NCT07854795Not yet recruitingPhase 4
Reconsidering Long-Term Apirin in the Elderly in Secondary Prevention of Coronary Artery Disease Norway
REconsidering Long-TErm ASpirin in the Elderly in Secondary Prevention of Coronary Artery Disease (RELEASE) Norway: A Randomised, Registry-based Trial
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 7000 (estimated)
- First submitted
- 22 Sept 2026
- Start date
- 1 Feb 2027
- Primary completion date
- 1 Dec 2030
- Lead sponsor
- Vestre Viken Hospital Trust
- Diseases
- Coronary artery disease
- NCT number
- NCT07854795
- EU CT number
- 2026-526941-91-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 7000
- From 1 Feb 2027 to the primary completion date, 1 Dec 2030
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active treatment with or indication for anti-coagulant or P2Y12-inhibitor therapy
Other illness
- 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
Age
- 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.
Who the study is looking for
- 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
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sørlandet Hospital Trust Arendal Coordinator of this site? Confirm its status | Arendal | Norway | Unknown status |
| Haukeland University Hospital Coordinator of this site? Confirm its status | Bergen | Norway | Unknown status |
| Drammen hospital Coordinator of this site? Confirm its status | Drammen | Norway | Unknown status |
| Akershus University Hospital Coordinator of this site? Confirm its status | Lørenskog | Norway | Unknown status |
| Oslo University Hospital, Rikshospitalet Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
| Oslo University Hospital Ullevaal Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
| Stavanger Universty Hospital Coordinator of this site? Confirm its status | Stavanger | Norway | Unknown status |
| University Hospital of North Norway, Tromsø Coordinator of this site? Confirm its status | Tromsø | Norway | Unknown status |
| St Olavs Hospital Coordinator of this site? Confirm its status | Trondheim | Norway | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.