Dose Exploration in Patients With Atrial Fibrillation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 502
- 试验地点
- 38
- 主要终点
- Number of Participants With Fatal or Life-threatening Major Bleeding Events
研究概览
简要总结
The purpose of this trial is to evaluate the safety of different doses of BIBR 1048, alone or in combination with acetylsalicylic acid (ASA), as determined by the rates of bleeding and other adverse events.
A secondary objective of this trial is to evaluate the anticoagulant effect of different doses of BIBR 1048, based on the reduction of plasma concentrations of D-dimer, a laboratory marker for activated coagulation in patients with atrial fibrillation (AF), and to correlate bleeding and other events with pharmacokinetic (PK) and pharmacodynamic (PD) data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
dabigatran 50 mg twice daily (bid)
Dabigatran: one capsule in the morning and 1 capsule in the evening. Twice daily (bis in die = bid).
干预措施: dabigatran without ASA (Drug)
dabigatran 50 mg bid + 81 mg ASA qd
Dabigatran: one capsule in the morning and 1 capsule in the evening. Acetylsalicylic acid (ASA) once daily (quaque dies = qd) in the morning.
干预措施: dabigatran with ASA (Drug)
dabigatran 50 mg bid + 325 mg ASA qd
Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning
干预措施: dabigatran with ASA (Drug)
dabigatran 150 mg bid
Dabigatran: one capsule in the morning and 1 capsule in the evening
干预措施: dabigatran without ASA (Drug)
dabigatran 150 mg bid + 81 mg ASA qd
Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning
干预措施: dabigatran with ASA (Drug)
dabigatran 150 mg bid + 325 mg ASA qd
Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning
干预措施: dabigatran with ASA (Drug)
dabigatran 300 mg bid
Dabigatran: one capsule in the morning and 1 capsule in the evening
干预措施: dabigatran without ASA (Drug)
dabigatran 300 mg bid + 81 mg ASA qd
Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning
干预措施: dabigatran with ASA (Drug)
dabigatran 300 mg bid + 325 mg ASA qd
Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning
干预措施: dabigatran with ASA (Drug)
warfarin
once daily, dosed to target International Normalised Ratio (INR) 2.0 to 3.0
干预措施: warfarin (Drug)
结局指标
主要结局
Number of Participants With Fatal or Life-threatening Major Bleeding Events
时间窗: 12 weeks
Retroperitoneal, intracranial, intraocular, or intraspinal bleeding, or requiring surgical treatment, or leading to a transfusion of 2 units or more, or leading to a fall in hemoglobin of 20g/L or more
Number of Participants With Minor/Relevant Bleeding Events
时间窗: 12 weeks
Haematuria, rectal bleeding, gingival bleeding, skin hematoma of 25cm\^2 or more, nose bleed of more than 5 minutes duration, bleeding leading to a hospitalization, leading to a transfusion of less than 2 units or any other clinically relevant bleeding
Number of Participants With Minor/Nuisance Bleeding Events
时间窗: 12 weeks
All bleeding events not fulfilling one of the criteria for major bleeding event or minor/relevant bleeding events.
次要结局
- Ecarin Clotting Time (ECT): Difference From Baseline(baseline and 12 weeks)
- Activated Partial Thromboplastin Time (aPTT): Difference From Baseline(baseline and 12 weeks)
- Number of Participants With Thromboembolic Events: Composite Endpoint(12 weeks)
- Thromboembolic Events: Number of Participants With Transient Ischemic Attack(12 weeks)
- Number of Participants With Thromboembolic Events: Ischemic Stroke(12 weeks)
- Trough Plasma Concentration of Dabigatran (BIBR 953)(12 weeks)
- Number of Participants With Increase of Aspartat-Aminotransferase (AST) to >2*Baseline(12 weeks)
- Thromboembolic Events: Number of Participants With Systemic Thromboembolism(12 weeks)
- Thromboembolic Events: Number of Participants With Myocardial Infarction(12 weeks)
- Thromboembolic Events: Number of Participants With Other Major Cardiac Events(12 weeks)
- Thromboembolic Events: Number of Participants Who Died(12 weeks)
- D-dimer: Difference From Baseline(baseline and 12 weeks)
- Soluble Fibrin: Difference From Baseline(baseline and 12 weeks)
- 11-dehydrothromboxane B2 (TXB2): Difference From Baseline(baseline and 12 weeks)
- Number of Participants With Increase of Alkaline Phosphatase (AP) to >2*Baseline(12 weeks)
- Number of Participants With Increase of Bilirubin to >2*Baseline(12 weeks)
- Number of Participants With Increase of Alanine-Aminotransferase (ALT) to >2*Baseline(12 weeks)
- Severity of Adverse Events(12 weeks)