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The RELEASE Trial: Reconsidering Long-Term Aspirin in the Elderly in Secondary Prevention of Cardiovascular Disease

Status
Not yet recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-525442-30-00
Enrollment
7000
Registered
2026-07-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-07-06

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

Conditions

coronary artery bypass grafting), Ischemic heart disease/Chronic coronary syndrome (Myocardial infarction, percutaneous coronary intervention

Brief summary

The following components are included in the primary endpoint, ranked in hierarchical order: 1. Cardiovascular death 2. Fatal bleeding (BARC type 5) 3. Intracranial bleeding (BARC type 3c) 4. Ischemic stroke 5. MI 6. Other major bleeding (BARC type 3a [moderate, requires transfusion] and 3b [major, may need surgery])

Detailed description

The secondary endpoints of the trial are listed below: - Each component of the primary composite outcome - All-cause mortality - Hospitalization for cardiovascular causes - Peptic ulcer - Patient-reported outcomes o Minor bleeding o Abdominal pain/discomfort o Quality of life o Health-related quality of life, anxiety and depressive symptoms, and functional status o Angina symptoms o Lifestyle behaviour

Interventions

DRUGMagnyl DAK
DRUGenterotabletter

Sponsors

Odense University Hospital
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The following components are included in the primary endpoint, ranked in hierarchical order: 1. Cardiovascular death 2. Fatal bleeding (BARC type 5) 3. Intracranial bleeding (BARC type 3c) 4. Ischemic stroke 5. MI 6. Other major bleeding (BARC type 3a [moderate, requires transfusion] and 3b [major, may need surgery])

Secondary

MeasureTime frame
The secondary endpoints of the trial are listed below: - Each component of the primary composite outcome - All-cause mortality - Hospitalization for cardiovascular causes - Peptic ulcer - Patient-reported outcomes o Minor bleeding o Abdominal pain/discomfort o Quality of life o Health-related quality of life, anxiety and depressive symptoms, and functional status o Angina symptoms o Lifestyle behaviour

Outcome results

None listed

Source: EU CTIS · Data processed: Jul 7, 2026