Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT05559918
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2022-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dual-antiplatelet Therapy Strategies for Elective PCI in a Real-world Setting
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1462}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-23', 'studyFirstSubmitDate': '2022-09-21', 'studyFirstSubmitQcDate': '2022-09-26', 'lastUpdatePostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Net adverse clinical events (NACE)', 'timeFrame': '30 days', 'description': 'The incidence rate of NACE (the composite of the clinical events all-cause death, myocardial infarction, definite/probable stent thrombosis, stroke and BARC type 2, -3 or -5 bleeding) wil be compared between groups at 30 days'}], 'secondaryOutcomes': [{'measure': 'Bleeding (classified as BARC type 2, -3 and -5 bleeding)', 'timeFrame': 'In-hospital, at 30 days', 'description': 'The incidence rate of bleeding (classified as BARC type 2, -3 and -5 bleeding) will be compared between groups'}, {'measure': 'Patient oriented clinical events (POCE)', 'timeFrame': 'In-hospital, at 30 days', 'description': 'The incidence rate of POCE (the composite of clinical events all-cause death, stroke, myocardial infarction, and repeat revascularization) will be compared between groups'}, {'measure': 'All-cause mortality', 'timeFrame': 'In-hospital, at 30 days', 'description': 'The incidence rate of all-cause mortality will be compared between groups'}, {'measure': 'Myocardial infarction', 'timeFrame': 'In-hospital, at 30 days', 'description': 'The incidence rate of myocardial infarction will be compared between groups'}, {'measure': 'Stent thrombosis (definite/probable)', 'timeFrame': 'In-hospital, at 30 days', 'description': 'The incidence rate of stent thrombosis (definite and probable) will be compared between groups'}, {'measure': 'Stroke', 'timeFrame': 'In-hospital, at 30 days', 'description': 'The incidence rate of stroke will be compared between groups'}, {'measure': 'Repeat revascularisation', 'timeFrame': 'In-hospital, at 30 days', 'description': 'The incidence rate of repeat revascularisation will be compared between groups'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pretreatment', 'Diagnostic angiography', 'ad-hoc PCI'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'To assess the safety and efficacy of in-laboratory clopidogrel loading dose administration before ad-hoc PCI versus clopidogrel preloading treatment in patients planned for diagnostic angiography with optional ad-hoc PCI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients aged 18 years and older who have been referred for diagnostic CAG due to symptoms suggestive of obstructive coronary artery disease with optional ad-hoc PCI.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult men and women aged at least 18 years\n* Scheduled for diagnostic CAG due to suspected obstructive coronary artery disease\n\nExclusion Criteria:\n\n* Presence of contra-indications for the use of clopidogrel (hypersensitivity or known allergy to clopidogrel, severe liver insufficiency, resent or active pathological bleeding, patients known to be poor CYP2C19 metabolizers, patients using pharmacological CYP2C19 inhibitors and inducers)\n* Patients using clopidogrel for other reasons than the scheduled diagnostic CAG (e.g. due to previous stroke)\n* Patients using P2Y12 inhibitors other than clopidogrel (e.g. prasugrel, ticagrelor, cangrelor)\n* Patients using VKA (e.g. acenocoumarol, fenprocoumon)\n* Patients using DOAC/NOAC (e.g. apixaban, dabigatran, edoxaban, rivaroxaban)\n* Inability to give informed consent (e.g., language barrier)\n* Patients who have a documented mentioning of previous denial to any trial participation in the electronic patient dossier'}, 'identificationModule': {'nctId': 'NCT05559918', 'acronym': 'DAPT-FOR-REAL', 'briefTitle': 'Dual-antiplatelet Therapy Strategies for Elective PCI in a Real-world Setting', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'Dual-antiplatelet Therapy Strategies for Elective PCI in a Real-world Setting', 'orgStudyIdInfo': {'id': 'AUMC25485'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Preloading with clopidogrel'}, {'label': 'In-hospital loading with clopidogrel'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amsterdam', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Ronak Delewi, MD PhD', 'role': 'CONTACT', 'email': 'r.delewi@amsterdamumc.nl'}], 'facility': 'Amsterdam Universitair Medisch Centrum (AUMC) - Locatie AMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Amsterdam', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Niels Verouden, MD PhD', 'role': 'CONTACT', 'email': 'c.verouden@amsterdamumc.nl'}], 'facility': 'Amsterdam Universitair Medisch Centrum (AUMC) - Locatie VUMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'centralContacts': [{'name': 'Ronak Delewi, MD, PhD', 'role': 'CONTACT', 'email': 'r.delewi@amsterdamumc.nl', 'phone': '+31(0)20 566 9111'}], 'overallOfficials': [{'name': 'Ronak Delewi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Amsterdam University Medical Center, location AMC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator Dr. R Delewi', 'investigatorFullName': 'Ronak Delewi', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}