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

Condition studied

Chronic coronary syndrome

Investigational medicinal product(s)

Eligibility

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.

Endpoint detail

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