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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Università degli Studi di Ferrara.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Marco Valgimigli, Università degli Studi di Ferrara
ClinicalTrials.gov Identifier:
NCT00229515
First received: September 27, 2005
Last updated: October 26, 2011
Last verified: October 2011

September 27, 2005
October 26, 2011
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.
Not Provided
Not Provided
 
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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Myocardial Infarction
  • 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
    Other Names:
    • Glycoprotein IIB/IIIa inhibitors
    • Stent
  • Other: abciximab and Sirolimus eluting stent
    Patients will receive abciximab infusion at standard regimen followed by implantation of sirolimus-eluting stent in the culprit lesion
    Other Names:
    • glycoprotein IIb/IIIa inhibitors
    • stent
    • DES
    • drug-eluting stent
  • Other: 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
    Other Names:
    • glycoprotein IIb/IIIa inhibitors
    • stent
    • uncoated stent
    • bare metal stent
  • Other: 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:
    • glycoprotein IIb/IIIa inhibitors
    • stent
    • drug-eluting stent
    • sirolimus-eluting stent
    • DES
    • SES
  • 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
    Intervention: Other: abciximab followed by implantation of bare metal stent
  • Experimental: 2
    Abciximab followed by implantation of sirolimus-eluting stent in the culprit lesion
    Intervention: Other: abciximab and Sirolimus eluting stent
  • Experimental: 3
    tirofiban infusion followed by bare metal stent implantation
    Intervention: Other: tirofiban and bare metal stent
  • Experimental: 4
    tirofiban and sirolimus-eluting stent
    Intervention: Other: tirofiban and sirolimus-eluting stent

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) 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
TSES-02-III
Yes
Marco Valgimigli, Università degli Studi di Ferrara
Marco Valgimigli
Not Provided
Study Chair: Roberto Ferrari, Professor Cattedra di Cardiologia, Azienda Ospedaliera Universitaria di Ferrara, Italy
Università degli Studi di Ferrara
October 2011

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