The Effects of Facilitated Percutaeous Coronary Intervention in Acute Myocardial Infarction

Sponsor

Samsung Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00611169

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myocardial Infarction	Drug: tirofiban	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Effects of Facilitated Percutaeous Coronary Intervention Compared to Primary Percutaneous Coronary Intervention in Patients With ST-Segment Elevation Acute Myocardial Infarction

Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Feb 1, 2007

Actual Study Completion Date :

Aug 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Aspirin, clopidogrel, unfractionated heparin plus tirofiban infusion at high bolus dose	Drug: tirofiban tirofiban (25 μg/kg bolus and 0.15 μg/kg/min maintenance infusion for 24 hours)
No Intervention: 2 Aspirin, clopidogrel, unfractionated heparin

Arm

Intervention/Treatment

Experimental: 1

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

Drug: tirofiban

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

No Intervention: 2

Aspirin, clopidogrel, unfractionated heparin

Outcome Measures

Primary Outcome Measures

Infarct size and its transmural extent using MRI [within the first 30 days after index procedure]

Secondary Outcome Measures

pre-PCI thrombolysis in myocardial infarction grade, post-PCI myocardial blush grade, ST-segment resolution on electrocardiography, and left ventricular ejection fraction on echocardiography [at 6 month after index procedure]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)