NCT07795398 DAN-RELEASE - Reconsidering Long-Term Aspirin in the Elderly Patients With Stable Ischemic Heart Disease
| NCT ID | NCT07795398 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Odense University Hospital |
| Condition | Ischemic Heart Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 7,000 participants |
| Start Date | 2026-09-30 |
| Primary Completion | 2029-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 7,000 participants in total. It began in 2026-09-30 with a primary completion date of 2029-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * History of ischemic stroke * Active treatment with or indication for anti-coagulant or P2Y12-inhibitor therapy * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07795398 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Ischemic Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07795398 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07795398 currently recruiting?
Yes, NCT07795398 is actively recruiting participants. Contact the research team at Axel.Diederichsen@rsyd.dk for enrollment information.
Where is the NCT07795398 trial being conducted?
This trial is being conducted at Copenhagen, Denmark, Odense, Denmark.
Who is sponsoring the NCT07795398 clinical trial?
NCT07795398 is sponsored by Odense University Hospital. The trial plans to enroll 7,000 participants.