EUCTR2008-005248-17-PT进行中（未招募）不适用
RELY-ABLE long term multi-center extension of dabigatran treatmentin patients with atrial fibrillation who completed the RE-LY trial and acluster randomised trial to assess the effect of a knowledge translationintervention on patient outcomes - RELY-ABLE
Boehringer Ingelheim Inc.0 个研究点目标入组 8,000 人开始时间: 2008年12月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 8,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Randomization to dabigatran in RE-LY and not permanently discontinued from dabigatran at the time of RE-LY termination visit
- •2. Patient must require long-term treatment with oral anticoagulation and investigator determines it is clinically appropriate for patient to continue receiving oral anticoagulation.
- •3. Written, informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Need for anticoagulant treatment for disorders other than atrial fibrillation
- •2. Plan to cure of AF
- •3. Patients with prosthetic heart valves
- •4. gastroduodenal ulcer disease
- •5. Severe renal impairment
- •6. Anaemia or thrombocytopenia
- •7. Uncontrolled hypertension
- •8. Active liver disease
- •9. Active infective endocarditis
- •10. Women who are pregnant, lactating or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study
- •11. Patients who have received an investigational drug other than dabigatran in the past 30 days or are participating in another drug study.
- •12. Other reasons for which Investigator determines patient icannot safely participate
- •13. Current use of quinidine
研究者
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