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Multicentre 2x2 Factorial Randomised Study Comparing Tirofiban Versus Abciximab and SES Versus BMS in AMI
This study is ongoing, but not recruiting participants.
Study NCT00229515   Information provided by Universitaria di Ferrara
First Received: September 27, 2005   Last Updated: January 9, 2008   History of Changes

September 27, 2005
January 9, 2008
November 2004
April 2007   (final data collection date for primary outcome measure)
  • The evaluation of the degree of ST-segment resolution after the mechanical intervention. [ Time Frame: 90 minutes after last balloon inflation ] [ Designated as safety issue: No ]
  • The cumulative rate of death for any cause, reinfarction and target vessel revascularisation [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
  • The evaluation of the degree of ST-segment resolution obtained immediately after the mechanical intervention at randomisation.
  • The incidence of the composite of death, nonfatal AMI, stroke and clinically-driven target vessel revascularization at 8 months.
Complete list of historical versions of study NCT00229515 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • The evaluation of the cost-effectiveness of the involved experimental treatments. [ Time Frame: 8 months, 1,3 and 5 years ] [ Designated as safety issue: No ]
  • stent thrombosis according to the ARC classification [ Time Frame: any time during follow-up ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • bleeding rate defined according to different classifications including TIMI, Acuity, GUSTO and Steeple. [ Time Frame: at 30 days, 1 year, 3 and 5 years ] [ Designated as safety issue: Yes ]
  • Death, recurrent acute myocardial infarction, target vessel revascularization and target lesion revascularisation, considered separately or in combination, at 30 days, 4 months, 8 months, 1 and 3 years.
  • The evaluation of the cost-effectiveness of the involved treatments at 30 days, 4 months, 8 months, 1 and 3 years.
 
Multicentre 2x2 Factorial Randomised Study Comparing Tirofiban Versus Abciximab and SES Versus BMS in AMI
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.

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.

Phase IV
Interventional
Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Myocardial Infarction
  • Other: 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
  • 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
  • Experimental: Abciximab followed by implantation of sirolimus-eluting stent in the culprit lesion
  • Experimental: tirofiban infusion followed by bare metal stent implantation
  • Experimental: tirofiban and sirolimus-eluting stent

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
744
March 2012
April 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00229515
Marco Valgimigli, Azienda Ospedaliera Universitaria di Ferrara
TSES-02-III
Universitaria di Ferrara
 
Study Chair: Roberto Ferrari, Professor Cattedra di Cardiologia, Azienda Ospedaliera Universitaria di Ferrara, Italy
Universitaria di Ferrara
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP