About this trial
The purpose of this study is to evaluate the efficacy and safety aspirin in patients with chronic coronary syndromes without revascularization.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Aspirin
DrugAspirin 100 mg/day
No aspirin
DrugNo aspirin administered
Treatment groups
Trial outcomes
Primary outcomes
Composite cardiovascular events
Composite of all-cause death, myocardial infarction, ischemic stroke, coronary revascularization, peripheral revascularization, or critical limb ischemia
Secondary outcomes
All-cause death
As classified by Academic Research Consortium (ARC) (Circulation. 2007;115:2344-2351). 1. Cardiac Death: Any death due to proximate cardiac cause, unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease should be classified as cardiac. 2. Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. 3. Non-cardiovascular Death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. 4. Cancer related death: death from cancer cause
Myocardial infarction
As classified by Academic Research Consortium (ARC): However, the sensitivity is too high for the evaluation with Troponin of the peri-procedural MI, thus CKMB will be used.
Ischemic stroke
Ischemic stroke is defined as acute onset of a neurological deficit that persists for at least 24 hours and is the result of a disturbance of the cerebral circulation due to ischemia. Deficits that last ≤ 24 hours are due to transient ischemic neurological attack and are not classified in this category.
Coronary revascularization
The revascularization that meets the following criteria is considered as clinically indicated revascularization. Presence/absence of clinical findings is judged by the operator of the procedure before the revascularization.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Takeshi Morimoto
Lead sponsor
Kyoto University, Graduate School of Medicine
Sponsor institution