NCT00206063终止2 期
Long-Term Treatment With the Oral Direct Thrombin Inhibitor Ximelagatran, Compared to Warfarin, as Stroke Prophylaxis in Patients With Atrial Fibrillation. A Long Term Follow-Up Study
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 220
- 试验地点
- 19
- 主要终点
- Number of Adverse Events, with special regard to bleeding, thromboembolic events and discontinuation of treatment.
研究概览
简要总结
The purpose of this study is to evaluate tolerability of long-term treatment with ximelagatran compared to standard treatment with warfarin.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Signed informed consent.
- •Completion of the study SH-TPA-0002, history of chronic atrial fibrillation (i.e. rapidly beating heart), at least one risk factor for stroke (e.g. high blood pressure, age over 65, previous stroke or similar attack, diabetes or coronary heart disease)
排除标准
- •Conditions associated with increased risk of bleeding, renal impairment, known active liver disease or liver insufficiency
结局指标
主要结局
Number of Adverse Events, with special regard to bleeding, thromboembolic events and discontinuation of treatment.
次要结局
未报告次要终点
研究者
研究点 (19)
Loading locations...
相似试验
已完成
2 期
Long-term Safety in Atrial Fibrillation PatientsPersistent or Permanent Nonvalvular Atrial FibrillationNCT00645853AstraZeneca523
进行中（未招募）
不适用
ong-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 studyEUCTR2007-001722-27-HUAstraZeneca AB600
进行中（未招募）
不适用
ong-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 studyParoxysmal persistent or permanent non-valvular atrial fibrillationMedDRA version: 9.1Level: LLTClassification code 10003658Term: Atrial fibrillationEUCTR2007-001722-27-DKAstraZeneca AB600
进行中（未招募）
不适用
ong-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 studyMedDRA version: 9.1Level: LLTClassification code 10003658Term: Atrial fibrillationParoxysmal persistent or permanent non-valvular atrial fibrillationEUCTR2007-001722-27-SEAstraZeneca AB600
进行中（未招募）
不适用
ong-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 studyParoxysmal persistent or permanent non-valvular atrial fibrillationMedDRA version: 9.1Level: LLTClassification code 10003658Term: Atrial fibrillationEUCTR2007-001722-27-ATAstraZeneca AB600