EUCTR2009-014343-36-DE进行中（未招募）不适用
RANDOMIZED TRIAL OF PRASUGREL PLUS BIVALIRUDIN VERSUS CLOPIDOGREL PLUS HEPARIN IN PATIENTS WITH ACUTE STEMI BAVARIAN REPERFUSION ALTERNATIVES EVALUATION [BRAVE-4] TRIAL - BRAVE-4
Deutsches Herzzentrum0 个研究点目标入组 1,240 人开始时间: 2009年8月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,240
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.Patients presenting within 24 hours from the onset of symptoms, with chest pain lasting = 20 minutes and with = 0.1 mV of ST-segment elevation in = 2 adjacent limb leads or = 0.2 mV in = 2 contiguous precordial leads or new left bundle branch block on surface ECG
- •2.Informed, written consent
- •3.In women with childbearing potential a pregnancy test is obligatory.
- •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
- •1.Patients presenting within 24 hours from the onset of symptoms, with chest pain lasting = 20 minutes and with = 0.1 mV of ST-segment elevation in = 2 adjacent limb leads or = 0.2 mV in = 2 contiguous precordial leads or new left bundle branch block on surface ECG
- •2.Informed, written consent
- •3.In women with childbearing potential a pregnancy test is obligatory.
- •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.Age < 18 years
- •2. Cardiogenic shock or prolonged cardio-pulmonary resuscitation
- •3.Active bleeding; bleeding diathesis; coagulopathy
- •4.History of gastrointestinal or genitourinary bleeding within the previous 2 months
- •5.Refusal to receive blood transfusion
- •6.Major surgery in the last 6 weeks
- •7.History of intracranial bleeding or structural abnormalities (intracerebral mass, aneurysm, arteriovenous malformation)
- •8.Suspected aortic dissection;
- •9. TIA within the last two weeks
- •10.Heparin-induced thrombocytopenia
- •11.Any previous stroke
- •12.Prior administration of thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux for the index MI
- •13.Known relevant hematological deviations:
- •hemoglobin < 100 g/l
- •platelet count < 100 x 109 cells/l
- •14.Use of coumadin derivatives within the last 7 days
- •15.Chronic therapy with nonsteroidal anti-inflammatory drugs (except aspirin), cyclooxygenase-2 inhibitors, prasugrel.
- •16.Known malignancies or other comorbid conditions with life expectancy less than one year that may result in protocol non-compliance
- •17.Known severe liver disease
- •18.Known severe renal failure with GFR <30 ml/min and/or dialysis
- •19.Known allergy to the study medications
- •20.Previous enrollment in this trial
- •21.Women who are known to be pregnant, who are of childbearing potential and test positive for pregnancy, who have given birth within the last 90 days, who are breastfeeding.
- •22.Patient’s inability to fully cooperate with the study protocol
- •1.Age < 18 years
- •2. Cardiogenic shock or prolonged cardio-pulmonary resuscitation
- •3.Active bleeding; bleeding diathesis; coagulopathy
- •4.History of gastrointestinal or genitourinary bleeding within the previous 2 months
- •5.Refusal to receive blood transfusion
- •6.Major surgery in the last 6 weeks
- •7.History of intracranial bleeding or structural abnormalities (intracerebral mass, aneurysm, arteriovenous malformation)
- •8.Suspected aortic dissection;
- •9. TIA within the last two weeks
- •10.Heparin-induced thrombocytopenia
- •11.Any previous stroke
- •12.Prior administration of thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux for the index MI
- •13.Known relevant hematological deviations:
- •hemoglobin < 100 g/l
- •platelet count < 100 x 109 cells/l
- •14.Use of coumadin derivatives within the last 7 days
- •15.Chronic therapy with nonsteroidal anti-inflammatory drugs (except aspirin), cyclooxygenase-2 inhibitors, prasugrel.
- •16.Known malignancies or other comorbid conditions with life expectancy less than one year that may result in protocol non-compliance
- •17.Known severe liver disease
- •18.Known severe renal failure with GFR <30 ml/min and/or dialysis
- •19.Known allergy to the study medications
- •20.Previous enrollment in this trial
- •21.Women who are known to be pregnant, who are of childbearing potential and test positive for pregnancy, who have given birth within the last 90 days, who are breastfeeding.
- •22.Patient’s inability to fully cooperate with the study protocol
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