EUCTR2006-000303-42-BE进行中（未招募）1 期
Ongoing 2b/3a inhibition In Myocardial infarction EvaluationA Randomized, Double Blind Controlled Trial Evaluating the Benefits of Early Up-Front-loaded High Dose Tirofiban in the Treatment of Patients with ST-segment Elevation Myocardial Infarction, who are Candidates for Primary Angioplasty - On-TIME 2
Diagram B.V.0 个研究点目标入组 985 人开始时间: 2007年5月9日最近更新:
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
- 985
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. Males or females > 21 years of age and < 85 years with symptoms of acute myocardial infarction of more than 30 minutes but less than 24 hours.
- •2. ST segment elevation of > 1 mV in 2 adjacent ECG leads, with cumulative ST segment deviation of 6 mm or more.
- •3. Patients should only be included if there is a reasonable expectation that PCI will be conducted within 2 hours.
- •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) Patients who are unable to give informed consent or have life expectancy of < 1year
- •2) Patient is pregnant or breastfeeding
- •3) Patients with left bundle branch block
- •4) Subject who have received thrombolytic therapy within 24 hours or warfarin in last 7 days or another GpIIb/IIIa within last 30 days
- •5) Subject who have known severe renal dysfunction (GFR<30ml/min or serum creatinine >2.5 mg/dl or 200mmmol/l) or receiving dialysis or previously undertaken renal transplantation
- •6) Confirmed or persistent severe hypertension (Systolic b.p. > 180 mmHg and/or diastolic b.p. >110 mmHg) at randomization
- •7) Subjects with a contraindication to anticoagulation or at increased bleeding risk
- •a. Past or present history (<1 year) of bleeding from gastrointestinal (haematemesis) malena, frank bleed in stool or visible haematuria
- •b. Known thrombocytopenia, platelet count (<100,00/mm3 ) or coagulopathy or platelet disorder
- •c. History of hemorrhagic TIA, CVA (last 6 months), intracranial pathology (neoplasm, aneurysm, AV malformation)
- •d. History of major recent (<30 day) surgery or trauma
- •e. Known presence of retinopathy or pericarditis or recent epidural procedure
- •8) Patients who have received another investigational drug or device or participated in any clinical trial within 4 weeks prior to randomization
- •9) Patients in cardiogenic shock (SBP ,80mmHg for >30 mins) or needing IABP
- •10) Known Hb <11gm/dl or HCT <33%
- •11) Hypersensitivity to any component of Tirofiban or ASA or Heparin or clopidogrel
研究者
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