Atrial Fibrillation
Conditions
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.
Interventions
DRUGMilvexian
Milvexian will be administered orally.
DRUGApixaban
Apixaban will be administered orally.
DRUGPlacebo
Milvexian matching milvexian placebo will be administered orally.
DRUGApixaban Placebo
Apixaban matching apixaban placebo will be administered orally.
Sponsors
Janssen Research & Development, LLC
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Netherlands, New Zealand, Philippines, Poland, Portugal, Romania, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
Contacts
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Outcome results
None listed