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

NCT ID: NCT00229515

Last Updated: 2011-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

744 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Patients will receive abciximab infusion at standard regimen prior undergoing percutaneous coronary intervention for STEMI followed by BMS implantation in the culprit lesion

Group Type ACTIVE_COMPARATOR

abciximab followed by implantation of bare metal stent

Intervention Type OTHER

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

Abciximab followed by implantation of sirolimus-eluting stent in the culprit lesion

Group Type EXPERIMENTAL

abciximab and Sirolimus eluting stent

Intervention Type OTHER

Patients will receive abciximab infusion at standard regimen followed by implantation of sirolimus-eluting stent in the culprit lesion

3

tirofiban infusion followed by bare metal stent implantation

Group Type EXPERIMENTAL

tirofiban and bare metal stent

Intervention Type OTHER

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

tirofiban and sirolimus-eluting stent

Group Type EXPERIMENTAL

tirofiban and sirolimus-eluting stent

Intervention Type OTHER

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

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

Other Intervention Names

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Glycoprotein IIB/IIIa inhibitors Stent glycoprotein IIb/IIIa inhibitors stent DES drug-eluting stent glycoprotein IIb/IIIa inhibitors stent uncoated stent bare metal stent glycoprotein IIb/IIIa inhibitors stent drug-eluting stent sirolimus-eluting stent DES SES

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marco Valgimigli

OTHER

Sponsor Role lead

Responsible Party

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Marco Valgimigli

Head of the Catheterization laboratory

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Roberto Ferrari, Professor

Role: STUDY_CHAIR

Cattedra di Cardiologia, Azienda Ospedaliera Universitaria di Ferrara, Italy

Locations

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Cattedra di Cardiologia, Azienda Ospedaliera Universitaria di Ferrara

Ferrara, , Italy

Site Status

Countries

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Italy

References

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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. doi: 10.1001/jama.293.17.2109.

Reference Type BACKGROUND
PMID: 15870414 (View on PubMed)

Garg S, Sarno G, Serruys PW, Rodriguez AE, Bolognese L, Anselmi M, De Cesare N, Colangelo S, Moreno R, Gambetti S, Monti M, Bristot L, Bressers M, Garcia-Garcia HM, Parrinello G, Campo G, Valgimigli M; STRATEGY and MULTISTRATEGY Investigators. Prediction of 1-year clinical outcomes using the SYNTAX score in patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: a substudy of the STRATEGY (Single High-Dose Bolus Tirofiban and Sirolimus-Eluting Stent Versus Abciximab and Bare-Metal Stent in Acute Myocardial Infarction) and MULTISTRATEGY (Multicenter Evaluation of Single High-Dose Bolus Tirofiban Versus Abciximab With Sirolimus-Eluting Stent or Bare-Metal Stent in Acute Myocardial Infarction Study) trials. JACC Cardiovasc Interv. 2011 Jan;4(1):66-75. doi: 10.1016/j.jcin.2010.09.017.

Reference Type DERIVED
PMID: 21251631 (View on PubMed)

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. doi: 10.1001/jama.299.15.joc80026. Epub 2008 Mar 30.

Reference Type DERIVED
PMID: 18375998 (View on PubMed)

Other Identifiers

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TSES-02-III

Identifier Type: -

Identifier Source: org_study_id