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临床试验/NCT07195149
NCT07195149招募中3 期

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)

Dolnośląskie Centrum Chorób Serca im.prof. Zbigniewa Religi MEDINET Sp. z o.o.36 个研究点 分布在 1 个国家目标入组 1,703 人开始时间: 2025年11月25日最近更新:
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干预措施

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
1,703
试验地点
36
主要终点
Incidence of graft failure: DAPT vs Low-Dose Aspirin and DAPT vs High-Dose Aspirin
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •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)

排除标准

  • •A. Baseline (preoperative) exclusion criteria:
  • •Cardiogenic shock
  • •Patients with recent acute coronary syndrome (ACS) (<12 months)
  • •Single vessel CABG
  • •Patients with preoperative atrial fibrillation
  • •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
  • •Planned additional cardiac or non-cardiac surgery within 12 months
  • •Non-cardiac co-morbidity with life expectancy less than 12 months
  • •History of any bleeding complications due to the use of DAPT
  • •History of intracranial bleeding
  • •History of gastro-intestinal bleeding
  • •Pregnancy or breastfeeding
  • •Lack of compliance with the use of a highly effective method of birth control
  • •Planned coronary endarterectomy
  • •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

研究组 & 干预措施

Low-Dose Aspirin 75 mg

Active Comparator

干预措施: Low-Dose Aspirin 75 mg (Drug)

High-Dose Aspirin 300 mg

Active Comparator

干预措施: High-Dose Aspirin 300 mg (Drug)

Prasugrel 10 mg + Low Dose Aspirin 75 mg

Experimental

干预措施: DAPT (Low-Dose Aspirin 75 mg + Prasugrel 10 mg) (Drug)

结局指标

主要结局

Incidence of graft failure: DAPT vs Low-Dose Aspirin and DAPT vs High-Dose Aspirin

时间窗: 12 months

Incidence of graft failure defined according to Fitzgibbon classification (Fitzgibbon Class B + O) 12 months after the randomization following CABG in patients with DAPT (prasugrel 10mg/day + low dose aspirin 75mg/day) versus high-dose aspirin (300mg/day) and in patients with DAPT (prasugrel 10mg/day + low dose aspirin 75mg/day) vs low-dose aspirin (75mg/day)

次要结局

  • Key secondary outcome: Incidence of graft failure: High-Dose Aspirin vs Low-Dose Aspirin(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(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(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.(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(60 months)

研究者

发起方
Dolnośląskie Centrum Chorób Serca im.prof. Zbigniewa Religi MEDINET Sp. z o.o.
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sleiman Sebastian Aboul-Hassan

Principal Investigator: Sleiman Sebastian Aboul-Hassan MD, PhD

Dolnośląskie Centrum Chorób Serca im.prof. Zbigniewa Religi MEDINET Sp. z o.o.

研究点 (36)

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