NCT00440778已完成4 期
A Randomized Trial of Early Discharge After Trans-radial Stenting of Coronary Arteries in Acute Myocardial Infarction: The EASY-MI Pilot Study.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Percentage of patients with at least 95% platelet aggregation inhibition, and mean platelet aggregation inhibition.
研究概览
简要总结
HYPOTHESES
- Bolus administration of total abciximab dose provides superior maximal and mean platelet aggregation inhibition (PAI) compared with standard bolus (0.25 mg/kg) administration.
- Total dose of abciximab can be given as a single bolus and is more effective than bolus (0.25 mg/kg) + 12 hrs infusion in terms of acute and mid-term angiographic and clinical results.
- Intracoronary (ic) abciximab administration is more effective than intravenous (iv) route of administration in terms of acute and mid-term angiographic and clinical results.
- There is a relationship between PAI and angiographic perfusion scores.
- Routine use of sirolimus-eluting stents (Cypher, Cordis) in primary-PCI is associated with a low rate of target vessel revascularization and complications.
- Cardiac MRI early and late after primary-PCI provides detailed information on myocardial injury and irreversible necrosis, which are correlated with angiographic perfusion scores.
- After uncomplicated trans-radial PCI, patients can be retransferred early to their referring center.
详细描述
OBJECTIVES AND END-POINTS The objectives of the present study are to assess the benefits and safety of 1) a single bolus of abciximab (100% dose) compared with the standard bolus (ca 80% of the total dose) + 12h infusion (ca 20% of the total dose), and 2) intracoronary abciximab bolus administration compared with intravenous route of abciximab administration in primary PCI.
The primary PLATELETS end-points are the percentage of patients with ≥ 95% platelet aggregation inhibition 10 minutes after abciximab bolus (MAX) and the mean platelet aggregation inhibition 10 minutes after abciximab bolus (MEAN).
The secondary CLINICAL end-points of the study are:
- The composite of death, stroke, repeat myocardial infarction, urgent target vessel revascularization and major bleedings at 30 days following primary PCI.
- The composite of cardiovascular death, repeat myocardial infarction and repeat target vessel revascularization at 6-months follow-up.
The secondary ANGIOGRAPHIC end-points of the study are:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patient with acute myocardial infarction eligible for primary PCI within 6 h of symptoms: patient must have prolonged, continuous (lasting at least 20 minutes) signs and symptoms of ischemia not eliminated with nitrates and onset within 6 h of randomization, and one of the following:
- •ST-segment elevation ≥ 2 mm in 2 or more contiguous precordial ECG leads (anterior infarction)
- •ST-segment depression ≥ 2 mm in V1, V2 or V2, V3 with reciprocal 1 mm ST-elevation in II, augmented unipolar foot (left leg) lead (AVF), and V6 (true posterior infarction)
- •ST-segment elevation ≥ 1 mm in 2 or more contiguous limb ECG leads (other infarction)
- •New or presumably new left bundle branch block (LBBB)
- •Patient must be > 18 years of age.
- •Patient and treating interventional cardiologist agree for randomization.
- •Patient will be informed of the randomization process and will sign an informed consent.
- •Diagnostic and therapeutic intervention performed through trans-radial/ulnar artery approach.
- •The culprit lesion can be identified on a native coronary vessel, which is suitable for primary PCI with stent implantation.
排除标准
- •Patient has received thrombolytic therapy (within the last 4 weeks) and is referred for rescue PCI
- •Concurrent participation in other investigational study
- •Femoral sheath (artery)
- •Intolerance or allergy to ASA, clopidogrel or ticlopidine precluding treatment for at least 12 months
- •Any significant blood dyscrasia, diathesis or INR > 2.0
- •Any clinical contraindication to abciximab (ReoPro®) administration i.e. known structural intracranial lesion, thrombocytopenia < 100,000, active or recent bleeding or hemoglobin level known < 10 g/dl.
- •Any glycoprotein IIb-IIIa inhibitors use in the previous 30 days
- •Uncontrolled high blood pressure i.e. systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 100 mmHg.
- •Life expectancy less than 6 months owing to non-cardiac cause
- •Infarction caused by in-stent thrombosis or restenosis
- •Cardiogenic shock evident before randomization
研究组 & 干预措施
Gr 1 - intracoronary + infusion
Experimental
abciximab bolus 0.25 mg/kg ic + 12 hrs iv infusion
干预措施: Abciximab (Drug)
Gr 2 - intracoronary
Experimental
100% abciximab bolus dose 0.3 mg/kg ic
干预措施: Abciximab (Drug)
Gr 3 - intravenous
Active Comparator
abciximab bolus dose 0.25 mg/kg iv + 12 hrs iv infusion
干预措施: Abciximab (Drug)
Gr 4 - intravenous
Experimental
100% abciximab bolus dose 0.3 mg/kg iv
干预措施: Abciximab (Drug)
结局指标
主要结局
Percentage of patients with at least 95% platelet aggregation inhibition, and mean platelet aggregation inhibition.
时间窗: 10 min after bolus of abciximab
次要结局
- Composite of death, stroke, repeat MI, urgent target vessel revascularization and major bleedings at 30 days following primary PCI.(30 days)
- Composite of cardiovascular death, repeat MI and repeat target vessel revascularization at 6-month follow-up.(6 months)
- Proportion of patients having myocardial blush grade 2-3 and TIMI 3 score at the end of PCI in the culprit vessel.(At end of PCI)
- Restenosis rate (diameter stenosis equal or higher than 50%) and late loss in the culprit vessel at 6-month follow-up.(6 months)
- Exploratory end-points: feasibility and safety of early transfer to the referring hospital after uncomplicated primary PCI, cardiac MRI measurements and platelet aggregation inhibition at 6hr post-PCI.(At 6hr post-PCI)
研究者
Olivier F. Bertrand
MD, PhD
Laval University
研究点 (1)
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