Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2026-02-25 @ 11:07 PM
Study NCT ID:
NCT04497792
Status:
COMPLETED
Last Update Posted:
2021-09-22
First Post:
2020-07-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Empagliflozin for Patients With Diabetes Mellitus and Planned Percutaneous Coronary Interventions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C570240', 'term': 'empagliflozin'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, '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': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2019-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-15', 'studyFirstSubmitDate': '2020-07-30', 'studyFirstSubmitQcDate': '2020-08-03', 'lastUpdatePostDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'glomerular filtration rate(GFR)', 'timeFrame': 'baseline-24 weeks', 'description': 'The glomerular filtration rate(GFR) will be measured at each visit. GFR more than 60 will be recognized as normal.'}, {'measure': 'HbA1C level', 'timeFrame': 'baseline-24 weeks', 'description': 'The HbA1C will be measured (in %) at each visit. HbA1C less than 6.1% will be recognized as normal.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stable coronary artery disease', 'empagliflozin'], 'conditions': ['Coronary Artery Disease', 'Diabetes Mellitus', 'Percutaneous Coronary Intervention']}, 'descriptionModule': {'briefSummary': 'Aim: To study the effectiveness and safety of empagliflozin as a preoperative preparation tool, as well as to improve the long-term prognosis of planned percutaneous coronary interventions in patients with type 2 diabetes', 'detailedDescription': 'Patients with type 2 diabetes will be randomized into 2 groups using the envelope method. One group will receive empagliflozin 10 mg 1 month before planned percutaneous coronary interventions and for 12 months thereafter in addition to previously taken hypoglycemic therapy. Patients of the second group will continue to take previously prescribed hypoglycemic therapy.\n\nThus, the safety and effectiveness of empagliflozin for preoperative preparation of patients with type 2 diabetes before planned percutaneous coronary interventions will be evaluated, as well as the impact on the immediate and long-term outcomes of percutaneous coronary interventions in comparison with patients on standard hypoglycemic therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* signed inform concent\n* stable coronary artery disease\n* planned percutaneous coronary intervention\n* diabetes mellitus\n\nExclusion Criteria:\n\n* previously performed coronary revascularization\n* glomerular filtration rate less than 45 ml/min\n* intolerance to empagliflozin\n* serum potassium more than 5/5 mmol/l\n* heart failure (NYHA III-IV)\n* congenital heart disease\n* acute coronary syndrome less than 3 months before enrollment'}, 'identificationModule': {'nctId': 'NCT04497792', 'acronym': 'SAFARY', 'briefTitle': 'Safety and Efficacy of Empagliflozin for Patients With Diabetes Mellitus and Planned Percutaneous Coronary Interventions', 'organization': {'class': 'OTHER', 'fullName': 'Research Institute for Complex Problems of Cardiovascular Diseases, Russia'}, 'officialTitle': 'A Long-term, Randomized Study to Evaluate the Effects of Empagliflozin in Combination With Standard Hypoglycemic Therapy on Early and Long-term Results of Planned Percutaneous Coronary Interventions in Patients With Type 2 Diabetes.', 'orgStudyIdInfo': {'id': '16_001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'The treatment group are patients with stable coronary artery disease before planned percutaneous coronary intervention. All of them will receive empagliflozin additionally to previously taken hypoglycemic treatment.', 'interventionNames': ['Drug: Empagliflozin 10Mg Tab']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'patients continue previously prescribed medication intake', 'interventionNames': ['Drug: hypoglycemic therapy']}], 'interventions': [{'name': 'Empagliflozin 10Mg Tab', 'type': 'DRUG', 'otherNames': ['metformin'], 'description': 'Patients from treatment group received empagliflozin 10 mg daily additionally to previously prescribed diabetes medication', 'armGroupLabels': ['Treatment group']}, {'name': 'hypoglycemic therapy', 'type': 'DRUG', 'otherNames': ['metformin'], 'description': 'hypoglycemic therapy.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Olga Barbarash', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Institute for complex issues of cardiovascular diseases'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Research Institute for Complex Problems of Cardiovascular Diseases, Russia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal', 'investigatorFullName': 'Olga Barbarash', 'investigatorAffiliation': 'Research Institute for Complex Problems of Cardiovascular Diseases, Russia'}}}}