Aspirin for patients with chronic coronary syndromes without revascularization

JRCT ID: jRCT1051220039

Registered date:09/06/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: chronic coronary syndromes
• Date of first enrollment: 14/06/2022
• Target sample size: 2890
• Study type: Interventional

Intervention(s)

1) Aspirin group
2) Aspirin-free group

Outcome(s)

• Primary Outcome: Composite of all-cause death, myocardial infarction, ischemic stroke, clinically indicated coronary revascularization, clinically indicated peripheral revascularization, critical limb ischemia
• Secondary Outcome: Each of the primary endpoints, cardiovascular death, major bleeding (BARC 3 or 5), hospital admission for heart failure, the incidence of cancer, cancer death, composite of all-cause death, myocardial infarction, ischemic stroke, clinically indicated coronary revascularization, clinically indicated peripheral revascularization, critical limb ischemia, major bleeding, hospital admission for heart failure, cancer death

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients with chronic coronary syndromes who have more than 50 percent diameter stenosis in one or more major coronary vessels/major branches, but are not eligible for revascularization

Exclude criteria

History of ACS
History of PCI or CABG
Patients with left main trunk stenosis
Patients for whom aspirin administration is mandatory
Patients undergoing antithrombotic therapy other than aspirin
History of stroke within 6 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 enrollment or randomization
Patients who are not appropriate for the participation in the study

Related Information

• Primary Sponsor: Yamamoto Erika
• Source(s) of Monetary Support: DAIICHI SANKYO HEALTHCARE,Mitsubishi Tanabe Pharma Corporation
• Secondary ID(s): NCT05347069