Long-term, Open-label Follow-up Treatment of Patients With Atrial Fibrillation Who Have Been Previously Treated With BIBR 1048 in the PETRO Trial (Trial 1160.20 - NCT01227629). (PETRO Extension Trial: PETRO-Ex)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 361
- 试验地点
- 50
- 主要终点
- Yearly Event Rate for Major Bleeding
研究概览
简要总结
To determine the long term safety and efficacy of BIBR 1048 in patients with chronic atrial fibrilla tion, with or without concomitant chronic treatment with acetylsalicylic acid (ASA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Prevention
- 盲法
- None
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
- •previous treatment with BIBR 1048 in PETRO (trial 1160.20- NCT01227629) and no premature discontinuation of therapy
- •paroxysmal, persistent, or permanent (chronic) non-rheumatic atrial fibrillation, documented by electrocardiogram (ECG) at least twice prior to enrollment in PETRO
- •concomitant coronary artery disease -an additional risk factor for stroke (one or more of the following conditions/events): hypertension, diabetes mellitus (DM), congestive heart failure (CHF) or Left ventricular dysfunction (LVD), previous ischemic stroke or transient ischemic attack) TIA, or age greater than 75 years. -age >= 18 years
- •written, informed consent
- •Exclusion criteria
排除标准
- •Valvular heart disease conferring significantly increased risk of thromboembolic events (e.g. clinically significant mitral stenosis or prosthetic valves). planned cardioversion while patients are in the study.
- •contraindication to anticoagulant therapy (previous intracranial hemorrhage, gastro-intestinal (GI) hemorrhage within previous 3 months, previous severe hemorrhage with warfarin at therapeutic international normalized ratio (INR), regular use of non-steroidal anti-inflammatory drugs, hemorrhagic diathesis) major bleeding within the last 6 months (other than GI hemorrhage).
- •severe renal impairment (estimated glomerular filtration rate [GFR] <= 30 mL/min). uncontrolled hypertension (systolic blood pressure [SBP] > 180 mm Hg and/or diastolic blood pressure [DBP] > 100 mmHg).
- •Women who are pregnant or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study (note: a negative pregnancy test must be obtained for any woman of childbearing potential prior to entry into the study).
- •Patients who have received an investigational drug other than BIBR 1048 within the last 30 days.
- •Patients considered unreliable by the investigator concerning the requirements for follow-up during the study and/or compliance with study drug administration. Another indication for anticoagulant treatment (eg, deep vein thrombosis or pulmonary embolus). Clinically significant anemia (note: patients with mild-moderate anemia should only be enrolled after the possibility of a GI bleeding source has been evaluated, the etiology of the anemia identified, and appropriate action taken). Patients suffering from thrombocytopenia (platelets < 100,000/uL). Any other condition which, in the discretion of the investigator, would not allow safe participation in the study.
- •Continuing or planned concomitant treatment with antiplatelet agents other than acetylsalicylic acid (ASA).
- •Recent malignancy or radiation therapy (<= 6 months).
研究组 & 干预措施
dabigatran etexilate, 150 mg once daily
dosage used at study start
干预措施: dabigatran etexilate (Drug)
dabigatran etexilate, 150 mg twice daily
dosage used at study start
干预措施: dabigatran etexilate (Drug)
dabigatran etexilate, 300 mg once daily
dosage used at study start
干预措施: dabigatran etexilate (Drug)
dabigatran etexilate, 300 mg twice daily
dosage used at study start
干预措施: dabigatran etexilate (Drug)
结局指标
主要结局
Yearly Event Rate for Major Bleeding
时间窗: 5 years
Time to first occurrence of fatal or life-threatening, retroperitoneal, intracranial, intraocular, or intraspinal bleeding, which required surgical treatment, led to a transfusion of a minimum of 2 units of packed cells or whole blood, or led to a fall in hemoglobin of 20g/L or less. Yearly event rate (%) = number of subjects with event / subject-years \* 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Yearly Event Rate for Composite Endpoint of Stroke, Transient Ischaemic Attacks, System Thromboembolism, Myocardial Infarction, Other Major Adverse Cardiac Events and Mortality.
时间窗: 5 years
Time to first occurrence of stroke, transient ischaemic attacks, system thromboembolism, myocardial infarction, other major adverse cardiac events and mortality. Yearly event rate (%) = number of subjects with event / subject-years \* 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Yearly Event Rate for Major + Minor/Relevant Bleeding
时间窗: 5 years
Time to first occurrence of either major or minor/relevant bleeding. Yearly event rate (%) = number of subjects with event / subject-years \* 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Yearly Event Rate for Any Bleeding
时间窗: 5 years
Time to first occurrence of any bleeding event. Yearly event rate (%) = number of subjects with event / subject-years \* 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
Yearly Event Rate for Minor Bleeding
时间窗: 5 years
Time to first occurrence of minor bleeding. A minor bleeding event is any bleed that does not qualify as a major bleed. All minor bleeding events not fulfilling one of the criteria for clinically relevant were classified as nuisance bleeds. Clinically-relevant was defined as spontaneous skin hematoma ≥25 cm², spontaneous nose bleed \>5 min, macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention, spontaneous rectal bleeding, gingival bleeding \>5 min, leading to hospitalization, leading to a transfusion of \<2 units of packed cells or whole blood and any other bleeding event considered clinically relevant by the investigator. Yearly event rate (%) = number of subjects with event / subject-years \* 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
次要结局
- Yearly Event Rate for Stroke(5 years)
- Yearly Event Rate of Ischaemic Stroke(5 years)
- Yearly Event Rate of Haemorrhagic Stroke(5 years)
- Yearly Event Rate for Transient Ischaemic Attacks(5 years)
- Yearly Event Rate for Systemic Thromboembolism(5 years)
- Yearly Event Rate of Myocardial Infarction(5 years)
- Yearly Event Rate of Other Major Adverse Cardiac Events(5 years)
- Yearly Event Rate of Death(5 years)
- Yearly Event Rate for Composite Secondary Endpoint of Ischaemic Stroke, Transient Ischaemic Attacks, Non-central Nervous System Systemic Thromboembolism, Myocardial Infarction, Other Major Adverse Cardiac Events and All-cause Mortality(5 years)
- Severe Adverse Event(5 years)
- Laboratory Analyses(5 years)