Overview

This trial is active, not recruiting.

Condition myocardial infarction
Treatments abciximab followed by implantation of bare metal stent, abciximab and sirolimus eluting stent, tirofiban and bare metal stent, tirofiban and sirolimus-eluting stent
Phase phase 4
Sponsor Marco Valgimigli
Start date November 2004
End date April 2007
Trial size 744 participants
Trial identifier NCT00229515, TSES-02-III

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Patients will receive abciximab infusion at standard regimen prior undergoing percutaneous coronary intervention for STEMI followed by BMS implantation in the culprit lesion
abciximab followed by implantation of bare metal stent Glycoprotein IIB/IIIa inhibitors
Patients will receive infusion of abciximab at standard regimen before undergoing intervention for STEMI and then bare metal stent implantation in the culprit lesion
(Experimental)
Abciximab followed by implantation of sirolimus-eluting stent in the culprit lesion
abciximab and sirolimus eluting stent glycoprotein IIb/IIIa inhibitors
Patients will receive abciximab infusion at standard regimen followed by implantation of sirolimus-eluting stent in the culprit lesion
(Experimental)
tirofiban infusion followed by bare metal stent implantation
tirofiban and bare metal stent glycoprotein IIb/IIIa inhibitors
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
(Experimental)
tirofiban and sirolimus-eluting stent
tirofiban and sirolimus-eluting stent glycoprotein IIb/IIIa inhibitors
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

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2011.
Information provided to ClinicalTrials.gov by Università degli Studi di Ferrara.