Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-02-22 @ 7:01 PM
Study NCT ID:
NCT00611169
Status:
COMPLETED
Last Update Posted:
2008-02-08
First Post:
2008-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Facilitated Percutaeous Coronary Intervention in Acute Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077466', 'term': 'Tirofiban'}], 'ancestors': [{'id': 'D014443', 'term': 'Tyrosine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-08', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-02-07', 'studyFirstSubmitDate': '2008-01-27', 'studyFirstSubmitQcDate': '2008-02-07', 'lastUpdatePostDateStruct': {'date': '2008-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infarct size and its transmural extent using MRI', 'timeFrame': 'within the first 30 days after index procedure'}], 'secondaryOutcomes': [{'measure': 'pre-PCI thrombolysis in myocardial infarction grade, post-PCI myocardial blush grade, ST-segment resolution on electrocardiography, and left ventricular ejection fraction on echocardiography', 'timeFrame': 'at 6 month after index procedure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Angioplasty, Transluminal, Percutaneous Coronary', 'tirofiban', 'Magnetic Resonance Imaging', 'Myocardial Infarction'], 'conditions': ['Acute Myocardial Infarction']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* presence of chest pain for more than 30 minutes but less than 12 hours after symptom onset\n* ST-segment elevation more than 1 mm in two or more contiguous leads or presumably a new-onset left bundle branch blockage\n\nExclusion Criteria:\n\n* hemodynamic instability\n* history of MI\n* old age \\> 80years\n* Patients with bleeding diathesis (coagulopathy, thrombocytopenia or platelet dysfunction, Gastrointestinal or genitourinary bleeding within the prior 3 months)'}, 'identificationModule': {'nctId': 'NCT00611169', 'briefTitle': 'The Effects of Facilitated Percutaeous Coronary Intervention in Acute Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'The Effects of Facilitated Percutaeous Coronary Intervention Compared to Primary Percutaneous Coronary Intervention in Patients With ST-Segment Elevation Acute Myocardial Infarction', 'orgStudyIdInfo': {'id': '2005-09-007-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Aspirin, clopidogrel, unfractionated heparin plus tirofiban infusion at high bolus dose', 'interventionNames': ['Drug: tirofiban']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'Aspirin, clopidogrel, unfractionated heparin'}], 'interventions': [{'name': 'tirofiban', 'type': 'DRUG', 'description': 'tirofiban (25 μg/kg bolus and 0.15 μg/kg/min maintenance infusion for 24 hours)', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Hyeon-Cheol Gwon, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'HC Gwon', 'oldOrganization': 'Samsung Medical Center'}}}}