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A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation
Recruiting
Trial ID: NCT05757869
Purpose
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.
Official Title
A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Active-Controlled Study to Evaluate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, Versus Apixaban in Participants With Atrial Fibrillation
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
- Minimum age of 18 years
- Medically stable and appropriate for chronic antithrombotic treatment
- Atrial fibrillation eligible to receive anticoagulation
- Participant must satisfy one or both of the following categories of risk factors (a or
b): a) one or more of the following risk factors: i) age greater than or equal to 75
years, ii) history of any type of stroke including symptomatic stroke of any kind. b)
two or more of the following risk factors: i) age between 65 and 74 years, ii)
hypertension, iii) diabetes mellitus, iv) atherosclerotic vascular disease, v) heart
failure
Exclusion Criteria:
- Hemodynamically significant valve disease or those with valve disease that will
potentially require surgical valve replacement during the study
- Any condition other than AF that requires chronic anticoagulation
Intervention(s):
drug: Milvexian
drug: Apixaban
drug: Placebo
drug: Apixaban Placebo
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305