Rivaroxaban + Atorvastatin for Heart Attack Risk
Trial Summary
What is the purpose of 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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are already on a moderate or high-intensity statin, you cannot participate. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug combination of Rivaroxaban and Atorvastatin for reducing heart attack risk?
Research shows that combining low-dose Rivaroxaban with aspirin significantly reduces the risk of heart attacks, strokes, and other major cardiovascular events in patients with stable coronary artery disease. Although Atorvastatin is not directly mentioned in the studies, it is commonly used to lower cholesterol and reduce heart attack risk, suggesting that combining it with Rivaroxaban could be beneficial.12345
Is the combination of Rivaroxaban and Atorvastatin safe for humans?
Rivaroxaban has been shown to have a generally favorable safety profile, with a lower risk of fatal bleeding compared to some other blood thinners, although it may increase the risk of certain events in high-risk patients with specific conditions. Atorvastatin is widely used and generally considered safe, but combining it with Rivaroxaban for heart attack risk specifically hasn't been extensively studied, so it's important to consult with a healthcare provider.678910
How does the drug combination of Rivaroxaban and Atorvastatin for heart attack risk differ from other treatments?
The combination of Rivaroxaban and Atorvastatin is unique because it combines a blood thinner (Rivaroxaban) with a cholesterol-lowering drug (Atorvastatin) to potentially reduce heart attack risk. This dual approach targets both blood clot prevention and cholesterol management, which is different from treatments that focus on only one of these aspects.67101112
Research Team
Nathaniel R. Smilowitz, MD, MS
Principal Investigator
NYU Langone Health
Eligibility Criteria
This trial is for patients who have experienced a heart attack after surgery not related to the heart (MINS). It's testing if using Rivaroxaban, an anticoagulant, and Atorvastatin, a statin, can help manage cardiovascular risk better than usual care. Participants must meet certain health criteria to join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive rivaroxaban 2.5mg twice daily and atorvastatin 80mg daily for 6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment, including completion of QOL questionnaires
Treatment Details
Interventions
- Atorvastatin
- Rivaroxaban
Find a Clinic Near You
Who Is Running the Clinical Trial?
NYU Langone Health
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator