NCT00645853已完成2 期
Long-term Treatment With the Oral Direct Thrombin Inhibitor AZD0837, Compared to Vitamin-K Antagonists, as Stroke Prevention in Patients With Non-valvular Atrial Fibrillation and One or More Risk Factors for Stroke and Systemic Embolic Events. A 5-year Follow-up Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 523
- 主要终点
- Bleeding: Number of Patients With Any Bleeding Event, During Treatment Period
研究概览
简要总结
The purpose of this study is to provide safety and tolerability data for AZD0837 during long-term treatment (5 years) in patients with non-valvular atrial fibrillation (AF) and one or more additional risk factors for stroke and systemic embolic events (moderate to high risk patients).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with paroxysmal, persistent or permanent Non Valvular Atrial Fibrillation with one or more additional risk factors for stroke and systemic embolic event
- •completing treatment with study drug in D1250C00008.
排除标准
- •Atrial Fibrillation secondary to reversible disorders, eg hyperthyroidism
- •Presence of a valvular heart disease, mechanical heart valves, active endocarditis, left ventricular aneurysm or thrombus, atrial myxoma or any condition other than Atrial Fibrillation requiring chronic anticoagulation treatment
- •Myocardial infarction, heart surgery or percutaneous coronary intervention (PCI) within the previous three months prior to inclusion; Stroke and/or systemic embolism within the previous 30 days prior to inclusion
- •Conditions associated with increased risk of major bleeding.
研究组 & 干预措施
1
Experimental
干预措施: AZD0837 (Drug)
2
Active Comparator
干预措施: VKA INR 2-3 (Drug)
结局指标
主要结局
Bleeding: Number of Patients With Any Bleeding Event, During Treatment Period
时间窗: 154-711 days on treatment
Participants
次要结局
- Alanine Transaminase (ALAT): Number of Patients With ALAT>=3xULN, Post Baseline(From baseline to Follow up)
- Bilirubin: Number of Patients With Bilirubin>=2xULN, Post Baseline(From baseline to Follow up)
- Creatinine: Absolute Change From Baseline, at End of Treatment(Baseline and End of treatment)
- D-dimer:Median and Quartile Range at End of Treatment(End of treatment)
- Activated Partial Thromboplastin Time (APTT): Absolute Change From Baseline to End of Treatment(Baseline and End of treatment)
- Electroconvulsive Therapy (ECT): Absolute Change From Baseline to End of Treatment(Baseline and End of Treatment)
- AZD0837: Plasma Concentration of AZD0837 at End of Treatment(End of treatment)
- AR-H067637XX, the Active Major Metabolite of AD0837: Plasma Concentration of AR-H067637XX, at End of Treatment(154-711 days on treatment)
研究者
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