Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-02-25 @ 4:56 PM
Study NCT ID:
NCT03797651
Status:
UNKNOWN
Last Update Posted:
2023-03-07
First Post:
2019-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ticagrelor Monotherapy in PAtients Treated With New-generation Drug-eluting Stents for Acute Coronary Syndrome; T-PASS Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2850}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2025-04-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-03', 'studyFirstSubmitDate': '2019-01-06', 'studyFirstSubmitQcDate': '2019-01-06', 'lastUpdatePostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Net clinical benefit', 'timeFrame': '1 year after procedure', 'description': 'A composite of all-cause death, MI, stent thrombosis, stroke, major bleeding'}], 'secondaryOutcomes': [{'measure': 'Each components of net clinical benefit', 'timeFrame': '1 year after procedure', 'description': 'All-cause death, MI, stent thrombosis, stroke, major bleeding'}, {'measure': 'Cardiovascular mortality', 'timeFrame': '1 year after procedure', 'description': 'Cardiovascular mortality'}, {'measure': 'Major or minor bleeding', 'timeFrame': '1 year after procedure', 'description': 'Major or minor bleeding'}, {'measure': 'Major adverse cardiac event', 'timeFrame': '1 year after procedure', 'description': 'A composite of cardiac death, MI, stent thrombosis, ischemia-driven target-vessel revascularization'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease, Acute Coronary Syndrome']}, 'referencesModule': {'references': [{'pmid': '37878786', 'type': 'DERIVED', 'citation': 'Hong SJ, Lee SJ, Suh Y, Yun KH, Kang TS, Shin S, Kwon SW, Lee JW, Cho DK, Park JK, Bae JW, Kang WC, Kim S, Lee YJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Hong MK; T-PASS (Ticagrelor Monotherapy in Patients Treated With New-Generation Drug-Eluting Stents for Acute Coronary Syndrome) Investigators. Stopping Aspirin Within 1 Month After Stenting for Ticagrelor Monotherapy in Acute Coronary Syndrome: The T-PASS Randomized Noninferiority Trial. Circulation. 2024 Feb 20;149(8):562-573. doi: 10.1161/CIRCULATIONAHA.123.066943. Epub 2023 Oct 25.'}]}, 'descriptionModule': {'briefSummary': 'We hypothesized that ticagrelor monotherapy might be enough to prevent thromboembolic events without aspirin after PCI in patients with acute coronary syndrome(ACS). Moreover, ticagrelor monotherapy will reduce bleeding risk compared to DAPT with aspirin plus ticagrelor. We will also evaluate 1-year safety and efficacy of Orsiro stent for patient with acute coronary syndrome. After confirmation of enrollment, patients will be randomized to continue standard treatment (aspirin plus ticagrelor) for 1 year or to stop aspirin after discharge or less than 1 month after PCI (ticagrelor monotherapy). Randomization will be stratified according to 1) the presence of diabetes and 2) ST elevation myocardial infarction (MI). Baseline clinical and angiographic characteristics, laboratory findings will be assessed at the time of randomization. All patients will provide informed consent on their own initiative.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients ≥19 years old\n2. Patients who received new generation sirolimus-eluting (Orsiro® series) stent implantation for treating ACS, including acute MI and unstable angina\n3. Provision of informed consent\n\nExclusion Criteria:\n\n1. Age\\> 80 years\n2. Increased risk of bleeding, anemia, thrombocytopenia\n3. A need for oral anticoagulation therapy\n4. Pregnant women or women with potential childbearing\n5. Life expectancy \\< 1 year'}, 'identificationModule': {'nctId': 'NCT03797651', 'briefTitle': 'Ticagrelor Monotherapy in PAtients Treated With New-generation Drug-eluting Stents for Acute Coronary Syndrome; T-PASS Trial', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Ticagrelor Monotherapy in PAtients Treated With New-generation Drug-eluting Stents for Acute Coronary Syndrome; T-PASS Trial', 'orgStudyIdInfo': {'id': '4-2018-0782'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard DAPT', 'description': 'Patient will continue standard treatment (aspirin plus ticagrelor) for 1 year. Dosage of ticagrelor would be 90 mg twice a day, and 100 mg of aspirin will be prescribed once a day.', 'interventionNames': ['Drug: Standard DAPT']}, {'type': 'EXPERIMENTAL', 'label': 'Very-short DAPT within 1 month', 'description': 'Patient will stop aspirin after discharge (DAPT less than 1 months after PCI) (ticagrelor monotherapy). Dosage of ticagrelor would be 90 mg twice a day, and 100 mg of aspirin will be prescribed once a day (during hospitalization).', 'interventionNames': ['Drug: Very-short DAPT less than 1 month after PCI']}], 'interventions': [{'name': 'Standard DAPT', 'type': 'DRUG', 'description': 'Patient will continue standard treatment (aspirin plus ticagrelor) for 1 year. Dosage of ticagrelor would be 90 mg twice a day, and 100 mg of aspirin will be prescribed once a day.', 'armGroupLabels': ['Standard DAPT']}, {'name': 'Very-short DAPT less than 1 month after PCI', 'type': 'DRUG', 'description': 'Patient will stop aspirin (ticagrelor monotherapy) after discharge or within 1 month. Dosage of ticagrelor would be 90 mg twice a day, and 100 mg of aspirin will be prescribed once a day (during hospitalization).', 'armGroupLabels': ['Very-short DAPT within 1 month']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Myeong-Ki Hong, MD, PhD', 'role': 'CONTACT', 'email': 'mkhong61@yuhs.ac', 'phone': '82-2-2228-8458'}], 'facility': 'Yonsei Cardiovascular Center and Cardiovascular Research Institute, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Myeong-Ki Hong, MD, PhD', 'role': 'CONTACT', 'email': 'mkhong61@yuhs.ac', 'phone': '82-2-2228-8458'}], 'overallOfficials': [{'name': 'Myeong-Ki Hong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Cardiology, Severance Hospital, Yonsei University College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}