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

NCT07795398 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 7000

Last updated 2026-08-31

No results posted yet for this study

Summary

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.

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

Interventions

DRUG

Continuation of daily low-dose Aspirin

Participants randomized to this intervention will continue their current daily low-dose aspirin therapy.

DRUG

Discontinuation of daily low-dose Aspirin

Participants randomized to this intervention will discontinue their current daily low-dose aspirin therapy.

Sponsors & Collaborators

  • University Hospital Bispebjerg and Frederiksberg

    collaborator OTHER

  • Odense University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-14
Primary Completion
2029-10-31
Completion
2029-10-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07795398 on ClinicalTrials.gov