DAN-RELEASE - Reconsidering Long-Term Aspirin in the Elderly Patients With Stable Ischemic Heart Disease

NCT07795398 | Not Yet Recruiting Phase 4 DMC

• 2 other identifiers: 2026-525442-302026-525442-30-00
• Study Type: interventional
• Target: 7,000
• Locations: 1 country
• Sites: 1

Brief Summary

DAN-RELEASE is a national, randomized, registry-based trial including 7,000 participants in Denmark. The trial aims to determine whether discontinuation of long-term aspirin therapy is non-inferior to continued aspirin therapy in older adults with stable ischemic heart disease. Long-term aspirin therapy is recommended for patients with established ischemic heart disease. However, among clinically stable patients years after percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), or myocardial infarction (MI), the evidence supporting lifelong aspirin therapy is limited. At the same time, the risk of serious bleeding increases with age. DAN-RELEASE will therefore compare aspirin discontinuation with continued aspirin therapy in adults aged 65 years or older with stable ischemic heart disease who have remained free from ischemic events for at least two years. The trial will assess whether discontinuing aspirin is non-inferior to continued treatment with respect to cardiovascular and bleeding outcomes.

Conditions

Non-inferiority Trial; Ischemic Heart Disease; Ischemic Heart Disease Chronic; Chronic Coronary Syndrome; Myocardial Infarction; Percutaneous Coronary Intervention; Coronary Artery Bypass Graft; Aspirin; Aspirin Causing Adverse Effects in Therapeutic Use

Keywords

Ischemic heart disease; Chronic coronary syndrome

Outcome Measures

Primary Outcomes (1)

• Hierarchical Composite of Cardiovascular and Bleeding Events

  A hierarchical composite endpoint using a win-ratio framework combining cardiovascular death, fatal bleeding, intracranial bleeding, Myocardial infarction, ischemic stroke, and bleeding events (BARC 3-5).

  From randomization until the end of the study, with a minimum follow-up of 1 year

Secondary Outcomes (13)

• Cardiovascular Death

  From randomization until the end of the study, with a minimum follow-up of 1 year

• Fatal Bleeding (BARC Type 5)

  From randomization until the end of the study, with a minimum follow-up of 1 year

• Intracranial Bleeding (BARC Type 3c)

  From randomization until the end of the study, with a minimum follow-up of 1 year

• Ischemic Stroke

  From randomization until the end of the study, with a minimum follow-up of 1 year

• Myocardial Infarction

  From randomization until the end of the study, with a minimum follow-up of 1 year

Study Arms (2)

Continuation of Aspirin

ACTIVE COMPARATOR

Participants randomized to this arm will continue their current long-term low-dose aspirin therapy.

Drug: Continuation of daily low-dose Aspirin

Discontinuation of Aspirin

ACTIVE COMPARATOR

Participants randomized to this arm will discontinue their current long-term low-dose aspirin therapy.

Drug: Discontinuation of daily low-dose Aspirin

Interventions

Continuation of daily low-dose Aspirin DRUG

Participants randomized to this intervention will continue their current daily low-dose aspirin therapy.

Also known as: continuation of Aspirin

Continuation of Aspirin

Discontinuation of daily low-dose Aspirin DRUG

Participants randomized to this intervention will discontinue their current daily low-dose aspirin therapy.

Also known as: Discontinuation of Aspirin

Discontinuation of Aspirin

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥65 years at randomization
• Ischemic heart disease (IHD) with index event (myocardial infarction (MI), percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG)) \>2 years previously
• Since index event free from ischemic cardiovascular events (MI, ischemic stroke, or transitory ischemic attack) or any coronary revascularization procedure (PCI/CABG)
• Currently treated with low dose aspirin (≤150 mg daily)

You may not qualify if:

• History of ischemic stroke
• Active treatment with or indication for anti-coagulant or P2Y12-inhibitor therapy
• Indication for antiplatelet treatment other than secondary prevention of IHD according to treating physician (i.e. haematological diseases, peripheral artery disease)
• Any revascularization procedure for peripheral artery disease
• Any history of stent thrombosis or stenting of the left main coronary artery
• Other contraindications to aspirin discontinuation according to treating physician
• Not being able to understand Danish

Sponsors & Collaborators

• Odense University Hospital: lead
• University Hospital Bispebjerg and Frederiksberg: collaborator

Study Sites (1)

Odense Universitetshospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Myocardial Ischemia; Myocardial Infarction

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Axel Diederichsen, Professor

CONTACT

+4540191227; Axel.Diederichsen@rsyd.dk

Eva Prescott, Professor

CONTACT

+4540262134; eva.irene.bossano.prescott@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized 1:1 to continuation or discontinuation of low-dose aspirin.

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start: September 14, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)