EUCTR2007-007864-63-DE进行中(未招募)1 期
Prospective, randomized and controlled clinical trial comparing i.v. bolus application of Abciximab to i.c.application of Abciximab during primary PCU in patients with acute ST-elevation myocardial infarction - Abciximab-STEMI
niversity of Leipzig0 个研究点目标入组 2,065 人开始时间: 2008年2月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 2,065
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) >= 18 years of age
- •2) ST-elevation myocardial infarction, characterized by:
- •a)Clinical symptoms:
- •Angina pectoris < 12 hours and
- •Persistent angina > 30 minutes
- •b) ECG-criteria in 12-lead ECG:
- •ST-segment elevation > 1mm in = 2 extremity leads and / or
- •ST-segment elevation > 2mm in = 2 adjacent precordial leads
- •3) written informed consent
- •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)Known drug hypersensitivity to Abciximab, other components of the trial medication or murine monoclonal antibodies
- •2)Known drug hypersensitivity to ASS or heparin
- •3)Active peptic ulcus ventriculi or duodeni
- •4)Major surgical interventions, lithotripsy, intracranial / intraspinal interventions or puncture of a not sufficiently compressible vessel less than eight weeks before start of trial
- •5)Intracranial tumors
- •6)Active internal bleeding
- •7)Cerebrovascular complications less than 2 years befor start of trial
- •8)Known coagulation defect or thrombocytopenia
- •9)Arteriovenous malformations or aneurysm
- •10)Severe liver or renal insufficiency (creatinin clearence < 30 ml/min)
- •11)Uncontrolled hypertension, hypertensive retinopathy
- •12)Vasculitis
- •13)Previous thrombolysis (less than 12 hrs ago)
- •14)Lacking compliance
- •15) Pregnant or nursing women
- •16) Fertile female patients (< 2 years post their last menstruation) without using appropriate contraception (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner) during trial participation
- •17)Participation in another interventional trial
- •Additional exclusion criteria for the MRT substudy:
- •1) Severe claustrophobia
- •2) Hemodynamic instability
- •3) Pacemaker or internal cardioverter defibrillator (ICD)
- •4) Metallic cerebral or intracranial implants
- •5) Known frug hypersensitivity to Gadolinium
研究者
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