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

October 26, 2011 updated by: Marco Valgimigli

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

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

744

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ferrara, Italy, 44100
        • Cattedra di Cardiologia, Azienda Ospedaliera Universitaria di Ferrara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Patients will receive abciximab infusion at standard regimen prior undergoing percutaneous coronary intervention for STEMI followed by BMS implantation in the culprit lesion
Patients will receive infusion of abciximab at standard regimen before undergoing intervention for STEMI and then bare metal stent implantation in the culprit lesion
Other Names:
  • Stent
  • Glycoprotein IIB/IIIa inhibitors
Experimental: 2
Abciximab followed by implantation of sirolimus-eluting stent in the culprit lesion
Patients will receive abciximab infusion at standard regimen followed by implantation of sirolimus-eluting stent in the culprit lesion
Other Names:
  • DES
  • stent
  • drug-eluting stent
  • glycoprotein IIb/IIIa inhibitors
Experimental: 3
tirofiban infusion followed by bare metal stent implantation
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
Other Names:
  • stent
  • glycoprotein IIb/IIIa inhibitors
  • uncoated stent
  • bare metal stent
Experimental: 4
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
Other Names:
  • DES
  • stent
  • SES
  • drug-eluting stent
  • sirolimus-eluting stent
  • glycoprotein IIb/IIIa inhibitors

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
8 months, 1,3 and 5 years
stent thrombosis according to the ARC classification
Time Frame: any time during follow-up
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
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
at 30 days, 1 year, 3 and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Roberto Ferrari, Professor, Cattedra di Cardiologia, Azienda Ospedaliera Universitaria di Ferrara, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

April 1, 2007

Study Completion (Anticipated)

March 1, 2012

Study Registration Dates

First Submitted

September 27, 2005

First Submitted That Met QC Criteria

September 27, 2005

First Posted (Estimate)

September 29, 2005

Study Record Updates

Last Update Posted (Estimate)

October 27, 2011

Last Update Submitted That Met QC Criteria

October 26, 2011

Last Verified

October 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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