See if stopping long-term aspirin is as good as continuing it in older adults with stable ischemic heart disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

DAN-RELEASE is a national Denmark randomized, registry-based trial enrolling about 7,000 participants to compare discontinuation versus continuation of daily low-dose aspirin in adults aged 65 and above who have stable ischemic heart disease and have been event-free for at least two years. The study uses a non-inferiority design to determine whether stopping aspirin is not worse than ongoing therapy in preventing ischemic or bleeding events, leveraging existing registry data for efficiency. Eligible participants are those with a prior MI, PCI, or CABG, currently on aspirin, and without recent ischemic events or other anticoagulant indications. The trial aims to modernize long-term secondary prevention in an era of evolving revascularization strategies and improved secondary prevention. Lead sites include Odense University Hospital and collaborations with University Hospital Bispebjerg and Frederiksberg.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Where it's running

• Bispebjerg Frederiksberg Hospital
  Copenhagen, Denmark Recruiting
• Odense Universitetshospital
  Odense, Denmark Recruiting

Study contacts

• Study coordinator: Axel Diederichsen, Professor
• Email: Axel.Diederichsen@rsyd.dk
• Phone: +4540191227

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.