Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-27 @ 6:39 PM
Study NCT ID:
NCT03385135
Status:
UNKNOWN
Last Update Posted:
2017-12-28
First Post:
2017-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Allopurinol and Endothelial Function in Diabetic CAD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000493', 'term': 'Allopurinol'}], 'ancestors': [{'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-26', 'studyFirstSubmitDate': '2017-12-14', 'studyFirstSubmitQcDate': '2017-12-26', 'lastUpdatePostDateStruct': {'date': '2017-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endothelium-dependent vasodilation', 'timeFrame': '2 months', 'description': 'Brachial Artery Flow-Mediated dilation (FMD)'}], 'secondaryOutcomes': [{'measure': 'Endothelium-independent vasodilation', 'timeFrame': '2 months', 'description': 'Changes in brachial artery diameter in response to nitrates'}, {'measure': 'Quality of Life (QoL)', 'timeFrame': '2 months', 'description': "Seattle Angina Questionnaire: a scale that quantifies patients' physical limitations caused by angina, the frequency of and recent changes in their symptoms, their satisfaction with treatment, and the degree to which they perceive their disease to affect their quality of life. Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life)."}, {'measure': 'Major adverse cardiac events (MACE)', 'timeFrame': '2 months', 'description': 'composite of cardiac death, non fatal myocardial infarction and unplanned coronary revascularization'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['allopurinol', 'coronary artery disease', 'diabetes', 'endothelial function'], 'conditions': ['Diabetes Mellitus', 'Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'This is a randomized trial assessing the impact of allopurinol on endothelial function in optimally treated diabetic patients with coronary artery disease. After initial screening, subjects were randomized to receive either optimal medical therapy (OMT) + allopurinol or OMT alone for 8 weeks. The dose of allopurinol was 300 mg for 4 weeks and 600 mg for 4 weeks with a 4-weekly check on hematology and biochemistry'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetes type 2\n* Known coronary artery disease with previous percutaneous coronary intervention and optimal medical therapy for at least one month\n\nExclusion Criteria:\n\n* Pregnant or breast- feeding women\n* creatinine clearance \\<60ml/min\n* Known history of gout disease or ongoing treatment with allopurinol\n* Allergy to allopurinol\n* Inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT03385135', 'acronym': 'ALLIENCE', 'briefTitle': 'Allopurinol and Endothelial Function in Diabetic CAD Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Tunis El Manar'}, 'officialTitle': 'Impact of ALLopurInol on Endothelial fuNCtion in diabEtic Patients Affected With Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'ALLIENCE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Allopurinol group', 'description': 'Optimal medical therapy associated with allopurinol. The dose of allopurinol is 300 mg for 4 weeks then 600 mg for 4 weeks', 'interventionNames': ['Drug: Allopurinol']}, {'type': 'NO_INTERVENTION', 'label': 'No Allopurinol group', 'description': 'Optimal medical therapy alone'}], 'interventions': [{'name': 'Allopurinol', 'type': 'DRUG', 'otherNames': ['Optimal Medical Therapy'], 'description': '300 mg for 4 weeks then 600 mg for 4 weeks in the active group', 'armGroupLabels': ['Allopurinol group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2008', 'city': 'Aryanah', 'status': 'RECRUITING', 'country': 'Tunisia', 'contacts': [{'name': 'Sami Kasbaoui, MD', 'role': 'CONTACT', 'email': 'kas.sami77@gmail.com', 'phone': '+21622560059'}, {'name': 'Marouane Boukhris, MD', 'role': 'CONTACT', 'email': 'mar1bou@hotmail.com', 'phone': '+21622557125'}], 'facility': 'Cardiology Department, Abderrahmen Mami Hospital', 'geoPoint': {'lat': 36.86012, 'lon': 10.19337}}], 'centralContacts': [{'name': 'Sami Kasbaoui, MD', 'role': 'CONTACT', 'email': 'kas.sami77@gmail.com', 'phone': '+21622560059'}, {'name': 'Marouane Boukhris, MD', 'role': 'CONTACT', 'email': 'mar1bou@hotmail.com', 'phone': '+21622557125'}], 'overallOfficials': [{'name': 'Salem Kachboura, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cardiology Department, Abderrahmen Mami Hospital, 2008, Ariana'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Tunis El Manar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kasbaoui sami', 'investigatorAffiliation': 'University Tunis El Manar'}}}}