NCT07795398RecruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 7000 (estimated)
- First submitted
- 26 Aug 2026
- Start date
- 30 Sept 2026
- Primary completion date
- 31 Oct 2029
- Lead sponsor
- Odense University Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT07795398
- EU CT number
- 2026-525442-30-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 7000
- From 30 Sept 2026 to the primary completion date, 31 Oct 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active treatment with or indication for anti-coagulant or P2Y12-inhibitor therapy
Other illness
- 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
- Other contraindications to aspirin discontinuation according to treating physician
- Not being able to understand Danish
Who the study is looking for
- 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)
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Copenhagen University Hospital Coordinator of this site? Confirm its status | Copenhagen Nv | Denmark | Recruiting |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.