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DAN-RELEASE - Reconsidering Long-Term Aspirin in the Elderly Patients With Stable Ischemic Heart Disease

Sponsor: Odense University Hospital • ClinicalTrials.gov ID: NCT07795398

Registry updated: 2026-10-05

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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. 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.

Interventions

Continuation of daily low-dose Aspirin (Drug)
Participants randomized to this intervention will continue their current daily low-dose aspirin therapy.
Discontinuation of daily low-dose Aspirin (Drug)
Participants randomized to this intervention will discontinue their current daily low-dose aspirin therapy.

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

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

Locations

Bispebjerg Frederiksberg Hospital — Copenhagen, Denmark
Odense Universitetshospital — Odense, Denmark

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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