Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2026-01-04 @ 4:14 PM
Study NCT ID:
NCT05333159
Status:
UNKNOWN
Last Update Posted:
2022-04-18
First Post:
2022-04-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of SGLT-2 Inhibitor in Patients With CAD and DM Undergoing PCI.
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'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077203', 'term': 'Sodium-Glucose Transporter 2 Inhibitors'}, {'id': 'C529054', 'term': 'dapagliflozin'}, {'id': 'D000068896', 'term': 'Canagliflozin'}, {'id': 'C570240', 'term': 'empagliflozin'}], 'ancestors': [{'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D007004', 'term': 'Hypoglycemic Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1424}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-12', 'studyFirstSubmitDate': '2022-04-12', 'studyFirstSubmitQcDate': '2022-04-12', 'lastUpdatePostDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major adverse cardiovascular and cerebrovascular events (MACCEs)', 'timeFrame': '12 months', 'description': 'MACCE, defined as a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal myocardial stroke and unplanned coronary revascularization. Event rates are adjudicated by an endpoint committee based on the time to the first occurrence of MACCEs.'}], 'secondaryOutcomes': [{'measure': 'Changes of insulin resistance index', 'timeFrame': '3 months', 'description': 'Changes of insulin resistance index at baseline prior to drug administration and at 3 months after the index PCI.'}, {'measure': 'Changes of platelet reactivity', 'timeFrame': '3 months', 'description': 'Changes of platelet reactivity at baseline prior to drug administration and at 3 months after the index PCI.'}, {'measure': 'Changes of fasting plasma glucose (FPG) level', 'timeFrame': '12 months', 'description': 'Changes of FPG level at baseline prior to drug administration and at 3 months after the index PCI.'}, {'measure': 'Changes of glycated hemoglobin (HbA1c)', 'timeFrame': '12 months', 'description': 'Changes of HbA1c at baseline prior to drug administration and at 12 months after the index PCI.'}, {'measure': 'Changes of plasma lipid parameters', 'timeFrame': '12 months', 'description': 'Changes of plasma lipid parameters including triglycerides, high-density lipoprotein cholesterol and low density lipoprotein cholesterol and total cholesterol at baseline prior to drug administration and at 12 months after the index PCI.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True}, 'conditionsModule': {'keywords': ['coronary artery disease', 'diabetes mellitus', 'percutaneous coronary intervention', 'SGLT-2 inhibitor', 'insulin resistance', 'platelet reactivity'], 'conditions': ['Coronary Artery Disease', 'Diabete Mellitus']}, 'descriptionModule': {'briefSummary': 'The study is to compare the effects of SGLT-2 inhibitors and other oral hypoglycemic agents in patients with coronary heart disease and diabetes mellitus undergoing percutaneous coronary intervention.', 'detailedDescription': 'This is a single center, observational study designed to evaluate the efficacy of SGLT-2 inhibitors and other oral hypoglycemic agents in patients with coronary heart disease and diabetes mellitus who underwent percutaneous coronary intervention (PCI). 1424 subjects will be enrolled. All patients were divided into the SGLT-2 inhibitors group and other oral hypoglycemic agents group according to whether they were discharged with SGLT-2 inhibitors or not. The primary endpoint is adverse cardiovascular and cerebrovascular events (MACCE), composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and unplanned coronary revascularization at 12 months after the index PCI. The key secondary endpoints are changes in insulin resistance index and platelet reactivity at 3 months and change in glucose and lipid metabolism at 12 months after the index PCI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with coronary heart disease and diabetes mellitus who underwent percutaneous coronary intervention.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years\n2. Patients with coronary heart disease and diabetes mellitus who underwent percutaneous coronary intervention.\n3. Patients were provided informed consent before the procedure.\n\nExclusion Criteria:\n\n1. History of diabetic ketoacidosis, type 1 diabetes, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy.\n2. History of one or more severe hypoglycemic episode within 6 months before screening\n3. Ongoing, inadequately controlled thyroid disorder.\n4. History of hepatitis B surface antigen or hepatitis C antibody positive\n5. Any history of or planned bariatric surgery.\n6. Current use of a corticosteroid medication or immunosuppressive agent, or likely to require treatment with a corticosteroid medication.'}, 'identificationModule': {'nctId': 'NCT05333159', 'briefTitle': 'The Efficacy of SGLT-2 Inhibitor in Patients With CAD and DM Undergoing PCI.', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Anzhen Hospital'}, 'officialTitle': 'Clinical Efficacy of SGLT-2 Inhibitor After Stent Implantation in Patients With Coronary Heart Disease and Diabetes Mellitus：a Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'KS2022016'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental', 'description': 'Subjects will be treated with SGLT-2 inhibitors (dapagliflozin, canagliflozin, empagliflozin) with or without conventional hypoglycemic drugs .', 'interventionNames': ['Drug: SGLT2 inhibitor']}, {'label': 'Control', 'description': 'Subjects will be only treated with conventional hypoglycemic drugs.'}], 'interventions': [{'name': 'SGLT2 inhibitor', 'type': 'DRUG', 'otherNames': ['dapagliflozin', 'canagliflozin', 'empagliflozin'], 'description': 'dapagliflozin 10mg once daily dose canagliflozin100mg once daily dose empagliflozin 0mg once daily dose', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'xiaofan Wu, MD', 'role': 'CONTACT', 'email': 'drwuxf@163.com', 'phone': '6445-6587'}], 'facility': 'Beijing Anzhen Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'xiaofan Wu, MD', 'role': 'CONTACT', 'email': 'drwuxf@163.com', 'phone': '6445-6587'}, {'name': 'Yue Wang, MD', 'role': 'CONTACT', 'email': '1091156087@qq.com', 'phone': '18910714716'}], 'overallOfficials': [{'name': 'xiaofan Wu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Anzhen Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Anzhen Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Xiaofan Wu', 'investigatorAffiliation': 'Beijing Anzhen Hospital'}}}}