Multicentre 2x2 Factorial Randomised Study Comparing Tirofiban Versus Abciximab and SES Versus BMS in AMI
This trial is active, not recruiting.
|Treatments||abciximab followed by implantation of bare metal stent, abciximab and sirolimus eluting stent, tirofiban and bare metal stent, tirofiban and sirolimus-eluting stent|
|Start date||November 2004|
|End date||April 2007|
|Trial size||744 participants|
|Trial identifier||NCT00229515, TSES-02-III|
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.
|Endpoint classification||efficacy study|
|Intervention model||factorial assignment|
The evaluation of the degree of ST-segment resolution after the mechanical intervention.
time frame: 90 minutes after last balloon inflation
The cumulative rate of death for any cause, reinfarction and target vessel revascularisation
time frame: 8 months
Death, recurrent acute myocardial infarction, target vessel revascularization and target lesion revascularisation, considered separately or in combination.
time frame: at any time during follow-up
The evaluation of the cost-effectiveness of the involved experimental treatments.
time frame: 8 months, 1,3 and 5 years
stent thrombosis according to the ARC classification
time frame: 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.
time frame: immediately after intervention, at 90 minutes and at discharge
bleeding rate defined according to different classifications including TIMI, Acuity, GUSTO and Steeple.
time frame: at 30 days, 1 year, 3 and 5 years
Male or female participants at least 18 years old.
Inclusion Criteria: - ST segment elevation myocardial infarction - Schedule for primary percutaneous coronary intervention - Informed consent Exclusion Criteria: - 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
|Official title||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|
|Description||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.|
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