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

Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00229515
• Other study ID #: TSES-02-III
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 27, 2005
• Last updated: October 26, 2011
• Start date: November 2004
• Est. completion date: March 2012

Study information

• Verified date: October 2011
• Source: Università degli Studi di Ferrara
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 744
• Est. completion date: March 2012
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Other:
• abciximab followed by implantation of bare metal stent
Patients will receive infusion of abciximab at standard regimen before undergoing intervention for STEMI and then bare metal stent implantation in the culprit lesion
• abciximab and Sirolimus eluting stent
Patients will receive abciximab infusion at standard regimen followed by implantation of sirolimus-eluting stent in the culprit lesion
• tirofiban and bare metal stent
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
• tirofiban and sirolimus-eluting stent
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

Locations

Country	Name	City	State
Italy	Cattedra di Cardiologia, Azienda Ospedaliera Universitaria di Ferrara	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
Marco Valgimigli

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Valgimigli M, Percoco G, Malagutti P, Campo G, Ferrari F, Barbieri D, Cicchitelli G, McFadden EP, Merlini F, Ansani L, Guardigli G, Bettini A, Parrinello G, Boersma E, Ferrari R; STRATEGY Investigators. Tirofiban and sirolimus-eluting stent vs abciximab and bare-metal stent for acute myocardial infarction: a randomized trial. JAMA. 2005 May 4;293(17):2109-17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The evaluation of the degree of ST-segment resolution after the mechanical intervention.		90 minutes after last balloon inflation	No
Primary	The cumulative rate of death for any cause, reinfarction and target vessel revascularisation		8 months	Yes
Secondary	Death, recurrent acute myocardial infarction, target vessel revascularization and target lesion revascularisation, considered separately or in combination.		at any time during follow-up	Yes
Secondary	The evaluation of the cost-effectiveness of the involved experimental treatments.		8 months, 1,3 and 5 years	No
Secondary	stent thrombosis according to the ARC classification		any time during follow-up	Yes
Secondary	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	No
Secondary	bleeding rate defined according to different classifications including TIMI, Acuity, GUSTO and Steeple.		at 30 days, 1 year, 3 and 5 years	Yes