A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation
- Conditions
- Atrial Fibrillation
- Interventions
- Registration Number
- NCT05757869
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 20296
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Milvexian Placebo Participants will receive milvexian 100 milligrams (mg) orally, twice daily 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 (5 mg or 2.5 mg, twice daily), for which the sponsor provides a 30-day supply. Apixaban Apixaban Placebo Participants will receive a placebo that matches milvexian and a capsule containing apixaban 5 mg or 2.5 mg orally, twice daily. Participants after the EOT visit may have an option to receive open-label apixaban (5 mg or 2.5 mg, twice daily) at the appropriate dose, for which the sponsor provides a 30-day supply. Apixaban Apixaban Participants will receive a placebo that matches milvexian and a capsule containing apixaban 5 mg or 2.5 mg orally, twice daily. Participants after the EOT visit may have an option to receive open-label apixaban (5 mg or 2.5 mg, twice daily) at the appropriate dose, for which the sponsor provides a 30-day supply. Milvexian Milvexian Participants will receive milvexian 100 milligrams (mg) orally, twice daily 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 (5 mg or 2.5 mg, twice daily), for which the sponsor provides a 30-day supply.
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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 Stroke, Non-CNS Systemic Embolism and ISTH Major Bleeding Up to 4 years Time to the first occurrence of composite endpoint of stroke, non-CNS systemic embolism and ISTH major 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.
Trial Locations
- Locations (1030)
Advanced Cardiovascular, LLC
🇺🇸Alexander City, Alabama, United States
Ascension St. Vincent's Health System
🇺🇸Birmingham, Alabama, United States
SEC Clinical Research
🇺🇸Dothan, Alabama, United States
HH Heart Center and Heart Center
🇺🇸Huntsville, Alabama, United States
CB Flock Research Corporation
🇺🇸Mobile, Alabama, United States
Mercy Gilbert Medical Center
🇺🇸Gilbert, Arizona, United States
Valleywise Health Medical Center
🇺🇸Phoenix, Arizona, United States
Arizona Arrhythmia Research Center
🇺🇸Phoenix, Arizona, United States
Arizona Heart Hospital
🇺🇸Phoenix, Arizona, United States
HonorHealth Neurology
🇺🇸Scottsdale, Arizona, United States
Scroll for more (1020 remaining)Advanced Cardiovascular, LLC🇺🇸Alexander City, Alabama, United States