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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Rivaroxaban 2.5mg will be orally administered twice daily for 6 months.
Atorvastatin 80mg will be orally administered daily for 6 months.
NYU Langone Health
New York, New York, United States
RECRUITINGPercentage of pills taken at Month 6
Treatment adherence will be assessed by pill count and patient self report.
Time frame: Month 6
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
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