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

ConditionsIschemic 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 Non-inferiority Trial

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age65+

SponsorOdense University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Continuation of daily low-dose Aspirin
Drug
Participants randomized to this intervention will continue their current daily low-dose aspirin therapy.
Discontinuation of daily low-dose Aspirin
Drug
Participants randomized to this intervention will discontinue their current daily low-dose aspirin therapy.

Treatment groups

7,000 Participants

are divided into 2 treatment groups

Group A: Continuation of AspirinActive comparator 1 intervention

Group B: Discontinuation of AspirinActive comparator 1 intervention

Trial outcomes

Primary outcomes

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).

Time frame