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REconsidering Long-TErm ASpirin in the Elderly in Secondary Prevention of Coronary Artery Disease (RELEASE) Norway: A Randomised, Registry-based Trial

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-526941-91-00
Enrollment
7000
Registered
2026-09-15
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic coronary syndrome

Brief summary

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.

Detailed description

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, Time to first intracranial and other major (BARC 3-5) bleeding events requiring hospitalization, 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

Interventions

Sponsors

Vestre Viken HF
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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, Time to first intracranial and other major (BARC 3-5) bleeding events requiring hospitalization, 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

Outcome results

None listed

Source: EU CTIS · Data processed: Sep 16, 2026