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

NCT00229515 | Unknown Phase 4 DMC

• 1 other identifier: TSES-02-III
• Study Type: interventional
• Target: 744
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myocardial Infarction

Keywords

Myocardial infarction; Revascularization; Stent; ST segment elevation

Outcome Measures

Primary Outcomes (2)

• The evaluation of the degree of ST-segment resolution after the mechanical intervention.

  90 minutes after last balloon inflation

• The cumulative rate of death for any cause, reinfarction and target vessel revascularisation

  8 months

Secondary Outcomes (5)

• Death, recurrent acute myocardial infarction, target vessel revascularization and target lesion revascularisation, considered separately or in combination.

  at any time during follow-up

• The evaluation of the cost-effectiveness of the involved experimental treatments.

  8 months, 1,3 and 5 years

• stent thrombosis according to the ARC classification

  any time during follow-up

• 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.

  immediately after intervention, at 90 minutes and at discharge

• bleeding rate defined according to different classifications including TIMI, Acuity, GUSTO and Steeple.

  at 30 days, 1 year, 3 and 5 years

Study Arms (4)

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

2

EXPERIMENTAL

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

Other: abciximab and Sirolimus eluting stent

3

EXPERIMENTAL

tirofiban infusion followed by bare metal stent implantation

Other: tirofiban and bare metal stent

4

EXPERIMENTAL

tirofiban and sirolimus-eluting stent

Other: tirofiban and sirolimus-eluting stent

Interventions

abciximab followed by implantation of bare metal stent 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

Also known as: Glycoprotein IIB/IIIa inhibitors, Stent

1

abciximab and Sirolimus eluting stent OTHER

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

Also known as: glycoprotein IIb/IIIa inhibitors, stent, DES, drug-eluting stent

2

tirofiban and bare metal stent 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

Also known as: glycoprotein IIb/IIIa inhibitors, stent, uncoated stent, bare metal stent

3

tirofiban and sirolimus-eluting stent 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

Also known as: glycoprotein IIb/IIIa inhibitors, stent, drug-eluting stent, sirolimus-eluting stent, DES, SES

4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ST segment elevation myocardial infarction
• Schedule for primary percutaneous coronary intervention
• Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Marco Valgimigli: lead

Study Sites (1)

Cattedra di Cardiologia, Azienda Ospedaliera Universitaria di Ferrara

Ferrara, 44100, Italy

Location

Related Publications (3)

• 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.

  PMID: 15870414 BACKGROUND

• 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.

  PMID: 21251631 DERIVED

• 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.

  PMID: 18375998 DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Stents; Abciximab; Drug-Eluting Stents; Tirofiban

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Tyrosine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids

Study Officials

• Roberto Ferrari, Professor

  Cattedra di Cardiologia, Azienda Ospedaliera Universitaria di Ferrara, Italy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of the Catheterization laboratory

Study Record Dates

• First Submitted: September 27, 2005
• First Posted: September 29, 2005
• Study Start: November 1, 2004
• Primary Completion: April 1, 2007
• Study Completion: March 1, 2012
• Last Updated: October 27, 2011

Record last verified: 2011-10

Locations

IT (1)