CTRI/2009/091/000026已完成3 期
ong 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.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 261
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
入选标准
- •Patients are eligible for this study if they meet the following criteria:
- •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
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
相似试验
已完成
3 期
RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed RE-LY TrialAtrial FibrillationNCT00808067Boehringer Ingelheim5,897
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-ABLEMedDRA version: 9.1Level: LLTClassification code 10003658Term: Atrial fibrillationThis is a study of the long term safety of dabigatran (intended indication: stroke prevention in patients with atrial fibrillation).Eligible patients received dabigatran during the RE-LY trial 1160.26.At the time of entry into RE-LY, patients had at least one risk factor for stroke (1) congestive heart failure, 2) left ventricular dysfunction, 3) age >75, 4) age >65 years with hypertension, diabetes or coronary artery disease or 5) previous stroke, systemic embolism or transient ischemic attack)EUCTR2008-005248-17-PTBoehringer Ingelheim Inc.8,000
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-ABLEThis is a study of the long term safety of dabigatran (intended indication: stroke prevention in patients with atrial fibrillation).Eligible patients received dabigatran during the RE-LY trial 1160.26.At the time of entry into RE-LY, patients had at least one risk factor for stroke (1) congestive heart failure, 2) left ventricular dysfunction, 3) age >75, 4) age >65 years with hypertension, diabetes or coronary artery disease or 5) previous stroke, systemic embolism or transient ischemic attack)MedDRA version: 9.1Level: LLTClassification code 10003658Term: Atrial fibrillationEUCTR2008-005248-17-HUBoehringer Ingelheim RCV GmbH & Co KG8,000
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-ABLEStroke prevention in patients with atrial fibrillationMedDRA version: 9.1Level: LLTClassification code 10003658Term: Atrial fibrillationEUCTR2008-005248-17-ITBOEHRINGER ING.8,000
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-ABLEThis is a study of the long term safety of dabigatran (intended indication: stroke prevention in patients with atrial fibrillation).Eligible patients received dabigatran during the RE-LY trial 1160.26.At the time of entry into RE-LY, patients had at least one risk factor for stroke (1) congestive heart failure, 2) left ventricular dysfunction, 3) age >75, 4) age >65 years with hypertension, diabetes or coronary artery disease or 5) previous stroke, systemic embolism or transient ischemic attack)MedDRA version: 9.1Level: LLTClassification code 10003658Term: Atrial fibrillationEUCTR2008-005248-17-FIBoehringer Ingelheim Finland Ky8,000