Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-01-01 @ 7:46 AM
Study NCT ID:
NCT05997693
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2023-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
One-Month DAPT in CABG Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077486', 'term': 'Ticagrelor'}, {'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D000241', 'term': 'Adenosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2031-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-19', 'studyFirstSubmitDate': '2023-07-26', 'studyFirstSubmitQcDate': '2023-08-11', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hierarchical composite of time to death, stroke, myocardial infarction, repeat revascularization and any graft failure.', 'timeFrame': '1 year', 'description': 'This is a composite endpoint to be compared between groups in a hierarchical order using the win ratio method. The following hierarchy is pre-specified:\n\n1. Time to all-cause mortality\n2. Time to stroke\n3. Time to myocardial infarction\n4. Time to coronary revascularization\n5. Presence of graft failure at 12-month imaging follow-up or on unscheduled imaging prior to 12 month'}], 'secondaryOutcomes': [{'measure': 'Hierarchical composite of time to death, stroke, myocardial infarction, Bleeding Academic Research Consortium (BARC) type 3 bleeding, repeat revascularization and any graft failure.', 'timeFrame': '1 year', 'description': 'This is a composite endpoint to be compared between groups in a hierarchical order using the win ratio method. The following hierarchy is pre-specified:\n\n1. Time to all-cause mortality\n2. Time to stroke\n3. Time to myocardial infarction\n4. Time to BARC 3 bleeding\n5. Time to coronary revascularization\n6. Presence of graft failure at 12-month imaging follow-up'}, {'measure': 'Hierarchical composite of time to death, stroke, myocardial infarction, repeat revascularization and 5-year time-averaged disease-specific (Seattle Angina Questionnaire [SAQ]-7) quality of life (QoL) score', 'timeFrame': '5 years', 'description': 'This is a composite endpoint to be compared between groups in a hierarchical order using the win ratio method. The following hierarchy is pre-specified:\n\n1. Time to all-cause mortality\n2. Time to stroke\n3. Time to myocardial infarction\n4. Time to coronary revascularization\n5. 5-year time-averaged disease-specific QOL (SAQ-7) score'}, {'measure': 'Hierarchical composite of time to death, stroke, myocardial infarction, BARC type 3 bleeding, repeat revascularization and 5-year time-averaged SAQ-7 QoL score.', 'timeFrame': '5 years', 'description': 'This is a composite endpoint to be compared between groups in a hierarchical order using the win ratio method. The following hierarchy is pre-specified:\n\n1. Time to all-cause mortality\n2. Time to stroke\n3. Time to myocardial infarction\n4. Time to BARC 3 bleeding\n5. Time to coronary revascularization\n6. 5-year time-averaged disease-specific QOL (SAQ-7) score'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Coronary Disease']}, 'referencesModule': {'references': [{'pmid': '35943473', 'type': 'BACKGROUND', 'citation': 'Sandner S, Redfors B, Angiolillo DJ, Audisio K, Fremes SE, Janssen PWA, Kulik A, Mehran R, Peper J, Ruel M, Saw J, Soletti GJ, Starovoytov A, Ten Berg JM, Willemsen LM, Zhao Q, Zhu Y, Gaudino M. Association of Dual Antiplatelet Therapy With Ticagrelor With Vein Graft Failure After Coronary Artery Bypass Graft Surgery: A Systematic Review and Meta-analysis. JAMA. 2022 Aug 9;328(6):554-562. doi: 10.1001/jama.2022.11966.'}, {'pmid': '38436365', 'type': 'DERIVED', 'citation': 'Sandner S, Gaudino M, Redfors B, Angiolillo DJ, Ben-Yehuda O, Bhatt DL, Fremes SE, Lamy A, Marano R, Mehran R, Pocock S, Rao SV, Spertus JA, Weinsaft JW, Wells G, Ruel M. One-month DAPT with ticagrelor and aspirin for patients undergoing coronary artery bypass grafting: rationale and design of the randomised, multicentre, double-blind, placebo-controlled ODIN trial. EuroIntervention. 2024 Mar 4;20(5):e322-e328. doi: 10.4244/EIJ-D-23-00699.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effect of ticagrelor plus low-dose aspirin versus low-dose aspirin alone in patients with chronic coronary disease undergoing coronary artery bypass grafting.', 'detailedDescription': 'A multinational, randomized trial to evaluate the effect of one-month of ticagrelor plus low-dose aspirin, versus low-dose aspirin alone, on the incidence of death, myocardial infarction, stroke, repeat revascularization and graft failure in patients with chronic coronary disease undergoing coronary artery bypass grafting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Elective first-time CABG with use of ≥1 saphenous vein graft;\n* Ability to sign informed consent and comply with all study procedures, including follow-up for at least 5 years.\n\nExclusion Criteria:\n\n* Any indication for dual antiplatelet therapy, including\n\n * Acute/recent (within 1 year) ACS (NSTE-ACS or STEMI)\n * Recent PCI requiring continuation of dual antiplatelet therapy after CABG\n* Current or anticipated use of oral anticoagulation;\n* Paroxysmal, persistent or permanent atrial fibrillation;\n* Any concomitant cardiac or non-cardiac procedure;\n* Planned cardiac or non-cardiac surgery within one year;\n* Preoperative end-organ dysfunction (dialysis, moderate to severe liver failure, respiratory failure), cancer or other non-cardiac comorbidity with a life expectancy \\<5 years;\n* Inability to use the saphenous vein;\n* Contraindications to the use of aspirin;\n* Contraindications to the use of ticagrelor, including\n\n * Known hypersensitivity to ticagrelor\n * Active pathological bleeding (including, but not limited to gastrointestinal or intracranial bleeding)\n * History of intracranial hemorrhage\n * Concomitant therapy with strong CYP3A4 inhibitors (eg ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir)\n* Inability to undergo coronary computed tomographic angiography (CCTA);\n* Participating in another investigational device or drug study;\n* Women of childbearing potential\n* Any major perioperative complication including, but not limited to, stroke, TIA, MI, CABG-related bleeding (BARC type 4), sepsis.'}, 'identificationModule': {'nctId': 'NCT05997693', 'acronym': 'ODIN', 'briefTitle': 'One-Month DAPT in CABG Patients', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'One Month Dual Antiplatelet Therapy With Ticagrelor in Coronary Artery Bypass Graft Patients', 'orgStudyIdInfo': {'id': '23-06026202'}, 'secondaryIdInfos': [{'id': '2023-506613-22', 'type': 'EUDRACT_NUMBER'}, {'id': '488058', 'type': 'OTHER_GRANT', 'domain': 'Canadian Institutes of Health Research (CIHR)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ticagrelor 90 mg + Low-Dose Aspirin', 'interventionNames': ['Drug: Ticagrelor 90 MG', 'Drug: Low-dose aspirin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low-Dose Aspirin Alone', 'interventionNames': ['Drug: Low-dose aspirin']}], 'interventions': [{'name': 'Ticagrelor 90 MG', 'type': 'DRUG', 'description': 'Ticagrelor 90 mg twice daily taken orally for one month', 'armGroupLabels': ['Ticagrelor 90 mg + Low-Dose Aspirin']}, {'name': 'Low-dose aspirin', 'type': 'DRUG', 'description': '75-150 mg once daily taken orally', 'armGroupLabels': ['Low-Dose Aspirin Alone', 'Ticagrelor 90 mg + Low-Dose Aspirin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07631', 'city': 'Englewood', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Molly Schultheis, MD', 'role': 'CONTACT', 'email': 'Molly.Schultheis@EHMCHealth.org', 'phone': '201-894-5670'}, {'name': 'Molly Schultheis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Englewood Hospital', 'geoPoint': {'lat': 40.89288, 'lon': -73.97264}}, {'zip': '11355', 'city': 'Flushing', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Charles A Mack, MD', 'role': 'CONTACT', 'email': 'cmack@med.cornell.edu', 'phone': '718-670-2400'}, {'name': 'Charles A Mack, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NewYork-Presbyterian: Queens Hospital', 'geoPoint': {'lat': 40.76538, 'lon': -73.81736}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mario Gaudino, MD PhD', 'role': 'CONTACT', 'email': 'mfg9004@med.cornell.edu', 'phone': '+1 212 746 1815'}, {'name': 'Mario Gaudino, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Weill Cornell Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '6020', 'city': 'Innsbruck', 'state': 'Innsbruck', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Elfriede Ruttmann-Ulmer', 'role': 'CONTACT', 'email': 'Elfriede.Ruttmann@i-med.ac.at', 'phone': '0043 512 504 80808'}, {'name': 'Elfriede Ruttmann-Ulmer', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical University Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'city': 'Graz', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Günther Laufer', 'role': 'CONTACT', 'email': 'guenther.laufer@medunigraz.at', 'phone': '0043-316-385-82820'}, {'name': 'Günther Laufer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical University Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'city': 'Linz', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Andreas Zierer', 'role': 'CONTACT', 'email': 'andreas.zierer@kepleruniklinikum.at', 'phone': '43 (0)57680 832136'}, {'name': 'Andreas Zierer', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Johannes Kepler University Linz', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '1090', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Sigrid Sandner, MD, MSCE', 'role': 'CONTACT', 'email': 'sigrid.sandner@meduniwien.ac.at', 'phone': '0043 1 40400 6989'}, {'name': 'Sigrid Sandner, MD, MSCE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': 'K1Y 4W7', 'city': 'Ottawa', 'state': 'Ontario', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Marc Ruel, MD, MPH', 'role': 'CONTACT', 'email': 'mruel@ottawaheart.ca'}, {'name': 'Marc Ruel, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Ottawa Heart Institute', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': '200023', 'city': 'Shanghai', 'state': 'China', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qiang Zhao, MD', 'role': 'CONTACT', 'email': 'zq11607@rjh.com.cn'}, {'name': 'Qiang Zhao, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ruijin Hospital: Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Changchun', 'state': 'Jilian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Massimo Lemma, MD, PhD', 'role': 'CONTACT', 'email': 'dr.lemma@jlheart.org', 'phone': '18644936793'}, {'name': 'Massimo Lemma, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Jilin Heart Hospital', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '100029', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ran Dong', 'role': 'CONTACT', 'email': 'dongran6618@hotmail.com', 'phone': '+86-139-1041-0620'}, {'name': 'Ran Dong', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Anzhen Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhaoyun Cheng', 'role': 'CONTACT', 'email': 'chengzhy@zzu.edu.cn', 'phone': '+86 13903712068'}, {'name': 'Zhaoyun Cheng', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Center China Fuwai Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Düsseldorf', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Alexander Assmann', 'role': 'CONTACT', 'email': 'Alexander.Assmann@med.uni-duesseldorf.de', 'phone': '+49-(0)211-81-18331'}, {'name': 'Alexander Assmann', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital of Düsseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Essen', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Matthias Thielmann', 'role': 'CONTACT'}, {'name': 'Matthias Thielmann', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Westdeutsches Herz- und Gefäßzentrum Essen, Universität Duisburg-Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Freiburg im Breisgau', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Alicja Zientara', 'role': 'CONTACT'}, {'name': 'Martin Czerny', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Klinik für Herz- und Gefäßchirurgie - Universitäts-Herzzentrum Freiburg - Bad Krozingen', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '35043', 'city': 'Giessen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Andreas Böning', 'role': 'CONTACT', 'email': 'andreas.boening@chiru.med.uni-giessen.de', 'phone': '0641-985-56242'}, {'name': 'Andreas Böning', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Giessen', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'city': 'Jena', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Torsten Doenst, MD', 'role': 'CONTACT'}, {'role': 'CONTACT', 'email': 'doenst@med.uni-jena.de', 'phone': '49 3641 9322901'}, {'name': 'Torsten Doenst, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Jena University Hospital', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'city': 'München', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christian Hagl', 'role': 'CONTACT'}, {'name': 'Christian Hagl', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'LMU Klinikum Campus Großhadern', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Stuttgart', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Marc Albert', 'role': 'CONTACT'}, {'name': 'Marc Albert', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Robert-Bosch-Krankenhaus Stuttgart', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '413 45', 'city': 'Gothenburg', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Anders Jeppsson, MD, PhD', 'role': 'CONTACT', 'email': 'anders.jeppsson@vgregion.se', 'phone': '0046-31-3427515'}, {'name': 'Anders Jeppsson, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Gothenburg', 'status': 'NOT_YET_RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Bjorn Redfors, MD, PhD', 'role': 'CONTACT'}, {'name': 'Bjorn Redfors, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sahlgrenska University Hospital Sweden', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '214 28', 'city': 'Malmo', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Igor Zindovic, MD', 'role': 'CONTACT', 'email': 'igor.zindovic@med.lu.se', 'phone': '0046-46-175288'}, {'name': 'Igor Zindovic, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Skåne University Hospital', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}], 'centralContacts': [{'name': 'Trisha Ali-Shaw', 'role': 'CONTACT', 'email': 'tra2002@med.cornell.edu', 'phone': '646-962-8281'}], 'overallOfficials': [{'name': 'Marc Ruel, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ottawa Heart Institute Research Corporation'}, {'name': 'Mario Gaudino, MD, PhD, MSCE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}