills taken at Month 6 [Time frame: Month 6]
Secondary outcome measures (1)
- Percentage of Quality of Life (QOL) questionnaires completed at Month 6 [Time frame: Month 6]
Eligibility criteria
Inclusion 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT06961630 · 24-01260 · 1R34HL173301-01A1