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The Effects of Facilitated Percutaeous Coronary Intervention in Acute Myocardial Infarction

This study has been completed.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00611169
First received: January 27, 2008
Last updated: February 7, 2008
Last verified: August 2007
History of Changes
  Purpose

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 Intervention Phase
Acute Myocardial Infarction
 Drug: tirofiban
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Infarct size and its transmural extent using MRI [ Time Frame: within the first 30 days after index procedure ] [ Designated as safety issue: No ]

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 [ Time Frame: at 6 month after index procedure ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: January 2006
Study Completion Date: August 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00611169

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

No publications provided

Responsible Party: HC Gwon, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00611169     History of Changes
Other Study ID Numbers: 2005-09-007-001
Study First Received: January 27, 2008
Last Updated: February 7, 2008
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
Angioplasty, Transluminal, Percutaneous Coronary
tirofiban
Magnetic Resonance Imaging
Myocardial Infarction

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
 Tirofiban
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013