Open Label, Randomised Exploratory Dose Response Study in Pharmacodynamics and Safety of BIBR 1048 (110 mg Twice Daily (b.i.d.) and 150 mg b.i.d.) for 12 Weeks in Patients With Non-valvular Atrial Fibrillation in Comparison to Warfarin
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 28
- 主要终点
- Incidence and Severity of Adverse Events
研究概览
简要总结
The primary objective was to evaluate the safety of dabigatran etexilate(BIBR 1048) administered orally at doses of 110 and 150 mg, twice daily, for 12 weeks in patients with non-valvular atrial fibrillation (paroxysmal, persistent or permanent) in comparison 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
- 20 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 etexilate 220 mg daily
Dabigatran etexilate 110 mg capsule, twice a day, oral administration
干预措施: Dabigatran etexilate (Drug)
Dabigatran etexilate 300 mg daily
Dabigatran etexilate 150 mg capsule, twice a day, oral administration
干预措施: Dabigatran etexilate (Drug)
Warfarin
Dose-adjusted warfarin based on target INR values
干预措施: Warfarin (Drug)
结局指标
主要结局
Incidence and Severity of Adverse Events
时间窗: Upto 15 weeks
Intensity of event is categorised as mild, moderate and severe.
Discontinuation of the Study Drug Due to Adverse Events
时间窗: Upto 15 weeks
Discontinuation of the study drug due to adverse events.
Changes in Laboratory Test Values
时间窗: 12 weeks
The number of patients with ALT, AST, alkaline phosphatase, or bilirubin exceeded the upper limit of normal (ULN) range
Frequency (Occurrence Rates) of Major Bleeding Event
时间窗: upto 15 weeks
The percentage of patients with major bleeding event. Major bleeding was defined as any bleed fulfilling one of the following conditions: * Fatal or life-threatening * Retroperitoneal, intracranial, intraocular, or intraspinal bleeding (verified by objective testing) * Bleeding requiring surgical treatment * Clinically overt bleeding leading to a transfusion (erythrocyte component transfusion or whole blood transfusion) of 4.5 units (equal to 2 units in EU/US) or more * Clinically overt bleeding leading to a fall in haemoglobin of at least 2 g/dL
Frequency (Occurrence Rates) of Clinically Relevant Bleeding Event
时间窗: upto 15 weeks
The percentage of patients with clinically relevant bleeding event. Any bleed that did not qualify as a major bleed was defined as a minor bleed; minor bleed which fulfilled one of the criteria below was defined as a clinically relevant bleeding event: * A skin haematoma of at least 25 sqcm * Spontaneous nose bleed lasting for more than 5 minutes * Macroscopic haematuria (either spontaneous or, if associated with an intervention, lasting more than 24 hours) * Spontaneous rectal bleeding (more than spotting on toilet paper) * Gingival bleeding lasting for more than 5 minutes * Bleeding leading to hospitalisation * Bleeding leading to blood transfusion (erythrocyte component transfusion or whole blood transfusion) of less than 4.5 units (equal to 2 units in EU/US) * Any other bleeding considered clinically relevant by the investigator
Frequency (Occurrence Rates) of Nuisance Bleeding Event
时间窗: Upto 15 weeks
The percentage of patients with nuisance bleeding event Any bleed that did not qualify as a major bleed was defined as a minor bleed; all minor bleeding events not fulfilling one of the criteria below was defined as a nuisance bleeding event: * A skin haematoma of at least 25 sqcm * Spontaneous nose bleed lasting for more than 5 minutes * Macroscopic haematuria (either spontaneous or, if associated with an intervention, lasting more than 24 hours) * Spontaneous rectal bleeding (more than spotting on toilet paper) * Gingival bleeding lasting for more than 5 minutes * Bleeding leading to hospitalisation * Bleeding leading to blood transfusion (erythrocyte component transfusion or whole blood transfusion) of less than 4.5 units (equal to 2 units in EU/US) * Any other bleeding considered clinically relevant by the investigator
次要结局
- Frequency (Occurrence Rates) of a Composite Clinical Endpoint.(Upto 15 weeks)
- Frequency (Occurrence Rates) of Ischemic or Haemorrhagic Stroke (Fatal or Non-fatal)(Upto 15 weeks)
- Frequency (Occurrence Rates) of Transient Ischemic Attack(Upto 15 weeks)
- Frequency (Occurrence Rates) of Systemic Embolism(Upto 15 weeks)
- Frequency (Occurrence Rates) of Myocardial Infarction (Fatal or Non-fatal)(Upto 15 weeks)
- Frequency (Occurrence Rates) of Other Major Adverse Cardiac Events(Upto 15 weeks)
- Frequency (Occurrence Rates) of Death(Upto 15 weeks)
- Anticoagulation Effects Trough aPTT (Activated Partial Thromboplastin Time)(Week 0,1,4 and 12)
- Anticoagulation Effects Trough ECT (Ecarin Clotting Time)(Week 0,1,4 and 12)
- Anticoagulation Effects Trough INR (International Normalised Ratio)(Week 0,1,4 and 12)
- Anticoagulation Effects Trough 11-dehydrothromboxane B2(Week 0 and 12)
- Steady-state Pharmacokinetics of Total Dabigatran Trough Plasma Concentration(Week 1,4 and 12)