Phase 4Recruiting
DAN-RELEASE - Reconsidering Long-Term Aspirin in the Elderly Patients With Stable Ischemic Heart Disease
The RELEASE Trial: Reconsidering Long-Term Aspirin in the Elderly in Secondary Prevention of Cardiovascular Disease
- Sponsor
- Odense University Hospital (Academic or other)
- Enrolment
- 7,000 planned
- Conditions
- Ischemic Heart Disease; Ischemic Heart Disease Chronic; Chronic Coronary Syndrome; Myocardial Infarction; Percutaneous Coronary Intervention; Coronary Artery Bypass Graft; Aspirin; Aspirin Causing Adverse Effects in Therapeutic Use; Non-inferiority Trial
- Interventions
- Continuation of daily low-dose Aspirin; Discontinuation of daily low-dose Aspirin
- Ages
- older adults
- Registry
- NCT07795398
From the registry
DAN-RELEASE is a national, randomized, registry-based trial including 7,000 participants in Denmark. The trial aims to determine whether discontinuation of long-term aspirin therapy is non-inferior to continued aspirin therapy in older adults with stable ischemic heart disease. Long-term aspirin therapy is recommended for patients with established ischemic heart disease. However, among clinically stable patients years after percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), or myocardial infarction (MI), the evidence supporting lifelong aspirin therapy is limited. At the same time, the risk of serious bleeding increases with age. DAN-RELEASE will therefore compare aspirin discontinuation with continued aspirin therapy in adults aged 65 years or older with stable ischemic heart disease who have remained free from ischemic events for at least two years. The trial will assess whether discontinuing aspirin is non-inferior to continued treatment with respect to cardiovascular and bleeding outcomes.
Primary outcomes
- Hierarchical Composite of Cardiovascular and Bleeding Events