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GPIIbIIIa Inhibitors in the RESCUe and RESURCOR Networks at the Acute Myocardial Infarction

NCT ID: NCT00538317

Last Updated: 2008-11-24

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-11-30

Brief Summary

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In patients with acute myocardial infarction who are managed in the prehospital setting, and who will treated with primary angioplasty, we evaluate the benefit of an early administration of tirofiban, a powerful GPIIbIIIa inhibitors. Patients are randomised to early administration in the ambulance or administration in the cathlab. The primary endpoint is TIMI 2-3 flow in the first coronary opacification of the culprit artery.

Detailed Description

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Conditions

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Acute Myocardial Infarction

Keywords

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Acute myocardial infarction, GPIIbIIIa inhibitors, primary angioplasty, tirofiban

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

tirofiban bolus + perfusion started at the site of caring

Group Type EXPERIMENTAL

tirofiban

Intervention Type DRUG

bolus of 25 µg/kg lasting 3 minutes then 18h to 24h perfusion of 0.15 µg/kg/min

2

tirofiban bolus + perfusion started at the beginning of coronarography (usual use of tirofiban)

Group Type ACTIVE_COMPARATOR

tirofiban

Intervention Type DRUG

bolus of 25 µg/kg lasting 3 minutes then 18h to 24h perfusion of 0.15 µg/kg/min

Interventions

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tirofiban

bolus of 25 µg/kg lasting 3 minutes then 18h to 24h perfusion of 0.15 µg/kg/min

Intervention Type DRUG

tirofiban

bolus of 25 µg/kg lasting 3 minutes then 18h to 24h perfusion of 0.15 µg/kg/min

Intervention Type DRUG

Other Intervention Names

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agrastat agrastat

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years
* Information given to the patient and consent obtained
* Thoracic pain or symptoms of infarction
* Symptoms \< 12 hours
* ST deviation identified by electrocardiography (ECG) in at least 2 contiguous leads
* Transfer time to angioplasty room evaluated by the coordinating doctor as less than 90 minutes (from ECG diagnosis to arrival in angioplasty room)

Exclusion Criteria

* Physiological or pathological conditions not compatible with a revascularisation procedure (in the acute phase of myocardial infarction (MI)
* Administration of fibrinolytics or another antiGPIIBIIIa in the previous seven days
* Contraindications to aspirin or tirofiban or heparin
* Diagnosed severe kidney failure (dialysis, creatinin \> 350µmol/l
* Pregnancy
* Time for transfer to the angioplasty room evaluated by coordinating doctor as more than 90 minutes
* Subject participating in another trial
* Subject with high hemorrhagic risk.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Hospices Civils de Lyon

Principal Investigators

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Eric Bonnefoy-Cudraz, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Hospices Civils de Lyon

Lyon, , France

Site Status

Countries

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France

References

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El Khoury C, Dubien PY, Mercier C, Belle L, Debaty G, Capel O, Perret T, Savary D, Serre P, Bonnefoy E; AGIR-2 Investigators. Prehospital high-dose tirofiban in patients undergoing primary percutaneous intervention. The AGIR-2 study. Arch Cardiovasc Dis. 2010 May;103(5):285-92. doi: 10.1016/j.acvd.2010.04.005. Epub 2010 Jun 17.

Reference Type DERIVED
PMID: 20619238 (View on PubMed)

Other Identifiers

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2006-452

Identifier Type: -

Identifier Source: org_study_id