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The Effects of Facilitated Percutaeous Coronary Intervention in Acute Myocardial Infarction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00611169
Recruitment Status : Completed
First Posted : February 8, 2008
Last Update Posted : February 8, 2008
Information provided by:
Samsung Medical Center

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

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Study Type : Interventional  (Clinical Trial)
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 : January 2006
Actual Primary Completion Date : February 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Tirofiban

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

Primary Outcome Measures :
  1. Infarct size and its transmural extent using MRI [ Time Frame: within the first 30 days after index procedure ]

Secondary Outcome Measures :
  1. pre-PCI thrombolysis in myocardial infarction grade, post-PCI myocardial blush grade, ST-segment resolution on electrocardiography, and left ventricular ejection fraction on echocardiography [ Time Frame: at 6 month after index procedure ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00611169

Sponsors and Collaborators
Samsung Medical Center
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Principal Investigator: Hyeon-Cheol Gwon, MD, PhD Samsung Medical Center

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Responsible Party: HC Gwon, Samsung Medical Center Identifier: NCT00611169    
Other Study ID Numbers: 2005-09-007-001
First Posted: February 8, 2008    Key Record Dates
Last Update Posted: February 8, 2008
Last Verified: August 2007
Keywords provided by Samsung Medical Center:
Angioplasty, Transluminal, Percutaneous Coronary
Magnetic Resonance Imaging
Myocardial Infarction
Additional relevant MeSH terms:
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Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors