Stopping or continuing daily low-dose aspirin in older adults with stable heart disease
Compares stopping with continuing daily aspirin in older adults with stable heart disease.
Plain-language title generated from the registry record
Registry title: DAN-RELEASE - Reconsidering Long-Term Aspirin in the Elderly Patients With Stable Ischemic Heart Disease
Key facts
- Where
- Copenhagen Nv and Odense, DenmarkSee the 2 sites
- Phase
- Phase 4
Where in Denmark
- Copenhagen University HospitalCopenhagen Nv, DenmarkTaking people
- Odense University HospitalOdense, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Odense University Hospital
- Trial code
- NCT07795398EU 2026-525442-30-00
- Record updated
- 5 October 2026
- Original description
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.Read full original descriptionShow less
The RELEASE Trial: Reconsidering Long-Term Aspirin in the Elderly in Secondary Prevention of Cardiovascular Disease
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.
Inclusion: Age ≥65 years at randomization; Ischemic heart disease (IHD) with index event (myocardial infarction (MI), percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG)) >2 years previously; Since index event free from ischemic cardiovascular events (MI, ischemic stroke, or transitory ischemic attack) or any coronary revascularization procedure (PCI/CABG); Currently treated with low dose aspirin (≤150 mg daily).
Exclusion: Active treatment with or indication for anti-coagulant or P2Y12-inhibitor therapy; History of ischemic stroke; Indication for antiplatelet treatment other than secondary prevention of IHD according to treating physician (i.e. haematological diseases, peripheral artery disease); Any revascularization procedure for peripheral artery disease; Any history of stent thrombosis or stenting of the left main coronary artery; Other contraindications to aspirin discontinuation according to treating physician; Not being able to understand Danish.