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
  Purpose

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.


Condition Intervention Phase
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
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Università degli Studi di Ferrara:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 744
Study Start Date: November 2004
Estimated Study Completion Date: March 2012
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Experimental: 2
Abciximab followed by implantation of sirolimus-eluting stent in the culprit lesion
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
Experimental: 3
tirofiban infusion followed by bare metal stent implantation
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
Experimental: 4
tirofiban and sirolimus-eluting 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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00229515

Locations
Italy
Cattedra di Cardiologia, Azienda Ospedaliera Universitaria di Ferrara
Ferrara, Italy, 44100
Sponsors and Collaborators
Marco Valgimigli
Investigators
Study Chair: Roberto Ferrari, Professor Cattedra di Cardiologia, Azienda Ospedaliera Universitaria di Ferrara, Italy
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marco Valgimigli, Head of the Catheterization laboratory, Università degli Studi di Ferrara
ClinicalTrials.gov Identifier: NCT00229515     History of Changes
Other Study ID Numbers: TSES-02-III
Study First Received: September 27, 2005
Last Updated: October 26, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by Università degli Studi di Ferrara:
Myocardial infarction
Revascularization
Stent
ST segment elevation

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Krestin
Sirolimus
Everolimus
Tirofiban
Abciximab
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Interferon Inducers
Radiation-Protective Agents
Protective Agents
Anti-Bacterial Agents
Antifungal Agents
Immunosuppressive Agents
Fibrinolytic Agents

ClinicalTrials.gov processed this record on August 19, 2014