The purpose of this study is to evaluate the efficacy and safety aspirin in patients with chronic coronary syndromes without revascularization.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
2,890
Aspirin 100 mg/day
No aspirin administered
Kyoto University Hospital
Kyoto, Japan
RECRUITINGComposite cardiovascular events
Composite of all-cause death, myocardial infarction, ischemic stroke, coronary revascularization, peripheral revascularization, or critical limb ischemia
Time frame: 5 years
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
Time frame: 5 years
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.
Time frame: 5 years
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.
Time frame: 5 years
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.
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Time frame: 5 years
Peripheral 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.
Time frame: 5 years
Critical limb ischemia
Critical limb ischemia is defined by chronic ischemic pain at rest and/or presence of ischemic skin lesions (gangrene or ulcerations).
Time frame: 5 years
Cardiovascular death
1. Cardiac Death: Any death due to proximate cardiac cause (e.g. myocardial infarction \[MI\], low-output failure, fatal arrhythmia), 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 (e.g. cancer, infection) 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.
Time frame: 5 years
Major bleeding
Bleeding/Hemorrhagic Complications will be evaluated using the Bleeding Academic Research Consortium (BARC) definition. Major bleeding is defined as BARC 3 or 5.
Time frame: 5 years
Hospital admission for heart failure
An unplanned hospitalization with heart failure. Heart failure is defined by the modified Framingham criteria as follow: \[Major Criteria\] 1) Paroxysmal nocturnal dyspnea 2) Orthopnea 3) Neck-vein distension 4) Rales 5) Acute pulmonary edema \[Minor Criteria\] 1. Ankle edema 2. Dyspnea on exertion 3. Pleural effusion 4. Tachycardia (HR ≧ 120/min) \* For establishing a definite diagnosis of heart failure, 2 Major criteria or 1 major and 2 minor criteria must be present concurrently
Time frame: 5 years
Cancer incidence
1. Non-metastatic cancer (not present prior to randomization) 2. Metastatic cancer (cancer that was metastatic at presentation, metastasis of a non-metastatic cancer presents at baseline, or blood cancer) Non-melanoma skin cancer was excluded cancer end points.
Time frame: 5 years
Cancer death
Cancer death is defined as death from cancer cause.
Time frame: 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
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
Time frame: 5 years