Comparing High and lOw-dose asPirin With Dual anTIplatelet Therapy for Three Months Using prasUgrel and aSpirin Following Coronary Artery Bypass Grafting. (OPTIMUS-CABG Trial)

Обзор

The purpose of this study is to compare the effect of prasugrel plus low-dose aspirin versus high dose aspirin alone (300mg) and versus low dose aspirin alone (75 mg) in patients with chronic coronary disease undergoing coronary artery bypass grafting.

Подробное описание

This is a multicenter, randomized trial evaluating the effect of low-dose aspirin plus prasugrel versus low-dose ASA and versus high-dose ASA for three months, followed by low-dose ASA alone, on graft failure at 12 months in patients with stable coronary artery disease (chronic coronary syndrome) following a coronary artery bypass grafting.

Вмешательства

• Препарат High-Dose Aspirin 300 mg
  High-dose Aspirin 300 mg once daily taken orally for three months
• Препарат DAPT (Low-Dose Aspirin 75 mg + Prasugrel 10 mg)
  Drug: Prasugrel 10 mg Prasugrel 10 mg once daily taken orally for 3 months Drug: Low-Dose Aspirin 75 mg once daily taken orally
• Препарат Low-Dose Aspirin 75 mg
  Low-Dose Aspirin 75 mg once daily taken orally

Первичные конечные точки

• Incidence of graft failure: DAPT vs Low-Dose Aspirin and DAPT vs High-Dose Aspirin [Срок оценки: 12 months]

Вторичные конечные точки (5)

• Key secondary outcome: Incidence of graft failure: High-Dose Aspirin vs Low-Dose Aspirin [Срок оценки: 12 months]
• investigatigating the effect of DAPT versus low-dose aspirin, DAPT versus high-dose aspirin and low-dose aspirin versus high-dose aspirin on the 12-month risk of ischemic events after CABG [Срок оценки: 12 months]
• Investigatigating the effect of DAPT versus low-dose aspirin, DAPT versus high-dose aspirin and low-dose aspirin versus high-dose aspirin on the 12-month risk of bleeding events after CABG [Срок оценки: 12 months]
• Investigatigating the effect of DAPT versus low-dose aspirin, DAPT versus high-dose aspirin and low-dose aspirin versus high-dose aspirin on quality of life at 6 and 12 months after CABG. [Срок оценки: 12 months]
• investigatigating the effect of DAPT versus low-dose aspirin, DAPT versus high-dose aspirin and low-dose aspirin versus high-dose aspirin on the 60-month risk of ischemic events after CABG [Срок оценки: 60 months]

Критерии участия

Критерии включения

A. Baseline (preoperative) inclusion criteria

• Age >18 years
• Primary isolated CABG patients with stable coronary artery disease (chronic coronary syndrome) planned for at least 2 grafts. Coronary artery disease will be defined as a stenosis ≥ 70% based on coronary angiography, a FFR value ≤ 0.80 or iFr value ≤0.89; a left main diameter stenosis ≥ 50%, left main IVUS MLA value ≤ 6 mm2, or equivalent OCT measurements will also be considered.
• Ability to comply with all study procedures and follow-up procedures
• Signed Informed Consent to participate in the study.

B. Operative inclusion criteria:

• Intraoperative graft evaluation using transit time flow measurement in all grafts, normal flow in any graft is defined as mean graft flow > 15 mL/min with Pulsatility Index < 5
• Left anterior descending artery grafted with internal thoracic artery
• No intraoperative decision for hybrid revascularization due to incomplete revascularization (Percutaneous coronary intervention (PCI) of the ungrafted vessel)
• No endarterectomy of the grafted vessel performed
• Patient did not have any additional unplanned procedure (Ex. LAAC, Ablation, valve intervention, aortic intervention)

Критерии исключения

A. Baseline (preoperative) exclusion criteria:

• Cardiogenic shock
• Patients with recent acute coronary syndrome (ACS) (<12 months)
• Single vessel CABG
• Patients with preoperative atrial fibrillation
• Dialysis
• Thrombocytopenia (platelet count < 100 000 platelets/uL)
• Anemia (Hemoglobin level < 10 g/dL)
• Severe liver failure Child-Pugh classification >4
• Known, active infections with HIV, HBV, HCV, tuberculosis
• Active malignant disease or history of malignancy within the past 5 years
• Indication for DAPT (e.g. recent PCI or ACS or recent stents of peripheral arteries)
• Indication for oral anticoagulant treatment 13 Indications for the use of methotrexate at a dose of 15 mg/week or more

14\. Any contraindication for prasugrel or ASA 15. Planned additional cardiac or non-cardiac surgery within 12 months 16. Non-cardiac co-morbidity with life expectancy less than 12 months 17. History of any bleeding complications due to the use of DAPT 18. History of intracranial bleeding 19. History of gastro-intestinal bleeding 20. Pregnancy or breastfeeding 21. Lack of compliance with the use of a highly effective method of birth control 22. Planned coronary endarterectomy 23. Severe impaired renal function (eGFR <40mL/min/1.73 m2).

B. Postoperative and prior randomization exclusion criteria:

• Perioperative cardiogenic shock
• Intraoperative death or death prior randomization
• Myocardial infarction within 12-24 hours following CABG or prior randomization
• Ischemic or hemorrhagic stroke within 12-24 hours following CABG or prior randomization
• Any postoperative complication that may increase patients' risk with DAPT
• Atrial Fibrillation prior randomization
• Gastro-intestinal bleeding prior randomization

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

Польша · 18 центров

• University Clinical Hospital in Bialystok — Bialystok
• Nicolaus Copernicus University Ludwik Rydygier Collegium Medicum in Bydgoszcz — Bydgoszcz
• Medical University of Gdansk — Gdansk
• Regional Specialist Hospital in Grudziadz — Grudziądz
• Upper-Silesian Heart Center — Katowice
• John Paul II Hospital — Krakow
• Medical University of Lodz — Lodz
• Zbigniew Religa Heart Center "Medinet" — Nowa Sól
• … и ещё 10 центров

Идентификаторы

NCT: NCT07195149 · 2024/ABM/01/00016 · 2025-521892-30-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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