We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT00611169
Recruitment Status : Completed
First Posted : February 8, 2008
Last Update Posted : February 8, 2008
Sponsor:
Information provided by:

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  (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
Primary Completion Date : February 2007
Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

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


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT00611169


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

Responsible Party: HC Gwon, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00611169     History of Changes
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
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
Platelet Aggregation Inhibitors