EUCTR2008-005248-17-IT进行中（未招募）不适用
RELY-ABLE long term multi-center extension of dabigatran treatment in patients with atrial fibrillation who completed the RE-LY trial and a cluster randomised trial to assess the effect of a knowledge translation intervention on patient outcomes - RELY-ABLE
BOEHRINGER ING.0 个研究点目标入组 8,000 人开始时间: 2008年12月19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 perform a pulmonary vein ablation or surgery for cure of AF 3. Patients with prosthetic heart valves requiring anticoagulation differing from an INR of 2.0?3.0 4. Symptomatic or endoscopically documented gastroduodenal ulcer disease in the 30 days prior to the start of this trial 5. Severe renal impairment (estimated creatinine clearance <=30 mL/min) based upon last results available from RE-LY 1160.26 (should be from within the past year) 6. Anaemia (haemoglobin <100g/L) or thrombocytopenia (platelet count <100 x 109/L) based upon last results available from RE-LY 1160.26 (should be from within the past year). 7. Uncontrolled hypertension (SBP >180 mmHg and/or DBP >100 mmHg) 8. Active liver disease, including known hepatitis A, B or C 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. Patients considered unreliable by the investigator concerning the requirements for follow-up during the study and/or compliance with study drug administration (i.e., demonstrated study drug compliance of less than 80% in RE-LY or was noncompliant with study visits in RE-LY), or has any condition which in the opinion of the investigator would not allow safe participation in the study (e.g., drug addiction, alcohol abuse). 13. Current use of quinidine
研究者
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