Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-01-01 @ 1:53 AM
Study NCT ID:
NCT05435235
Status:
SUSPENDED
Last Update Posted:
2024-07-31
First Post:
2022-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dapagliflozin in the Prevention of Post-Coronary Angioplasty Acute Kidney Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C529054', 'term': 'dapagliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'whyStopped': 'Laboratory UNGAL', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-30', 'studyFirstSubmitDate': '2022-06-23', 'studyFirstSubmitQcDate': '2022-06-23', 'lastUpdatePostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute Kidney Injury', 'timeFrame': 'Within 7 days.', 'description': 'According to the Kidney Disease Improving Global Outcomes (KDIGO) 2012 definition: increase in serum creatinine by ≥ 0.3 mg/dl (≥ 26.5 μmol/l) within 48 hours or increase in serum creatinine (SCr) to ≥ 1.5 times the known baseline which is known or presumed to have occurred within the prior 7 days.\n\nWe will measure Urine Neutrophil Gelatinase-associated Lipocalin (UNGAL) at least 6 hours post-PCI and Serum Creatinine at follow up within 7 days.'}], 'secondaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': '7 days', 'description': 'Days'}, {'measure': 'Incidence of genitourinary infections', 'timeFrame': '7 days', 'description': 'Symptomatic pyuria or new vaginal infection.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SGLT2 inhibitor', 'Dapagliflozin', 'AKI', 'PCI', 'Angiography'], 'conditions': ['Acute Kidney Injury', 'Percutaneous Coronary Intervention']}, 'descriptionModule': {'briefSummary': 'To compare the incidence of acute kidney injury (AKI) post percutaneous coronary intervention (PCI) in a Dapagliflozin treated group versus a group managed with the usual standard of care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 years or more.\n2. Scheduled/non-emergent Percutaneous coronary intervention (PCI).\n3. Post-index procedure Staged PCI with at least 14 days from contrast exposure.\n4. Patient can fully understand the study information and sign informed consent.\n\nExclusion Criteria:\n\n1. Cardiogenic shock /need for inotrope or mechanical pump support.\n2. Acute kidney injury as defined by KDIGO criteria (\\<4 weeks) prior to PCI.\n3. End-Stage Renal Disease prior to PCI (On renal replacement therapy).\n4. Diabetes Mellitus type 1.\n5. Active diabetic ketoacidosis or uncontrolled hyperglycemia (blood glucose \\>400 mg/dl).\n6. ST-segment elevation Myocardial Infarction undergoing index PCI.\n7. Active Genitourinary infection.\n8. Diagnostic Left Heart Catheterization without PCI.\n9. Patients undergoing zero contrast PCI.\n10. Participation in a randomized controlled pharmaceutical or treatment-related cardiac or pulmonary clinical study within 1 month prior to randomization.\n11. Coexistent hemodynamically significant valvulopathy (Symptomatic and/or severe).\n12. Patients with Acute Heart Failure admission \\< 30 days prior to PCI.\n13. Intercurrent illness resulting in volume depletion and hypotension (MAP\\<60 mmHg).\n14. Patients with a kidney transplant.\n15. Any contrast exposure within 14 days.\n16. Patients with estimated glomerular filtration rate (eGFR) \\< 25 cc/min (Recommended eGFR threshold by Food and Drug Administration labeling).\n17. Patients with an active intrinsic inflammatory or autoimmune renal pathology.\n18. Women of child bearing age (\\<50 years old).\n19. Prison Inmates'}, 'identificationModule': {'nctId': 'NCT05435235', 'acronym': 'DAPA-PCI-AKI', 'briefTitle': 'Dapagliflozin in the Prevention of Post-Coronary Angioplasty Acute Kidney Injury', 'organization': {'class': 'OTHER', 'fullName': 'Albert Einstein Healthcare Network'}, 'officialTitle': 'Dapagliflozin in the Prevention of Post-Coronary Intervention Acute Kidney Injury', 'orgStudyIdInfo': {'id': '2022-864'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dapagliflozin arm', 'description': 'Patients who received Dapagliflozin 10 mg daily starting 48h prior to PCI and continuing for 48h post-PCI.', 'interventionNames': ['Drug: Dapagliflozin 10mg Tab']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care', 'description': 'Patients who received the standard of care.'}], 'interventions': [{'name': 'Dapagliflozin 10mg Tab', 'type': 'DRUG', 'description': 'One tablet daily starting 48h prior to PCI and continuing for 48h post-PCI.', 'armGroupLabels': ['Dapagliflozin arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19141', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Einstein Medical Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albert Einstein Healthcare Network', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Cardiologist and Director of Academics, Cardiology', 'investigatorFullName': 'Gregg Pressman', 'investigatorAffiliation': 'Albert Einstein Healthcare Network'}}}}