2026-526941-91-00RecruitingPhase 4
REconsidering Long-TErm ASpirin in the Elderly in Secondary Prevention of Coronary Artery Disease (RELEASE) Norway: A Randomised, Registry-based Trial
Vestre Viken HF9 sites in 1 countryEnrollment: 7,000Started: January 4, 2027Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 7,000
- Locations
- 9
- Primary Endpoint
- Hierarchical composite of 1. cardio-vascular death, 2. number of re-hospitalizations for non-fatal intra-cranial bleeding, 3, non-fatal myo-cardial infarctions including stent thrombosis, 4. non-fatal ischemic stroke, and 5. major bleeding (BARC 3-5) requir-ing hospitalization.
Study Overview
Brief Summary
To compare the net clinical benefit of discontinuing versus continuing aspirin in patients randomized 2–8 years after an index ACS event, using a hierarchical composite endpoint that includes cardiovascular death, intracranial bleeding, myocardial infarction including stent thrombosis, ischaemic stroke, and major bleeding (BARC 3–5) requiring hospitalisation.
Study Design
- Allocation
- Randomized
- Primary Purpose
- Follow-up period
- Masking
- None (open label)
Eligibility Criteria
- Ages
- 65 years to 65+ years (65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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 Criteria
- Indication for antiplatelet treatment other than secondary prevention of CAD (i.e. haematological diseases, stroke, PAD)
- Active treatment with or indication for anti-coagulant or P2Y12-inhibitor therapy
- Left main stenosis or any history of stent thrombosis, or other contraindications contraindications to the discontinuation of aspirin according to treating physician
- 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.
- Life expectancy <12 months) due to non-cardiac reasons or not being able to understand Norwegian or English language
Arms & Interventions
Albyl-E 75 mg enterotabletter
Test
Intervention: Albyl-E 75 mg enterotabletter (Drug)
Outcomes
Primary Outcomes
Hierarchical composite of 1. cardio-vascular death, 2. number of re-hospitalizations for non-fatal intra-cranial bleeding, 3, non-fatal myo-cardial infarctions including stent thrombosis, 4. non-fatal ischemic stroke, and 5. major bleeding (BARC 3-5) requir-ing hospitalization.
Hierarchical composite of 1. cardio-vascular death, 2. number of re-hospitalizations for non-fatal intra-cranial bleeding, 3, non-fatal myo-cardial infarctions including stent thrombosis, 4. non-fatal ischemic stroke, and 5. major bleeding (BARC 3-5) requir-ing hospitalization.
Secondary Outcomes
- Time to first intracranial and other major (BARC 3-5) bleeding events requiring hospitalization
- 1. Number of cardiovascular deaths 2. Number of re-hospitalizations for non-fatal intracranial bleeding 3. Number of re-hospitalizations for non-fatal myocardial infarctions including stent thrombosis 4. Number of re-hospitalizations for non-fatal ischemic stroke 5. Number of re-hospitalizations for major bleeding (BARC 3-5)
- Time to first myocardial infarction including stent thrombosis, ischemic stroke, and mortality due to is-chemic events
- The proportion of patients in the aspirin continuation group who filled at least two prescriptions from one month before to six months after randomization. Pa-tients randomized to no aspirin therapy were considered adherent unless they redeem an aspirin pre-scription within six months after randomization
Investigators
John Drammen Munkhaugen
Scientific
Vestre Viken HF
Study Sites (9)
Loading locations...
Identifiers
- EU CT number
- 2026-526941-91-00
- Other Study IDs
- RELASE
Dates
- First Posted
- (15 days ago)
- Study Completion
- (in 4 years)
- Last updated
- (15 days ago)
Regulatory & Sharing
- Has Results
- No
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