Phase 4Not yet recruiting
Reconsidering Long-Term Apirin in the Elderly in Secondary Prevention of Coronary Artery Disease Norway (RELEASE-Norway)
REconsidering Long-TErm ASpirin in the Elderly in Secondary Prevention of Coronary Artery Disease (RELEASE) Norway: A Randomised, Registry-based Trial
- Sponsor
- Vestre Viken Hospital Trust (Academic or other)
- Enrolment
- 7,000 planned
- Conditions
- Coronary Arterial Disease (CAD)
- Interventions
- Discontinuation of aspirin (ATC-code B01AC06 and N02BA01)
- Ages
- older adults
- Registry
- NCT07854795
Full record on ClinicalTrials.gov
From the registry
Lifelong aspirin has been a cornerstone of secondary prevention after coronary artery disease (CAD), based on trials conducted 40-50 years ago. Since then, major advances in coronary reperfusion and risk factor management have significantly improved outcomes. At the same time, aspirin is clearly associated with an increased risk of major bleeding, including intracranial haemorrhage. This raises a critical, yet unanswered question: in patients more than 2 years after a CAD event, does the benefit of continued aspirin still outweigh its bleeding risk? RELEASE-Norway is an investigator-initiated, registry-based, randomised trial with blinded endpoint assessment (PROBE design) designed to determine whether patients with chronic CAD can safely stop aspirin without losing cardiovascular protection. The trial will randomise 7,000 patients from all major hospitals in Norway. Together with a similar trial (RELEASE-Denmark, n≈7,000) planned in Denmark, the study will provide definitive evidence on the long-term net clinical benefit versus harm of aspirin in stable CAD and most likely directly…
Primary outcomes
- Hierarchical composite endpont
History
Study completion expected
Primary completion expected
Expected to start
Registered