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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

2890 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-14

Study Completion Date

2030-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Stable Angina Pectoris Coronary Artery Disease Ischemic Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Aspirin

Aspirin 100 mg/day

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

Aspirin 100 mg/day

No Aspirin

Group Type ACTIVE_COMPARATOR

No aspirin

Intervention Type DRUG

No aspirin administered

Interventions

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Aspirin

Aspirin 100 mg/day

Intervention Type DRUG

No aspirin

No aspirin administered

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No