Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-03-02 @ 4:01 PM
Study NCT ID:
NCT03735134
Status:
UNKNOWN
Last Update Posted:
2018-11-08
First Post:
2018-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Colchicine in Periprocedural Myocardial Infarction: the Role of Alpha Defensin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-07', 'studyFirstSubmitDate': '2018-11-07', 'studyFirstSubmitQcDate': '2018-11-07', 'lastUpdatePostDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of PPMI post elective PCI', 'timeFrame': '24 hours post PCI', 'description': 'Occurrence of PPMI post elective PCI and its relation to defensin levels'}], 'secondaryOutcomes': [{'measure': 'Traditional inflammatory markers', 'timeFrame': '24 hours post PCI', 'description': 'Determination of traditional inflammatory markers including c-reactive protein, white blood cells and interleukin-6'}, {'measure': 'Major adverse cardiovascular events', 'timeFrame': '30 days', 'description': 'Determining the occurrence of major adverse cardiovascular events'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammation', 'Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'The aim of this research is to study the effect of a loading dose of colchicine on the occurrence of periprocedural myocardial infarction (PPMI) in elective percutaneous coronary intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients hospitalized with troponin negative events and scheduled for elective PCI\n\nExclusion Criteria:\n\n* Significant renal dysfunction\n* Significant liver dysfunction\n* Severe left ventricular dysfunction\n* Severe low weight\n* Chronic colchicine treatment'}, 'identificationModule': {'nctId': 'NCT03735134', 'briefTitle': 'Colchicine in Periprocedural Myocardial Infarction: the Role of Alpha Defensin', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'Colchicine in Periprocedural Myocardial Infarction: the Role of Alpha Defensin', 'orgStudyIdInfo': {'id': 'HYMC-99-18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Stable coronary artery disease patients who have been assigned to elective PCI and who will be given standard of care treatment', 'interventionNames': ['Drug: Standard of care treatment prior to elective PCI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Early colchicine loading dose', 'description': 'Stable coronary artery disease patients who have been assigned to elective PCI and who will be given standard of care treatment plus colchicine loading dose 12-24 hours before PCI', 'interventionNames': ['Drug: Colchicine Loading Dose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Late colchicine loading dose', 'description': 'Stable coronary artery disease patients who have been assigned to elective PCI and who will be given standard of care treatment plus colchicine loading dose one hour prior to PCI', 'interventionNames': ['Drug: Colchicine Loading Dose']}], 'interventions': [{'name': 'Colchicine Loading Dose', 'type': 'DRUG', 'description': 'Two milligrams of colchicine will be administrated in addition to the standard of care treatment', 'armGroupLabels': ['Early colchicine loading dose', 'Late colchicine loading dose']}, {'name': 'Standard of care treatment prior to elective PCI', 'type': 'DRUG', 'description': 'All medications normally given to patients prior to elective PCI', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'country': 'Israel', 'contacts': [{'name': 'Rami Abu Fanne, MD, PhD', 'role': 'CONTACT', 'email': 'ramia@hadassah.org.il', 'phone': '972-503573694'}], 'facility': 'Hille Yaffe Medical Center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'centralContacts': [{'name': 'Rami Abu Fanne, MD, PhD', 'role': 'CONTACT', 'email': 'ramia@hadassah.org.il', 'phone': '972-50-3573694'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}