Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-02-24 @ 12:13 AM
Study NCT ID:
NCT01878669
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-20
First Post:
2013-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of N-acetyl Cysteine During Percutaneous Coronary Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000111', 'term': 'Acetylcysteine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 390}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-17', 'studyFirstSubmitDate': '2013-03-26', 'studyFirstSubmitQcDate': '2013-06-12', 'lastUpdatePostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'periprocedural myocardial infarction', 'timeFrame': 'postprocedural 3-6 h'}], 'secondaryOutcomes': [{'measure': 'NAC side effects (Asthma exacerbation, pruritus, dyspnea)', 'timeFrame': 'during hospitalization at 48 hours'}, {'measure': 'major cardiac and cerebral events', 'timeFrame': '1 year follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['n-acetyl cysteine', 'percutaneous coronary intervention'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effects of N-acetyl cysteine on periprocedural myocardial infarction and major cardiac and cerebral events in patients undergoing percutaneous coronary intervention and who have moderate to high risk for contrast induced nephropathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\> 18 years old undergoing percutaneous coronary intervention and who have moderate to high risk for contrast induced nephropathy (Mehran Score ≥ 5)\n\nExclusion Criteria:\n\n* Primary percutaneous coronary intervention\n* Low risk for contrast induced nephropathy (Mehran Score \\< 5)\n* Use of nephrotoxic agents (NSAIDs, aminoglycosides,recent contrast injection...)\n* Infection\n* Pregnancy, Lactation\n* Renal failure requiring dialysis\n* Hepatic failure\n* History allergy for NAC\n* History of Asthma\n* Chronic nitrate usage\n* Malignancy\n* Use of corticosteroids\n* Leukocytosis,Thrombocytosis,Anemia\n* Blood pressure of \\>180/100mmHg despite anti-hypertensive therapy'}, 'identificationModule': {'nctId': 'NCT01878669', 'acronym': 'EASE-PCI', 'briefTitle': 'Effects of N-acetyl Cysteine During Percutaneous Coronary Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Suleyman Demirel University'}, 'officialTitle': 'Effects of N-acetyl Cysteine on Periprocedural Myocardial Infarction and Major Cardiac and Cerebral Events in Patients Undergoing Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': 'ozaydin289'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'saline', 'description': '30 mg/kg/15 min intravenous bolus preprocedural and 50 mg/kg/8 h intravenous infusion during and after the procedure', 'interventionNames': ['Drug: Saline']}, {'type': 'EXPERIMENTAL', 'label': 'n-acetyl cysteine', 'description': '30 mg/kg/15 min intravenous bolus preprocedural and 50 mg/kg/8 h intravenous infusion during and after the procedure', 'interventionNames': ['Drug: N-acetyl cysteine']}], 'interventions': [{'name': 'N-acetyl cysteine', 'type': 'DRUG', 'armGroupLabels': ['n-acetyl cysteine']}, {'name': 'Saline', 'type': 'DRUG', 'armGroupLabels': ['saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32260', 'city': 'Isparta', 'state': 'Mediterranean Region', 'country': 'Turkey (Türkiye)', 'facility': 'Suleyman Demirel University', 'geoPoint': {'lat': 37.76444, 'lon': 30.55222}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suleyman Demirel University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Professor', 'investigatorFullName': 'Mehmet Ozaydin, MD', 'investigatorAffiliation': 'Suleyman Demirel University'}}}}