(19767 OCEANIC-AF) A multicenter, international, randomized, active comparator-controlled, double-blind, double-dummy, parallel-group, 2-arm, Phase 3 study to compare the efficacy and safety of the oral FXIa inhibitor asundexian (BAY 2433334) with apixaban for the prevention of stroke or systemic embolism in male and female participants aged 18 years and older with atrial fibrillation at risk for stroke
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer AG
- 入组人数
- 9,578
- 试验地点
- 425
- 主要终点
- Time to first occurrence of composite of stroke or systemic embolism
研究概览
简要总结
To demonstrate that asundexian is superior (at least non-inferior) when compared with apixaban for prevention of stroke and systemic embolism in participants with atrial fibrillation at risk for stroke. To demonstrate that asundexian is superior to apixaban as assessed by International Society on Thrombosis and Hemostasis (ISTH) major bleeding in participants with atrial fibrillation at risk for stroke. To demonstrate that asundexian is superior to apixaban with respect to benefit and risk.
研究设计
- 分配方式
- Randomized
- 主要目的
- Overall
- 盲法
- Double (Investigator, Monitor, Analyst, Subject, Carer)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older (at legal age of consent according to local legislation) at the time of signing the informed consent
- •Atrial fibrillation documented by ECG evidence with an indication for indefinite treatment with an oral anticoagulant
- •CHA2DS2-VASc score >=3 if male or >= 4 if female, OR CHA2DS2-VASc score of 2 if male or 3 if female and enrichment criteria.
排除标准
- •Mechanical heart valve prosthesis
- •Moderate-to-severe mitral stenosis at the time of inclusion into the study
- •Atrial fibrillation only due to reversible cause
- •Requirement for chronic anticoagulation for a different indication than atrial fibrillation
结局指标
主要结局
Time to first occurrence of composite of stroke or systemic embolism
Time to first occurrence of composite of stroke or systemic embolism
Time to first occurrence of ISTH major bleeding
Time to first occurrence of ISTH major bleeding
Time to first occurrence of composite of stroke, systemic embolism, or ISTH major bleeding
Time to first occurrence of composite of stroke, systemic embolism, or ISTH major bleeding
次要结局
- Time to first occurrence of composite of ischemic stroke or systemic embolism
- Time to first occurrence of all-cause mortality
- Time to first occurrence of ischemic stroke
- Time to first occurrence of cardiovascular (CV) death
- Time to first occurrence of composite of CV death, stroke, or myocardial infarction
- Time to first occurrence of composite of ISTH major or clinically relevant non-major bleeding
- Time to first occurrence of clinically relevant non-major bleeding
- Time to first occurrence of hemorrhagic stroke
- Time to first occurrence of intracranial hemorrhage
- Time to first occurrence of fatal bleeding
- Time to first occurrence of minor bleeding
- Time to first occurrence of composite of stroke, systemic embolism, ISTH major bleeding, or all-cause mortality
- Time to first occurrence of composite of disabling stroke (modified Rankin Scale (mRS) >=3), critical bleeding, or all-cause mortality
研究者
Therapeutic Area Head
Scientific
Bayer AG