Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-03-04 @ 12:45 AM
Study NCT ID:
NCT04538534
Status:
COMPLETED
Last Update Posted:
2022-02-08
First Post:
2020-05-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nicardipine to Avoid Spasm in Trans Radial Percutaneous Coronary Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009529', 'term': 'Nicardipine'}], 'ancestors': [{'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-06', 'studyFirstSubmitDate': '2020-05-31', 'studyFirstSubmitQcDate': '2020-08-30', 'lastUpdatePostDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants in which radial artery spasm occurred', 'timeFrame': '24 hours', 'description': 'Significant limitation of the catheter movement perceived by the operator together with mild to severe pain in the forearm of the patient or the need of repeating vasodilator administration'}], 'secondaryOutcomes': [{'measure': 'Number of Participants in which severe radial artery spasm occurred', 'timeFrame': '24 hours', 'description': 'Complete catheter blockage \\[i.e., the catheter cannot be moved back or forth\\], severe pain with need for morphine or midazolam injections, crossover to the contralateral radial or femoral artery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['radial artery spasm'], 'conditions': ['Spasm Artery']}, 'descriptionModule': {'briefSummary': 'Radial artery is the recommended route for percutaneous coronary intervention for it significantly reduces net adverse clinical events compared to the femoral approach. The success of the radial approach is therefore of a paramount importance. However, radial artery spasm (RAS) remains one of the major limitations of transradial approach (TRA) and the most frequent cause of TRA failure. Several recommendations has been issued to improve success rate when using the radial route.\n\nIn the Tunisian difficult economic context, the use of low end equipment, the unavailability of nitroglycerine and calcium antagonist verapamil, has led to the general feeling that RAS and TRA failure has subsequently increased.\n\nThe standard and only used protocol by the Tunisian interventional cardiologist, consists of administrating 1 mg isosorbide dinitrate through the arterial sheath immediately after radial arterial puncture, therefore limiting the options to prevent RAS.\n\nNicardipine is the only injectable calcium antagonist available in Tunisia. Its spasmolytic action on radial artery has been well demonstrated when used in CABG. However, it has been very poorly investigated in trans radial percutaneous coronary intervention.\n\nInvestigators believe that the concomitant use of nicardipine with isorbide might significantly reduce RAS and TRA failure when compared to isosorbide dinitrate only.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients scheduled for coronary intervention will be eligible for screening (coronarography or coronary angioplasty).\n* Participant is willing and is able to give informed consent for participating in the trial.\n* Male or Female, aged 18 years or above.\n\nExclusion Criteria:\n\n* Planned femoral approach because no radial pulse was perceived\n* Cardiogenic shock\n* Coronary intervention for ST elevation myocardial infarction during the night shift.'}, 'identificationModule': {'nctId': 'NCT04538534', 'briefTitle': 'Nicardipine to Avoid Spasm in Trans Radial Percutaneous Coronary Intervention', 'organization': {'class': 'OTHER', 'fullName': 'University of Monastir'}, 'officialTitle': 'Nicardipine to Avoid Spasm in Trans Radial Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': 'TN2020-NA T -INS-39'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'nicardipine and isosorbide dinitrate', 'description': 'A Cocktail of 1 mg of Isosorbide Dinitrate associated to 1 mg of nicardipine will be put in a syringe than diluted in saline serum to have a volume of 3cc.\n\nThe obtained solution will be administered in an intra-arterial fashion via the trans-radial sheath after randomization.', 'interventionNames': ['Drug: Nicardipine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'isosorbide dinitrate', 'description': 'Isosorbide Dinitrate: 1 mg will be diluted in saline solution as to have a 3cc volume The obtained solution will be administered in an intra-arterial fashion via the trans-radial sheath after randomization', 'interventionNames': ['Drug: Nicardipine']}], 'interventions': [{'name': 'Nicardipine', 'type': 'DRUG', 'otherNames': ['Loxen'], 'description': 'To compare the association of nicardipine and isosorbide dinitrate vs isosorbide dinitrate alone on the rate of occurrence of radial artery spasm', 'armGroupLabels': ['isosorbide dinitrate', 'nicardipine and isosorbide dinitrate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Monastir', 'country': 'Tunisia', 'facility': 'CHU Fattouma Bourguiba', 'geoPoint': {'lat': 35.77799, 'lon': 10.82617}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pr. Semir Nouira', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Pr. Semir Nouira', 'investigatorAffiliation': 'University of Monastir'}}}}