A Study of Milvexian Versus Apixaban in Participants with Atrial Fibrillation

JRCT ID: jRCT2051230052

Registered date:25/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Atrial Fibrillation
• Date of first enrollment: 27/07/2023
• Target sample size: 15500
• Countries of recruitment: United States Of America,Japan,Argentina,Japan,Australia,Japan,Belgium,Japan,Brazil,Japan,Bulgaria,Japan,Canada,Japan,Chile,Japan,China,Japan,Croatia,Japan,Czechia,Japan,Denmark,Japan,Estonia,Japan,France,Japan,Germany,Japan,Greece,Japan,Hong Kong,Japan,Hungary,Japan,India,Japan,Israel,Japan,Italy,Japan,Republic OfKorea,Japan,Latvia,Japan,Lithuania,Japan,Malaysia,Japan,Mexico,Japan,Netherlands,Japan,New Zealand,Japan,Philippines,Japan,Poland,Japan
• Study type: Interventional

Intervention(s)

Milvexian : Milvexian will be administered orally. : Participant will receive milvexian and placebo that matches apixaban beginning on Day 1 through end of treatment (EOT). Participants after the EOT visit may have an option to receive open-label apixaban at the appropriate dose, for which the sponsor provides a 30-day supply.

Apixaban : Apixaban will be administered orally. : Participants will receive a placebo that matches milvexian and a capsule containing apixaban. Participants after the EOT visit may have an option to receive open-label apixaban at the appropriate dose, for which the sponsor provides a 30-day supply.

Placebo : Milvexian matching milvexian placebo will be administered orally.

Apixaban Placebo : Apixaban matching apixaban placebo will be administered orally.

Outcome(s)

• Primary Outcome: Time to the First Occurrence of Composite Endpoint of Stroke and Non-central nervous system (CNS) Systemic Embolism : Up to 4 years : Time to the first occurrence of composite endpoint of stroke and non-CNS systemic embolism will be reported.

Secondary Outcome

Time to the First Occurrence of International Society of Thrombosis and Hemostasis (ISTH) Major Bleeding : Up to 4 years : Time to the first occurrence of ISTH major bleeding will be reported.

Time to the First Occurrence of the Composite of ISTH Major and Clinically Relevant Non-major (CRNM) Bleeding : Up to 4 years : Time to the first occurrence of the composite of ISTH major and CRNM bleeding will be reported.

Time to the First Occurrence of Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, and Non-CNS Systemic Embolism : Up to 4 years : Time to the first occurrence of composite endpoint of CV death, MI, stroke, and non-CNS systemic embolism will be reported.

Time to CV Death : Up to 4 years : Time to CV death will be reported.

Time to the First Occurrence of Composite Endpoint of All-cause Death, MI, Stroke and Non-CNS Systemic Embolism : Up to 4 years : Time to the first occurrence of composite endpoint of all-cause death, MI, stroke and Non-CNS systemic embolism will be reported.

Time to the First Occurrence of Composite Endpoint of CV Death, MI, Stroke, Acute Limb Ischemia (ALI), and Urgent Hospitalization for Vascular cause of Ischemic Nature : Up to 4 years : Time to the first occurrence of composite endpoint of CV death, MI, stroke, ALI [any unanticipated revascularization or amputation of ischemic limb]), and urgent hospitalization for vascular cause of ischemic nature (including deep vein thrombosis [DVT] and pulmonary embolism [PE]) will be reported.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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 a clinical symptomatic stroke. 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

Exclude 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

Related Information

• Primary Sponsor: Numaguchi Hirotaka
• Source(s) of Monetary Support: Bristol-Myers Squibb K.K.
• Secondary ID(s): NCT05757869