One-Month DAPT in CABG Patients

Официальное название

One Month Dual Antiplatelet Therapy With Ticagrelor in Coronary Artery Bypass Graft Patients

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Ticagrelor 90 MG
  Ticagrelor 90 mg twice daily taken orally for one month
• Препарат Low-dose aspirin
  75-150 mg once daily taken orally

Первичные конечные точки

• Hierarchical composite of time to death, stroke, myocardial infarction, repeat revascularization and any graft failure. [Срок оценки: 1 year]

Вторичные конечные точки (3)

• Hierarchical composite of time to death, stroke, myocardial infarction, Bleeding Academic Research Consortium (BARC) type 3 bleeding, repeat revascularization and any graft failure. [Срок оценки: 1 year]
• 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 [Срок оценки: 5 years]
• Hierarchical composite of time to death, stroke, myocardial infarction, BARC type 3 bleeding, repeat revascularization and 5-year time-averaged SAQ-7 QoL score. [Срок оценки: 5 years]

Критерии участия

Критерии включения

• Age ≥18 years
• Elective first-time CABG with use of ≥1 saphenous vein graft;
• Ability to sign informed consent and comply with all study procedures, including follow-up for at least 5 years.

Критерии исключения

• Any indication for dual antiplatelet therapy, including

• Acute/recent (within 1 year) ACS (NSTE-ACS or STEMI)
• Recent PCI requiring continuation of dual antiplatelet therapy after CABG
• Current or anticipated use of oral anticoagulation;
• Paroxysmal, persistent or permanent atrial fibrillation;
• Any concomitant cardiac or non-cardiac procedure;
• Planned cardiac or non-cardiac surgery within one year;
• Preoperative end-organ dysfunction (dialysis, moderate to severe liver failure, respiratory failure), cancer or other non-cardiac comorbidity with a life expectancy <5 years;
• Inability to use the saphenous vein;
• Contraindications to the use of aspirin;
• Contraindications to the use of ticagrelor, including

• Known hypersensitivity to ticagrelor
• Active pathological bleeding (including, but not limited to gastrointestinal or intracranial bleeding)
• History of intracranial hemorrhage
• Concomitant therapy with strong CYP3A4 inhibitors (eg ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir)
• Inability to undergo coronary computed tomographic angiography (CCTA);
• Participating in another investigational device or drug study;
• Women of childbearing potential
• Any major perioperative complication including, but not limited to, stroke, TIA, MI, CABG-related bleeding (BARC type 4), sepsis.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Германия · 7 центров

• University Hospital of Düsseldorf — Düsseldorf
• Westdeutsches Herz- und Gefäßzentrum Essen, Universität Duisburg-Essen — Essen
• Klinik für Herz- und Gefäßchirurgie - Universitäts-Herzzentrum Freiburg - Bad Krozingen — Freiburg im Breisgau
• University Hospital Giessen — Giessen
• Jena University Hospital — Jena
• LMU Klinikum Campus Großhadern — München
• Robert-Bosch-Krankenhaus Stuttgart — Stuttgart

Австрия · 4 центра

• Medical University Innsbruck — Innsbruck
• Medical University Graz — Graz
• Johannes Kepler University Linz — Linz
• Medical University of Vienna — Vienna

Китай · 4 центра

• Ruijin Hospital: Shanghai Jiao Tong University School of Medicine — Шанхай
• Jilin Heart Hospital — Changchun
• Beijing Anzhen Hospital — Пекин
• Center China Fuwai Hospital — Пекин

США · 3 центра

• Englewood Hospital — Englewood
• NewYork-Presbyterian: Queens Hospital — Flushing
• Weill Cornell Medicine — New York

Швеция · 3 центра

• Sahlgrenska University Hospital — Gothenburg
• Sahlgrenska University Hospital Sweden — Gothenburg
• Skåne University Hospital — Malmö

Канада · 1 центр

• University of Ottawa Heart Institute — Ottawa

Публикации

• 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. PMID 35943473
• 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 PMID 38436365

Идентификаторы

NCT: NCT05997693 · 23-06026202 · 2023-506613-22 · 488058

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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