Eptifibatide Versus Abciximab in Primary PCI for Acute ST Elevation Myocardial Infarction
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 429
- 试验地点
- 1
- 主要终点
- Number of Participants With Complete Sum ST Resolution (STR) 60 Minutes (Min) After Percutaneous Coronary Intervention (PCI) (Per Protocol Population)
研究概览
简要总结
Multinational, multicentre, randomised, prospective, open, parallel group study directly comparing two glycoprotein-IIb/IIIa inhibitors, abciximab and eptifibatide, added early to standard treatment before primary PCI of STEMI patients with respect to effect on sum-ST-resolution after 60 minutes post-procedure and other measures of myocardial reperfusion
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Women must be postmenopausal (i.e.12 months without menstrual period), or surgically sterile, i.e. women of child bearing potential are not allowed to be included into the study. In cases of doubt a pregnancy test should be performed. (NB -post menopausal women currently receiving hormone replacement are permissible)
- •Acute myocardial infarction < 12 h defined as:
- •Angina or equivalent symptoms > 20 min and
- •ST elevation in 2 contiguous ECG leads (= 2 mm precordial lead, = 1 mm limb lead). This ECG recording serves as baseline ECG, i.e. ECG I.
- •Planned primary percutaneous coronary intervention
- •The subject has given written informed, dated consent to participate in the study
排除标准
- •Subjects not able to give informed consent
- •Left Bundle Branch Block
- •Thrombolytic therapy within 24 hours before randomization
- •Oral anticoagulation with International Normalized Ratio (INR) > 2
- •Known platelets < 100.000/µl or known hemorrhagic diathesis
- •Stroke or Transient Ischemic Attack (TIA) within the past 6 months or any permanent residual neurological defect
- •Evidence of an active gastrointestinal or urogenital bleeding
- •Major surgery within 6 weeks
- •History of allergic reaction to abciximab or eptifibatide or any component used in the study (including contrast media)
- •Known severe renal (creatinine clearance <30ml/min) or hepatic insufficiency as well as Alanine transaminase (ALT)/aspartate transaminase (AST) elevations = 3xUpper limit normal (ULN); isolated AST-elevation is not considered an exclusion criteria from study participation
- •Severe concomitant disease with life expectation < 1 year
- •Subject has participated in any study using an investigational drug or device within 30 days or within 5 half-lives of the investigational drug (whichever is longer) of entry into this study.
- •Subjects who will be inaccessible due to geographic or social factors during treatment or follow-up
- •In France, a subject is neither affiliated with nor a beneficiary of a social security category.
研究组 & 干预措施
Abciximab
Intravenous bolus of 0.25 mg/kg followed by continuous intravenous infusion of 0.125 mcg/kg/min (max. 10 mcg/min) for 12 h after PCI.
干预措施: Abciximab (Drug)
Eptifibatide
Intravenous bolus of 180 mcg/kg followed immediately by a continuous infusion of 2.0 mcg/kg/ min for 20-24 h after end of PCI, and a second bolus of 180 mcg/kg administered 10 min after the first bolus.
干预措施: Eptifibatide (Drug)
结局指标
主要结局
Number of Participants With Complete Sum ST Resolution (STR) 60 Minutes (Min) After Percutaneous Coronary Intervention (PCI) (Per Protocol Population)
时间窗: Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)
Sum STR was calculated as the difference between baseline (ECG I) and ECG III. The sum STR is the segment elevation resolution from all ECG leads associated with the infarct location. ST resolution, a method used to evaluate myocardial reperfusion, was expressed as a percentage of the baseline value (Complete: ≥ 70% resolution).
Number of Participants With Complete Sum ST Resolution (STR) 60 Min After Percutaneous Coronary Intervention (PCI) (Intent-to-Treat Population)
时间窗: Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III)
Sum STR was calculated as the difference between baseline (ECG I) and ECG III. The sum STR is the segment elevation resolution from all ECG leads associated with the infarct location. ST resolution, a method used to evaluate myocardial reperfusion, was expressed as a percentage of the baseline value (Complete: ≥ 70% resolution).
次要结局
- Number of Participants With Complete or Partial Sum ST Resolution (STR) 60 Min After PCI(Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III))
- Number of Participants With Complete Single Lead ST Resolution (STR) 60 Min After PCI(Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III))
- Mean Change From Baseline in the Sum ST Resolution 60 Min After PCI(Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III))
- Mean Change From Baseline in Single Lead ST Resolution (STR) 60 Min After PCI(Baseline (ECG I) and 60 min +/- 15 min after PCI (ECG III))
- Mean Change From Baseline in the Sum ST Resolution (STR) Before PCI(Baseline (ECG I) and immediately prior to PCI (ECG II))
- Mean Maximum ST Deviation Existing (Max STE) 60 Min After PCI(60 min +/- 15 min after PCI (ECG III))
- Number of Participants With the Indicated Patency of Infarcted Vessels According to Thrombolysis in Myocardial Infarction (TIMI) Classification Before PCI(immediately before PCI)
- Number of Participants With TIMI 3 Patency of Infarcted Vessels Following PCI(after PCI)
- Mean Number of Corrected TIMI Frame Counts (cTIMI) Following PCI(after PCI)
- Number of Participants With the Indicated Myocardial Blush Grade (TIMI Myocardial Perfusion Grade [TMPG]) After PCI(after PCI)
- Combined Endpoint: Number of Participants With Events of Death, Re-myocardial Infarction (MI), and Urgent Target Vessel Revascularisation (UTVR)(Day 7 or hospital discharge; Day 30 after index-MI)
- Number of Participants Who Died, and/or Experienced Re-MI and UTVR (Individually Counted)(Day 7 or hospital discharge; Day 30 after index-MI)
- Number of Participants Who Experienced Stroke or Major Bleeding Complications(Day 7 or hospital discharge; Day 30 after index-MI)
- Number of Participants Who Died and or Experienced Re-MI Until 6 Months After PCI(until 6 Month (Day 180) after index-MI)
- Number of Participants With Heart Failure Until 6 Months After PCI(until 6 Months (Day 180) after index-MI)
- Number of Participants With Major Bleedings (TIMI Classification)(Day 7 or hospital discharge; Day 30 after index-MI)
- Number of Participants With Minor Bleedings (TIMI Classification)(Day 7 or hospital discharge; Day 30 after index-MI)
- Mean Duration of Stay in the Ward(until 6 months after index-MI)