NCT05347069

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,890 (estimated)
• Sponsor: Takeshi Morimoto · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Stable Angina Pectoris
• Coronary Artery Disease
• Ischemic Heart Disease

Interventions

Type	Name	Description
DRUG	Aspirin	Aspirin 100 mg/day
DRUG	No aspirin	No aspirin administered

Timeline

• Start date: 2022-06-14
• Primary completion: 2030-03-01
• Completion: 2030-12-01
• First posted: 2022-04-26
• Last updated: 2025-03-11

Locations

1 site across 1 country: Japan