EUCTR2010-023779-24-NL进行中（未招募）不适用
A Comparison of Drug Eluting and Bare Metal Stents with Bivalirudin during PCI or Bivalirudin for 4 hours in Acute Coronary Syndromes. The Eindhoven Reperfusion Study - The DEBATER 2 Trial
Stichting Toegepast Caridologisch Onderzoek0 个研究点目标入组 1,800 人开始时间: 2010年11月11日最近更新:
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
- 1,800
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
- •STEMI < 12 hours (or STE equivalent), or NSTEMI < 48 hours
- •No contraindications for PCI
- •No contraindications for abciximab
- •No contraindications for clopidogrel
- •Informed consent from the patient
- •Criteria for STEMI < 12 hours (or STE equivalent)
- •Continual chest discomfort of acute onset within the last 12 hours
- •= 1 mm ST-segment elevation in = 2 contiguous ECG leads
- •STE equivalent
- •= 1 mm ST-segment depression in ECG leads V1-V3 (reversed ST-segment elevations of the posterior wall)
- •New left bundle branch block (LBBB)
- •Old LBBB or paced rhythm with:
- •ST-segment elevation > 5 mm in right precordial leads V1-V3 (discordant with QRS)
- •ST-segment depression/T wave inversion V1-V3
- •ST-segment elevation = 1 mm concordant with a large R wave
- •Criteria for high-risk NSTEMI
- •Patients with recurrent ischemia/chest pain
- •Dynamic ECG changes (ST-segment depression or transient ST-segment elevation)
- •Elevated troponin levels
- •Early post infarction unstable angina
- •Hemodynamic instability
- •Major arrhythmias (VF, VT)
- •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
- •Contraindication for PCI: peripheral/coronary artery disease that is inaccessible for PCI
- •Contraindication for GPI: ongoing bleeding, bleeding diathesis, cerebrovascular accident in the last 6 months, major surgery/trauma in the last 6 months, platelet count < 100.000 mm3, intracranial intravenous malformation or neoplasm, malignant hypertension, INR . 1.5, severe hepatic dysfunction
- •Contraindication for bivalirudin: bleeding diathesis, thrombocytopathy, thrombocytopenia, coagulopathy, recent surgery, TIA or CVA, severe uncontrolled hypertension, active peptic ulcer, severe renal insufficiency (MDRD < 30 ml/min).
- •Contraindication for clopidogrel: severe hepatic dysfunction, pathological bleeding
- •disorders such as peptic ulcer or intracranial bleeding
- •Thrombolytic therapy within the last 24 hours
- •Therapy with GPI within the last 24 hours
- •Anticoagulation therapy
- •C-morbid conditions with a predictable fatal outcome in the short run
- •No informed consent: refusal, (sub) coma, artificial respiration, impaired mentation
- •Patients who are already included in DEBATER II or in other trials
研究者
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