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

Phase 4

• Conditions: Myocardial Infarction
• Interventions: Other: abciximab and Sirolimus eluting stent; Other: tirofiban and bare metal stent; Other: abciximab followed by implantation of bare metal stent; Other: tirofiban and sirolimus-eluting stent

• Registration Number: NCT00229515
• Lead Sponsor: Marco Valgimigli

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-09-27
• Study First Submitted QC: 2005-09-27
• Study First Posted: 2005-09-29
• Primary Completion: 2007-04
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-26
• Last Update Posted: 2011-10-27
• Study Completion: 2012-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 744

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
2	abciximab and Sirolimus eluting stent	Abciximab followed by implantation of sirolimus-eluting stent in the culprit lesion
3	tirofiban and bare metal stent	tirofiban infusion followed by bare metal stent implantation
1	abciximab followed by implantation of bare metal stent	Patients will receive abciximab infusion at standard regimen prior undergoing percutaneous coronary intervention for STEMI followed by BMS implantation in the culprit lesion
4	tirofiban and sirolimus-eluting stent	tirofiban and sirolimus-eluting stent

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Cattedra di Cardiologia, Azienda Ospedaliera Universitaria di Ferrara; 🇮🇹 Ferrara, Italy