Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-01 @ 11:41 AM
Study NCT ID:
NCT04989257
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-08-04
First Post:
2021-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
24-month Ticagrelor-based Dual-antiplatelet Therapy Versus Clopidogrel-based Dual-antiplatelet theRapy aftEr 12 Months of DrUg-eluting Stent Implantation in High isChEmic Risk Patients: P-REDUCE Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Ticagrelor-based dual-antiplatelet therapy vs. Clopidogrel-based dual-antiplatelet therapy'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3488}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-03', 'studyFirstSubmitDate': '2021-07-01', 'studyFirstSubmitQcDate': '2021-08-03', 'lastUpdatePostDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of all-cause death, myocardial infarction, or stroke', 'timeFrame': 'up to 24 months', 'description': 'Composite of all-cause death, myocardial infarction, or stroke at 24 months after randomization'}], 'secondaryOutcomes': [{'measure': 'BARC type 2, 3, or 5 bleeding', 'timeFrame': 'up to 24 months', 'description': 'BARC type 2, 3, or 5 bleeding at 24 months after randomization'}, {'measure': 'All-cause death', 'timeFrame': 'up to 24 months', 'description': 'All-cause death at 24 months after randomization'}, {'measure': 'Myocardial infarction', 'timeFrame': 'up to 24 months', 'description': 'Myocardial infarction at 24 months after randomization'}, {'measure': 'Stroke', 'timeFrame': 'up to 24 months', 'description': 'Stroke at 24 months after randomization'}, {'measure': 'Cardiac death', 'timeFrame': 'up to 24 months', 'description': 'Cardiac death at 24 months after randomization'}, {'measure': 'Composite of all-cause death, myocardial infarction, stroke, or BARC type 2, 3, or 5 bleeding', 'timeFrame': 'up to 24 months', 'description': 'Composite of all-cause death, myocardial infarction, stroke, or BARC type 2, 3, or 5 bleeding at 24 months after randomization'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['High Ischemic Risk']}, 'descriptionModule': {'briefSummary': 'The purpose of this prospective randomized clinical trial is to compare the clinical outcomes between aspirin with ticagrelor versus aspirin with clopidogrel in high ischemic risk patients beyond 12 months after percutaneous coronary intervention with drug-eluting stent implantation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥50 years old\n2. History of drug-eluting stent implantation due to acute myocardial infarction 12 to 24 months ago\n3. High-risk for ischemic events (at least one of the following) 1) Age \\>65 years old 2) Medical treatments for diabetes mellitus 3) Multi-vessel coronary artery disease 4) More than 2 episodes of myocardial infarction 5) Chronic kidney disease (stage III or IV)\n\nExclusion Criteria:\n\n1. Age ≥85 years old\n2. Pregnant women or women with potential childbearing\n3. Life expectancy \\< 1 year\n4. Inability to understand or read the informed consent\n5. Need for long-term anticoagulation therapy'}, 'identificationModule': {'nctId': 'NCT04989257', 'briefTitle': '24-month Ticagrelor-based Dual-antiplatelet Therapy Versus Clopidogrel-based Dual-antiplatelet theRapy aftEr 12 Months of DrUg-eluting Stent Implantation in High isChEmic Risk Patients: P-REDUCE Trial', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': '24-month Ticagrelor-based Dual-antiplatelet Therapy Versus Clopidogrel-based Dual-antiplatelet theRapy aftEr 12 Months of DrUg-eluting Stent Implantation in High isChEmic Risk Patients: P-REDUCE Trial', 'orgStudyIdInfo': {'id': '4-2021-0591'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ticagrelor-based dual-antiplatelet therapy', 'description': 'Aspirin with ticagrelor', 'interventionNames': ['Drug: Ticagrelor-based dual-antiplatelet therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Clopidogrel-based dual-antiplatelet therapy', 'description': 'Aspirin with clopidogrel', 'interventionNames': ['Drug: Clopidogrel-based dual-antiplatelet therapy']}], 'interventions': [{'name': 'Ticagrelor-based dual-antiplatelet therapy', 'type': 'DRUG', 'description': 'Aspirin with ticagrelor', 'armGroupLabels': ['Ticagrelor-based dual-antiplatelet therapy']}, {'name': 'Clopidogrel-based dual-antiplatelet therapy', 'type': 'DRUG', 'description': 'Aspirin with clopidogrel', 'armGroupLabels': ['Clopidogrel-based dual-antiplatelet therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Byeong-Keuk Kim', 'role': 'CONTACT', 'email': 'kimbk@yuhs.ac', 'phone': '82-2-2228-8460'}], 'facility': 'Severance Hospital, Yonsei University Health System', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Byeong-Keuk Kim', 'role': 'CONTACT', 'email': 'kimbk@yuhs.ac', 'phone': '82-2-2228-8460'}], 'overallOfficials': [{'name': 'Byeong-Keuk Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yonsei University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}