LIBREXIA AF

A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation

The purpose of this study is to evaluate if milvexian is at least as effective as apixaban for reducing the risk of the composite stroke and non- central nervous system (CNS) systemic embolism.

Enrolment Criteria

Inclusion
- >18 years old
- Medically stable and appropriate for chronic antithrombotic treatment *
- AF/Fl ECG/holter documented past 30d AND med. Documented within past 1 year
- ≥ 75y.o. AND/OR History of a clinical symptomatic stroke of any type *
- ≥2 RISK FACTORS:
  - Age 65-74
  - HTN
  - DM
  - Vasc Dz, CAD, PCI, CABG
  - Symptomatic HF WITH HOSPITALIZATION OR LVEF ≤40%
- If on Warfarin, INR ≤2.0 at the time of randomization
- Not pregnant, lactating or planning to be*
- Accept lifestyle restrictions re: WOCBP, Con. meds
Exclusion
- Ischemic stroke past 7d
- Prior CNS bleeding event
- Significant valve disease, myxoma, LV thrombus, endocarditis
- Chronic anticoagulation
- Active active liver dz, dialysis
- Any significant drug allergy
- Abnormal labs:
  - eGFR <25 mL/min/1.73 m2
  - Platelet count <50,000 mm3
  - ALT >3x ULN
  - Total bilirubin ≥1.5x ULN*
  - Hemoglobin <8.0 g/dL
- Excluded meds:
  - Isoniazid
  - ASA>100mg/d
  - Clopidigrel WITH Omeprazole/esomeprazole
  - Additional OAC
  - Combined P-gp and strong CYP3A4 inhibitor past 7d
  - combined P-gp and strong CYP3A4/5 inducer past 7d