Multicentre 2x2 Factorial Randomised Study Comparing Tirofiban Versus Abciximab and SES Versus BMS in AMI
Information source: Universitaria di Ferrara
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Myocardial Infarction
Intervention: 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 (Other)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Universitaria di Ferrara Official(s) and/or principal investigator(s):
Roberto Ferrari, Professor, Study Chair, Affiliation: Cattedra di Cardiologia, Azienda Ospedaliera Universitaria di Ferrara, Italy
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.
Clinical Details
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
Study design: Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Primary outcome: The evaluation of the degree of ST-segment resolution after the mechanical intervention.The cumulative rate of death for any cause, reinfarction and target vessel revascularisation
Secondary outcome: Death, recurrent acute myocardial infarction, target vessel revascularization and target lesion revascularisation, considered separately or in combination.The evaluation of the cost-effectiveness of the involved experimental treatments. stent thrombosis according to the ARC classification 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. bleeding rate defined according to different classifications including TIMI, Acuity, GUSTO and Steeple.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Cattedra di Cardiologia, Azienda Ospedaliera Universitaria di Ferrara, Ferrara 44100, Italy
Additional Information
Related publications: 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.
Starting date: November 2004
Ending date: March 2012
Last updated: January 9, 2008
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