Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-02-25 @ 4:16 AM
Study NCT ID:
NCT03622060
Status:
COMPLETED
Last Update Posted:
2019-06-04
First Post:
2018-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraarterial Nitroglycerin Versus Nicardipine and Radial Artery Occlusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D000783', 'term': 'Aneurysm'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005996', 'term': 'Nitroglycerin'}, {'id': 'D009529', 'term': 'Nicardipine'}], 'ancestors': [{'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double blind'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'nitroglycerin and nicardipine'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-05-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-01', 'studyFirstSubmitDate': '2018-08-01', 'studyFirstSubmitQcDate': '2018-08-04', 'lastUpdatePostDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The absence of antegrade radial artery flow by doppler evaluation', 'timeFrame': '24 hour', 'description': 'The absence of radial artery flow by doppler evaluation'}, {'measure': 'Blood pressure change', 'timeFrame': '2 minutes after drugs administration', 'description': 'Blood pressure change after drugs administration'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Radial Artery Injury at Wrist and Hand Level', 'Occlusion of Artery', 'Vasodilation']}, 'referencesModule': {'references': [{'pmid': '25179153', 'type': 'RESULT', 'citation': 'Dharma S, Kedev S, Patel T, Kiemeneij F, Gilchrist IC. A novel approach to reduce radial artery occlusion after transradial catheterization: postprocedural/prehemostasis intra-arterial nitroglycerin. Catheter Cardiovasc Interv. 2015 Apr;85(5):818-25. doi: 10.1002/ccd.25661. Epub 2014 Sep 13.'}]}, 'descriptionModule': {'briefSummary': 'A total of 600 patients undergoing coronary procedures via transradial access using 6F sheath were randomized at the end of the procedure to receive either 250-µg nicardipine or 500-µg nitroglycerin administered to the radial artery through the radial sheath before sheath removal. A continuous patent hemostasis was applied in each patient with the use of an oximetry to maintain an oxygen saturation of \\>95%, measured in the finger of the accessed arm until compression device was totally removed. The primary outcome is early RAO which was evaluated by color duplex ultrasonography of the accessed arteries at the day after the radial procedure. Secondary outcome was the change of blood pressure at 2-3 minutes after drug administration. Radial artery angiogram was performed after radial sheath insertion and doppler ultrasound of the accesed radial artery was examined at the day after the procedure.', 'detailedDescription': 'Doppler ultrasound of the accessed artery was performed at the day after the radial procedure in all patients. The absence or presence of antegrade flow in the radial artery will be examined while compressing the ulnar artery as previously described.\n\nThe internal lumen radial artery diameter was evaluated by doppler ultrasound as the distance between the inner walls of the artery by personnel that are blinded to the study protocol.\n\nRadial artery angiogram was performed soon after radial sheath insertion and the radial artery diameter was measured in AP projection in all patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients undergoing transradial catheterization\n\nExclusion Criteria:\n\n* Systolic blood pressure \\< 100 mmHg'}, 'identificationModule': {'nctId': 'NCT03622060', 'acronym': 'NONERAO', 'briefTitle': 'Intraarterial Nitroglycerin Versus Nicardipine and Radial Artery Occlusion', 'organization': {'class': 'OTHER', 'fullName': 'Hermina Heart Center Kemayoran'}, 'officialTitle': 'A Randomized Comparison of Post-procedural/Pre-hemostasis Intraarterial Nitroglycerin Versus Nicardipine to Reduce Radial Artery Occlusion After Transradial Catheterization', 'orgStudyIdInfo': {'id': 'HerminaHCK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nitroglycerin', 'description': '500 microgram intraarterial Nitroglycerin', 'interventionNames': ['Drug: Nitroglycerin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Nicardipine', 'description': '200 microgram intraraterial Nicardipine', 'interventionNames': ['Drug: Nitroglycerin']}], 'interventions': [{'name': 'Nitroglycerin', 'type': 'DRUG', 'otherNames': ['Nicardipine'], 'description': '200 microgram intraarterial nicardipine and 500 microgram nitroglycerin administered before sheath removal', 'armGroupLabels': ['Nicardipine', 'Nitroglycerin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10630', 'city': 'Jakarta Pusat', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'Hermina Heart Center', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}], 'overallOfficials': [{'name': 'Surya Dharma, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hermina Hospital Kemayoran'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hermina Heart Center Kemayoran', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hermina Hospital Group', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'NONERAO study', 'investigatorFullName': 'Surya Dharma, MD, PhD', 'investigatorAffiliation': 'Hermina Heart Center Kemayoran'}}}}