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

RecruitingPhase 4Ages 65 Years - anyAllOdense University Hospital
NCT07795398 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Continuation of daily low-dose Aspirin
  • Discontinuation of daily low-dose Aspirin
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Where

2 sites
Bispebjerg Frederiksberg Hospital
Copenhagen, Denmark
Odense Universitetshospital
Odense, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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