RELEASE - Reconsidering Long-Term Aspirin in the Elderly Patients With Stable Ischemic Heart Disease: A Randomized Non-Inferiority Trial

Sponsor
Odense University Hospital
Study ID
NCT07795398
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Aspirin
  • Aspirin Causing Adverse Effects in Therapeutic Use
  • Chronic Coronary Syndrome
  • Coronary Artery Bypass Graft
  • Ischemic Heart Disease
  • Ischemic Heart Disease Chronic
  • Myocardial Infarction
  • Non-inferiority Trial
  • Percutaneous Coronary Intervention

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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. 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.

Key Dates

First listed
Aug 31, 2026
Start date
Sep 14, 2026
Status verified
Aug 2026
Primary completion
Oct 31, 2029
Completion
Oct 31, 2029

Study Design

Enrollment
7,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Continuation of Aspirin
    Participants randomized to this arm will continue their current long-term low-dose aspirin therapy.
  • Active Comparator: Discontinuation of Aspirin
    Participants randomized to this arm will discontinue their current long-term low-dose aspirin therapy.

Primary Outcome Measure

Hierarchical Composite of Cardiovascular and Bleeding Events [ Time Frame: From randomization until the end of the study, with a minimum follow-up of 1 year ]

Central Contacts

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