Efficacy and Safety of Aspirin in Patients with Chronic Coronary Syndromes Without Revascularization (ASA-IN)

Takeshi Morimoto

Status and phase: Enrolling; Phase 4

Conditions: Ischemic Heart Disease; Coronary Artery Disease; Stable Angina Pectoris

Treatments: Drug: No aspirin; Drug: Aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT05347069

Y0126

Details and patient eligibility

About

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

Full description

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.

Enrollment: 2,890 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,890 participants in 2 patient groups

Aspirin

Active Comparator group

Description:

Aspirin 100 mg/day

Treatment:

Drug: Aspirin

No Aspirin

Active Comparator group

Description:

No Aspirin

Treatment:

Drug: No aspirin