Multicentre 2x2 Factorial Randomised Study Comparing Tirofiban Versus Abciximab and SES Versus BMS in AMI

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Other: abciximab followed by implantation of bare metal stent
* Other: abciximab and Sirolimus eluting stent
* Other: tirofiban and bare metal stent
* Other: tirofiban and sirolimus-eluting stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Patients will receive abciximab infusion at standard regimen prior undergoing percutaneous coronary intervention for STEMI followed by BMS implantation in the culprit lesion | Other: abciximab followed by implantation of bare metal stent<br>* Patients will receive infusion of abciximab at standard regimen before undergoing intervention for STEMI and then bare metal stent implantation in the culprit lesion<br>* Other names: Stent;|
| Experimental: 2<br>Abciximab followed by implantation of sirolimus-eluting stent in the culprit lesion | Other: abciximab and Sirolimus eluting stent<br>* Patients will receive abciximab infusion at standard regimen followed by implantation of sirolimus-eluting stent in the culprit lesion<br>* Other names: drug-eluting stent;|
| Experimental: 3<br>tirofiban infusion followed by bare metal stent implantation | Other: tirofiban and bare metal stent<br>* Patients will receive tirofiban infusion at high loading dose followed by standard infusion for 18-24 hours and subsequently they will be treated with bare metal stent implantation<br>* Other names: bare metal stent;|
| Experimental: 4<br>tirofiban and sirolimus-eluting stent | Other: tirofiban and sirolimus-eluting stent<br>* Patients will receive tirofiban infusion at high loading dose followed by standard infusion for 18-24 hours and subsequently they will be treated with sirolimus-eluting stent implantation<br>* Other names: SES;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The evaluation of the degree of ST-segment resolution after the mechanical intervention. |  | 90 minutes after last balloon inflation | 
| The cumulative rate of death for any cause, reinfarction and target vessel revascularisation |  | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial infarction, Revascularization, Stent, ST segment elevation