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

Study acronym: DAN-RELEASE
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Recruitment opened
    • Start date changed from estimate of Sep 14, 2026 to Sep 30, 2026
    • Study sites: 1 to 2
  2. Secondary endpoints: details revised at 4 of 13 entries
    • Study description shortened, about 270 words
    • Eligibility criteria expanded, about 2 words
    • Study title shortened, about 4 words
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07795398
Lead Sponsor Odense University Hospital
Collaborators: University Hospital Bispebjerg and Frederiksberg
Conditions
(from sponsor)		 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 +1 more
Related terms Myocardial Infarction, Myocardial Ischemia
Enrollment 7,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov