Stopping long-term aspirin in older people with stable coronary artery disease
Tests whether older people with coronary artery disease can safely stop aspirin.
Plain-language title generated from the registry record
Registry title: Reconsidering Long-Term Apirin in the Elderly in Secondary Prevention of Coronary Artery Disease Norway
Key facts
- Where
- Arendal, Bergen, Drammen, Lørenskog, Oslo, Stavanger, Tromsø, and Trondheim, NorwaySee the 9 sites
- Phase
- Phase 4
Where in Norway
- Sørlandet Hospital Trust ArendalArendal, NorwayNo longer taking part
- Haukeland University HospitalBergen, NorwayNo longer taking part
- Drammen hospitalDrammen, NorwayNo longer taking part
- Akershus University HospitalLørenskog, NorwayNo longer taking part
- Oslo University Hospital UllevaalOslo, NorwayNo longer taking part
- Oslo University Hospital, RikshospitaletOslo, NorwayNo longer taking part
- Stavanger Universty HospitalStavanger, NorwayNo longer taking part
- University Hospital of North Norway, TromsøTromsø, NorwayNo longer taking part
- St Olavs HospitalTrondheim, NorwayNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Vestre Viken Hospital Trust
- Trial code
- NCT07854795EU 2026-526941-91-00
- Record updated
- 9 November 2026
- Original description
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 inform future guidelines and clinical practice worldwide. Imaging and PROMS sub-studies will explore clinical and psychosocial mechanisms, providing insight into treatment heterogeneity and enabling future personalised antiplatelet therapy. Additionally, a health-economic analysis will assess the cost-effectiveness of discontinuing aspirin for healthcare systems.Read full original descriptionShow less
REconsidering Long-TErm ASpirin in the Elderly in Secondary Prevention of Coronary Artery Disease (RELEASE) Norway: A Randomised, Registry-based Trial
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 inform future guidelines and clinical practice worldwide. Imaging and PROMS sub-studies will explore clinical and psychosocial mechanisms, providing insight into treatment heterogeneity and enabling future personalised antiplatelet therapy. Additionally, a health-economic analysis will assess the cost-effectiveness of discontinuing aspirin for healthcare systems.
Inclusion: Age ≥65 years at randomization treated with low-dose (≤150 mg/day) aspirin; An ACS event treated with PCI 2-8 years prior to randomisation and no ischemic cardiovascular event (MI or stroke) or any coronary revascularization procedure (PCI/coronary artery bypass grafting) since index event; Signed informed consent and expected cooperation according to ICH/GCP and national/local regulations.
Exclusion: Active treatment with or indication for anti-coagulant or P2Y12-inhibitor therapy; Indication for antiplatelet treatment other than secondary prevention of CAD (i.e. haematological diseases, stroke, PAD); Left main stenosis or any history of stent thrombosis, or other contraindications to discontinuation of aspirin according to treating physician; Life expectancy <12 months due to non-cardiac reasons or not being able to understand Norwegian or English language; Any condition (e.g. drug/alcohol abuse, dementia) or situation, that in the investigator's opinion could put the subject at signifi-cant risk directly related to the randomized aspirin strategy, confound the results, interfere significantly with participation, or render informed consent unfeasible. Investigators are explicitly encouraged not to exclude patients solely due to advanced age, frailty or polypharmacy if equipoise exists regarding aspirin continuation vs. discontinuation and informed consent is feasible.