Efficacy and Safety of Aspirin in Patients With Chronic Coronary Syndromes Without Revascularization

Обзор

The purpose of this study is to evaluate the efficacy and safety aspirin in patients with chronic coronary syndromes without revascularization.

Подробное описание

Aspirin for secondary prevention in the acute phase of acute coronary syndromes has been established. Although it is still disputable about the duration, there is also a consensus for antiplatelet therapy in patients after percutaneous coronary revascularization. On the other hand, several large randomized clinical trials (RCTs) have shown that aspirin treatment for primary prevention of cardiovascular events increases bleeding events and does not provide net clinical benefit.Patient with chronic coronary syndromes (CCS) but not eligible for revascularization do not belong to any of these categories and there is no evidence on the efficacy of aspirin in this population. Therefore, we designed a multicenter, randomized, open-label study to evaluate the efficacy and safety of aspirin in patients with CCS who are not eligible for revascularization.

Вмешательства

• Препарат Aspirin
  Aspirin 100 mg/day
• Препарат No aspirin
  No aspirin administered

Первичные конечные точки

• Composite cardiovascular events [Срок оценки: 5 years]

Вторичные конечные точки (12)

• All-cause death [Срок оценки: 5 years]
• Myocardial infarction [Срок оценки: 5 years]
• Ischemic stroke [Срок оценки: 5 years]
• Coronary revascularization [Срок оценки: 5 years]
• Peripheral revascularization [Срок оценки: 5 years]
• Critical limb ischemia [Срок оценки: 5 years]
• Cardiovascular death [Срок оценки: 5 years]
• Major bleeding [Срок оценки: 5 years]
• Hospital admission for heart failure [Срок оценки: 5 years]
• Cancer incidence [Срок оценки: 5 years]
• Cancer death [Срок оценки: 5 years]
• Composite of all-cause mortality, myocardial infarction, ischemic stroke, coronary revascularization, lower extremity revascularization, critical lower extremity ischemia, major bleeding, hospital admission for heart failure, cancer death [Срок оценки: 5 years]

Критерии участия

Критерии включения

• Patients with chronic coronary syndromes with ≧50% diameter stenosis in one or more major coronary vessels/major branches on coronary CT or coronary angiography but not eligible for coronary revascularization
• Patients for whom consent can be obtained

Критерии исключения

• Patients with history of acute coronary syndromes (ACS)
• Patients with history of percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
• Patients with left main trunk stenosis (≥50%)
• Patients for whom aspirin administration is mandatory
• Patients undergoing antithrombotic therapy other than aspirin
• Patients with atrial fibrillation
• Patients with history of stroke within six months
• Patients scheduled for major surgical procedures that will require aspirin discontinuation
• Patients with contraindication of aspirin
• Patients expected to have a prognosis of 1 year or less due to comorbidities
• Women of child-bearing potential or women who have a positive pregnancy test at enrolment or randomization
• Patients who are judged by attending physicians to be inappropriate to participate in this study

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

Япония · 1 центр

• Kyoto University Hospital — Kyoto

Идентификаторы

NCT: NCT05347069 · Y0126

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗