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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age20+
SponsorTakeshi Morimoto

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Aspirin

    Drug

    Aspirin 100 mg/day

  • No aspirin

    Drug

    No aspirin administered

Treatment groups

2,890 Participants
are divided into 2 treatment groups
Group A: AspirinActive comparator 1 intervention
Group B: No AspirinActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Composite cardiovascular events

Composite of all-cause death, myocardial infarction, ischemic stroke, coronary revascularization, peripheral revascularization, or critical limb ischemia

Time frame
5 years

Secondary outcomes

1

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
2

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
3

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
4

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.

Time frame
5 years

Other outcomes

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