Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2026-02-25 @ 4:14 AM
Study NCT ID:
NCT05911659
Status:
UNKNOWN
Last Update Posted:
2023-06-22
First Post:
2023-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Individualized and Combined Effects of Diabetes and Smoking on the Antiplatelet Activity of Ticagrelor in Acute Myocardial Infarction Patients Undergoing Primary PCI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077486', 'term': 'Ticagrelor'}], 'ancestors': [{'id': 'D000241', 'term': 'Adenosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-10', 'studyFirstSubmitDate': '2023-06-10', 'studyFirstSubmitQcDate': '2023-06-10', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Platelet Reactivity Index and maximum platelet aggregation', 'timeFrame': '24 hours after PCI', 'description': 'Platelet aggregation indicator'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Individualized and Combined Effects of Smoking and Diabetes on the Antiplatelet Activity in Patients Undergoing Primary Percutaneous Coronary Intervention']}, 'descriptionModule': {'briefSummary': 'Background:Diabetes and smoking are common factors found to increase platelet reactivity in patients undergoing primary PCI. Objective: Compare the individualized and combined effects of smoking and diabetes on the antiplatelet activity in patients undergoing primary PCI. Methods: sixty patients were recruited in this study. Patients were allocated to one of four groups according to the diabetes and smoking status. Non smokers- non diabetic patients, smokers non diabetic patients, non smokers diabetic patients, and smokers diabetic patients, 15 patients in each group. All patients received 180 mg ticagrelor before PCI. Platelet reactivity index(PRI) and maximum platelet aggregation were measured 24 hours after ticagrelor loading dose for each patient as indicators for antiplatelet efficacy. PRI and/or MPA values \\> 50% were defined as high platelet reactivity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with ACS undergoing PCI', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAcute coronary syndrome (ACS) undergoing PCI\n\nExclusion Criteria:\n\nPatients who had a history of severe bleeding, serious bleeding tendency, history of intracranial hemorrhage, signs of active bleeding, thrombocytopenia, uncontrolled hypertension, hypersensitivity to the used drugs (clopidogrel or ticagrelor), concomitant use of strong CYP inducers or inhibitors, and/or severe liver disorders were excluded from the study.\n\nPatients with previous history of coronary artery disease, previous PCI or patients administering other antiplatelets were excluded from the current study.'}, 'identificationModule': {'nctId': 'NCT05911659', 'briefTitle': 'Individualized and Combined Effects of Diabetes and Smoking on the Antiplatelet Activity of Ticagrelor in Acute Myocardial Infarction Patients Undergoing Primary PCI', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Ndividualized and Combined Effects of Diabetes and Smoking on the Antiplatelet Activity of Ticagrelor in Acute Myocardial Infarction Patients Undergoing Primary PCI', 'orgStudyIdInfo': {'id': 'Al-Azhar University'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non smokers- non diabetic patients', 'interventionNames': ['Drug: Ticagrelor']}, {'label': 'smokers non diabetic patients', 'interventionNames': ['Drug: Ticagrelor']}, {'label': 'non smokers diabetic patients', 'interventionNames': ['Drug: Ticagrelor']}, {'label': 'smokers diabetic patients', 'interventionNames': ['Drug: Ticagrelor']}], 'interventions': [{'name': 'Ticagrelor', 'type': 'DRUG', 'otherNames': ['Primary percutaneous coronary intervention (PCI)'], 'description': 'Patients with acute coronary syndromes undergo primary PCI and administered 180 mg loading dose ticagrelor before PCI', 'armGroupLabels': ['Non smokers- non diabetic patients', 'non smokers diabetic patients', 'smokers diabetic patients', 'smokers non diabetic patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Nasima M Elkenany, Ph.D.', 'role': 'CONTACT'}], 'facility': 'Faculty of medicine of girls, Cardiology department, Al-Azhar University in Cairo', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Nasima M El-Kenany, Ph.D', 'role': 'CONTACT', 'email': 'mina.moharebmedicinewolters@gmail.com', 'phone': '01007844927', 'phoneExt': '+20'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mina Wageh Mohareb', 'class': 'OTHER'}, 'collaborators': [{'name': 'Al-Azhar University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mina Wageh Mohareb', 'investigatorAffiliation': 'Cairo University'}}}}