The Effects of Facilitated Percutaeous Coronary Intervention in Acute Myocardial Infarction

NCT ID: NCT00611169

Last Updated: 2008-02-08

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-08-31

Brief Summary

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The purpose of this study to investigate whether the administration of high-dose tirofiban before primary PCI could reduce myocardial infarct size, using analysis of contrast-enhanced magnetic resonance imaging.

Detailed Description

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Conditions

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Acute Myocardial Infarction

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

Aspirin, clopidogrel, unfractionated heparin plus tirofiban infusion at high bolus dose

Group Type EXPERIMENTAL

tirofiban

Intervention Type DRUG

tirofiban (25 μg/kg bolus and 0.15 μg/kg/min maintenance infusion for 24 hours)

2

Aspirin, clopidogrel, unfractionated heparin

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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tirofiban

tirofiban (25 μg/kg bolus and 0.15 μg/kg/min maintenance infusion for 24 hours)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* presence of chest pain for more than 30 minutes but less than 12 hours after symptom onset
* ST-segment elevation more than 1 mm in two or more contiguous leads or presumably a new-onset left bundle branch blockage

Exclusion Criteria

* hemodynamic instability
* history of MI
* old age \> 80years
* Patients with bleeding diathesis (coagulopathy, thrombocytopenia or platelet dysfunction, Gastrointestinal or genitourinary bleeding within the prior 3 months)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Samsung Medical Center

Principal Investigators

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Hyeon-Cheol Gwon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Other Identifiers

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2005-09-007-001

Identifier Type: -

Identifier Source: org_study_id

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