Multicentre 2x2 Factorial Randomised Study Comparing Tirofiban Versus Abciximab and SES Versus BMS in AMI - Full Text View

Sponsor:	Universitaria di Ferrara
Information provided by:	Universitaria di Ferrara
ClinicalTrials.gov Identifier:	NCT00229515

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
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:

MedlinePlus related topics: Heart Attack

Drug Information available for: Sirolimus Krestin Tirofiban hydrochloride Abciximab Tirofiban Tirofiban hydrochloride monohydrate

U.S. FDA Resources

Further study details as provided by Universitaria 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
1: 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	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
2: Experimental 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
3: Experimental 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
4: Experimental 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

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

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

Universitaria di Ferrara

Investigators

Study Chair:

Roberto Ferrari, Professor

Cattedra di Cardiologia, Azienda Ospedaliera Universitaria di Ferrara, Italy

More Information

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.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Valgimigli M, Campo G, Percoco G, Bolognese L, Vassanelli C, Colangelo S, de Cesare N, Rodriguez AE, Ferrario M, Moreno R, Piva T, Sheiban I, Pasquetto G, Prati F, Nazzaro MS, Parrinello G, Ferrari R; Multicentre Evaluation of Single High-Dose Bolus Tirofiban vs Abciximab With Sirolimus-Eluting Stent or Bare Metal Stent in Acute Myocardial Infarction Study (MULTISTRATEGY) Investigators. Comparison of angioplasty with infusion of tirofiban or abciximab and with implantation of sirolimus-eluting or uncoated stents for acute myocardial infarction: the MULTISTRATEGY randomized trial. JAMA. 2008 Apr 16;299(15):1788-99. Epub 2008 Mar 30.

Responsible Party:	Azienda Ospedaliera Universitaria di Ferrara ( Marco Valgimigli )
Study ID Numbers:	TSES-02-III
Study First Received:	September 27, 2005
Last Updated:	January 9, 2008
ClinicalTrials.gov Identifier:	NCT00229515 History of Changes
Health Authority:	Italy: Ethics Committee

Keywords provided by Universitaria di Ferrara:

Myocardial infarction
Revascularization
Stent
ST segment elevation

Additional relevant MeSH terms:

Sirolimus
Anti-Infective Agents
Interferon Inducers
Radiation-Protective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Tirofiban
Myocardial Ischemia
Hematologic Agents
Physiological Effects of Drugs
Fibrinolytic Agents
Antibiotics, Antineoplastic
Anti-Bacterial Agents
Fibrin Modulating Agents

Necrosis
Pathologic Processes
Antifungal Agents
Therapeutic Uses
Cardiovascular Diseases
Myocardial Infarction
Anticoagulants
Heart Diseases
Vascular Diseases
Adjuvants, Immunologic
Abciximab
Cardiovascular Agents
Ischemia
Immunosuppressive Agents
Antiviral Agents

ClinicalTrials.gov processed this record on November 05, 2009