Myocardial Injury After Noncardiac Surgery
Conditions
Brief summary
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
DRUGRivaroxaban
Rivaroxaban 2.5mg will be orally administered twice daily for 6 months.
DRUGAtorvastatin
Atorvastatin 80mg will be orally administered daily for 6 months.
Sponsors
NYU Langone Health
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults ≥45 years 2. Underwent major non-cardiac surgery requiring ≥1 overnight inpatient stay in the prior 14 days 3. 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. 4. Ability to provide informed consent
Exclusion criteria
1. Expected survival \<6 months 2. Hemorrhagic disorder 3. Surgeon feels it is unsafe to initiate low-dose anticoagulation within 14 days of surgery 4. Indication for oral anticoagulation at discharge 5. Indication for dual antiplatelet therapy at discharge 6. Patient already receiving or planned to receive moderate or high-intensity statin 7. Contraindication to high-intensity statin 8. Contraindication to rivaroxaban 9. End stage kidney disease on hemodialysis 10. Acute liver failure or decompensated cirrhosis 11. Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of pills taken at Month 6 | Month 6 | Treatment adherence will be assessed by pill count and patient self report. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Quality of Life (QOL) questionnaires completed at Month 6 | 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. |
Countries
United States
Contacts
CONTACTNathaniel Smilowitz
PRINCIPAL_INVESTIGATORNathaniel R. Smilowitz, MD, MS
NYU Langone Health
Outcome results
None listed