JPRN-jRCT2061220080已完成3 期
multicenter, international, randomized, active comparator-controlled, doubleblind, 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 - OCEANIC-AF
Myoishi Masashi0 个研究点目标入组 18,000 人开始时间: 2022年12月29日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 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,
- •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 AF
研究者
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