Multicentre 2x2 Factorial Randomised Study Comparing Tirofiban Administered With the Single High-Dose Bolus Versus Abciximab and Sirolimus Eluting Stent Versus Bare Metal Stent in Acute Myocardial Infarction - MULTI-STRATEGY Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 744
- 试验地点
- 2
- 主要终点
- The evaluation of the degree of ST-segment resolution after the mechanical intervention.
研究概览
简要总结
The purpose of this study is to determine which from the four combinations tirofiban+sirolimus eluting stent (SES), tirofiban+bare metal stent (BMS), abciximab+SES, abciximab+BMS is the possible gold standard treatment for ST-segment elevation myocardial infarction in terms of efficacy and cost-efficacy.
详细描述
The combination abciximab plus bare metal stent (BMS) is currently considered the standard therapy for AMI. The use of sirolimus eluting stent (SES) is related to a reduction of the need for urgent target vessel revascularization (TVR). With current acquisition prices for abciximab and SES, replacing abciximab with tirofiban, administered as a single high-dose bolus (SHDB) regimen, is a promising strategy that would preserve financial resources. In a recent study the combination tirofiban and SES resulted to be associated to an overall lower major adverse cardiovascular events (MACE) rate with respect to the abciximab plus BMS. However, since no conclusion can be drawn yet regarding the relative contribution of a specific GP IIb/IIIa inhibitor or a stent type with respect to the other, the combination of abciximab and SES may be associated to an even lower event rate with respect to SHDB tirofiban and SES, thus offsetting the higher initial cost.
Comparison(s): four strategies (SHDB tirofiban + BMS, SHDB tirofiban + SES, abciximab + BMS, abciximab + SES) are compared to determine the possible gold standard treatment for ST-segment elevation myocardial infarction in terms of efficacy and cost-efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •ST segment elevation myocardial infarction
- •Schedule for primary percutaneous coronary intervention
- •Informed consent
排除标准
- •Administration of fibrinolytic or any GP IIb/IIIa inhibitors for the treatment of current acute myocardial infarction or within 1 month before it
- •History of bleeding diathesis or allergy to the studies drug
- •Major surgery within 30 days
- •Limited life expectancy, e.g. neoplasms, others
- •Pregnancy
结局指标
主要结局
The evaluation of the degree of ST-segment resolution after the mechanical intervention.
时间窗: 90 minutes after last balloon inflation
The cumulative rate of death for any cause, reinfarction and target vessel revascularisation
时间窗: 8 months
次要结局
- Death, recurrent acute myocardial infarction, target vessel revascularization and target lesion revascularisation, considered separately or in combination.(at any time during follow-up)
- The evaluation of the cost-effectiveness of the involved experimental treatments.(8 months, 1,3 and 5 years)
- stent thrombosis according to the ARC classification(any time during follow-up)
- the degree of cumulative or single lead ST segment resolution at time frames different from the primary endpoint. the degree of residual ST segment elevation.(immediately after intervention, at 90 minutes and at discharge)
- bleeding rate defined according to different classifications including TIMI, Acuity, GUSTO and Steeple.(at 30 days, 1 year, 3 and 5 years)
研究者
Marco Valgimigli
Head of the Catheterization laboratory
Università degli Studi di Ferrara