Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT05745818
Status:
UNKNOWN
Last Update Posted:
2023-02-27
First Post:
2023-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Colchicine for Reduction of Periprocedural Myocardial Injury in Percutaneous Coronary Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003078', 'term': 'Colchicine'}], 'ancestors': [{'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-16', 'studyFirstSubmitDate': '2023-02-16', 'studyFirstSubmitQcDate': '2023-02-16', 'lastUpdatePostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MACEs', 'timeFrame': 'one month', 'description': 'Major Adverse Cardiac Events'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colchicine - PCI - PPMI'], 'conditions': ['Periprocedural Myocardial Infarction', 'Periprocedural Myocardial Injury']}, 'descriptionModule': {'briefSummary': 'Study of role of colchicine in reducing periprocedural myocardial injury in patients prepared for elective PCI and its role in reduction of MACEs.', 'detailedDescription': 'Prospective open-label randomized cohort study including two groups of patients admitted and prepared for elective PCI at cardiology unit, IMD, Sohag University Hospital, these two groups are:\n\n1. group of patients received oral tablet colchicine 6-24 hours before PCI loading dose 1 mg followed by 500 mcg after one hour.\n\n N.B. usual side effects of colchicine gastrointestinal disorders rarely, myalgia and weakness. Treatment of side effects symptomatic treatment ( antiemetic, etc.)\n2. control group of patients. Number of patients according to sample size equation.\n\nSample size equation is used to calculate the minimum size of the required sample:\n\nn = (z)2 p (1- p) / d2\n\n* Number of patients according to sample size equation about 300 patients 150 patient in each group of study.\n* Estimated study duration 2 years.\n* N.B. Randomization method: first patient prepared to PCI will be included in colchicine group second patient will be included in control group and so on.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'IHD patients in IMD sohag university hospital prepared for elective PCI', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Elective PCI in ACS patients with cardiac troponin peaked and stabilized and CCS patients .\n2. PP Myocardial Injury (Any increase in post-PCI troponin if pre-PCI troponin is negative or rise in post-PCI troponin above baseline pre-PCI troponin when it is peaked and stabilized).\n3. PPMI (rise in post-PCI troponin plus new evidence of ischemia).\n\nExclusion Criteria:\n\n1. Patients with active infections.\n2. Patients taking anti-inflammatory medications.\n3. Patients presented with ACS( still rising troponin).\n4. Severe renal impairment ( creatinine clearance \\< 45 ml/min ).\n5. Primary PCI, rescue PCI, pharmacoinvasive therapy.\n6. Connective tissue diseases.'}, 'identificationModule': {'nctId': 'NCT05745818', 'briefTitle': 'Colchicine for Reduction of Periprocedural Myocardial Injury in Percutaneous Coronary Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Colchicine for Reduction of Periprocedural Myocardial Injury in Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': 'Colchicine study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'colchicine group', 'interventionNames': ['Drug: Colchicine Pill']}, {'label': 'control group'}], 'interventions': [{'name': 'Colchicine Pill', 'type': 'DRUG', 'description': 'oral pills', 'armGroupLabels': ['colchicine group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Tarik Mahmoud Abdellah', 'investigatorAffiliation': 'Sohag University'}}}}