A multicenter, international, randomized, active comparator-controlled, double-blind, doubledummy,parallel-group, 2-arm, Phase 3 study to compare the efficacy and safety of the oralFXIa inhibitor asundexian (BAY 2433334) with apixaban for the prevention of stroke orsystemic embolism in male and female participants aged 18 years and older with atrialfibrillation at risk for stroke
试验速览
- 阶段
- 3 期
- 状态
- Other
- 发起方
- 入组人数
- 18,000
- 试验地点
- 6
- 主要终点
- Time to first occurrence of composite of stroke or systemic embolism
研究概览
简要总结
Atrial Fibrillation (AF) is the most common sustained cardiac arrhythmia and is associated with increased rates of death, stroke and other thromboembolic events.
Current treatment guidelines recommend the use of long-term oral anticoagulant therapy such as VKAs, or NOACs in patients with AF at risk for stroke.
This pivotal Phase 3 study will evaluate the efficacy and safety of asundexian compared with apixaban for the prevention of stroke or systemic embolism in participants with atrial fibrillation.
Asundexian, as an oral FXIa inhibitor, is expected to show a benefit in reducing the risk for stroke or systemic embolism in patients with AF in Phase 3.
Asundexian is therefore an attractive candidate to be evaluated as a potential replacement for NOAC therapy in patients with AF.
In conclusion, asundexian is believed to represent a potentially improved new therapeutic option for thrombosis prevention in life-threatening thrombotic diseases with superior bleeding safety compared to oral anticoagulants and without a significant increase in bleeding risk on top of available antiplatelet therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
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
时间窗: Up to 34 months
次要结局
- Time to first occurrence of cardiovascular (CV) death(Up to 34 months)
- Time to first occurrence of composite of CV death, stroke, or myocardial infarction(Up to 34 months)
- Time to first occurrence of composite of ischemic stroke or systemic embolism(Up to 34 months)
- Time to first occurrence of all-cause mortality(Up to 34 months)
- Time to first occurrence of ischemic stroke(Up to 34 months)
- Time to first occurrence of composite of ISTH major or clinically relevant non-major bleeding(Up to 34 months)
- Time to first occurrence of clinically relevant non-major bleeding(Up to 34 months)
- Time to first occurrence of hemorrhagic stroke(Up to 34 months)
- Time to first occurrence of intracranial hemorrhage(Up to 34 months)
- Time to first occurrence of fatal bleeding(Up to 34 months)
- Time to first occurrence of minor bleeding(Up to 34 months)
- Time to first occurrence of composite of stroke, systemic embolism, ISTH major bleeding, or all-cause mortality(Up to 34 months)
- Time to first occurrence of composite of disabling stroke (modified Rankin Scale (mRS) ≥ 3), critical bleeding, or all-cause mortality(Up to 34 months)