A Phase 4 interventional study of Continuation of daily low-dose Aspirin and Discontinuation of daily low-dose Aspirin in Ischemic Heart Disease, Ischemic Heart Disease Chronic and Chronic Coronary Syndrome, sponsored by Odense University Hospital. Recruiting at 2 sites in Denmark. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Odense University Hospital · Phase 4, Interventional, and Treatment
Among 10 studies in Myocardial Infarction by Odense University Hospital — 2 open to participants now, 3 under way, none of them phase 3. Myocardial Infarction · Odense University Hospital.
Among the 10 studies in Myocardial Infarction by Odense University Hospital, this one has the largest planned enrollment, is the only one that started in 2026, is one of 2 in phase 4, and was the 10th registered.
2,270 studies on the registry are indexed under Myocardial Infarction; 371 are open to participants now.
This study's planned enrollment of 7,000 is above the median of 150 across 1,314 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →2 of the 10 studies in Myocardial Infarction by Odense University Hospital are open now, in 1 country. Each count lists the studies.
Of the 255 Myocardial Infarction studies recruiting now, 172 (67%) set no upper age limit and 26 (10%) stop at 75 or younger; 16 take children under 18; 27 take healthy volunteers.
This study: 65 Years and older · all sexes · no healthy volunteers.
The full table on the hub →10 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 1 started in 2026.
Median enrollment 94 across the 10 interventional studies. Of the 5 that completed or were terminated, 0 (0%) have results posted.
Odense University Hospital is the lead sponsor of 479 studies on the registry; 110 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Myocardial Infarction by Odense University Hospital, from their registry updates:
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.
Rationale:
Current guidelines recommend life-long aspirin therapy in patients with chronic coronary syndrome. The evidence supporting long-term aspirin therapy after myocardial infarction (MI) and for chronic coronary syndrome stems primarily from trials conducted in the 1970s and 1980s. Since then, the clinical landscape of MI has evolved markedly: The use of highly sensitive cardiac troponins has led to the diagnosis of smaller MIs, coinciding with a shift from predominantly large ST-segment elevation MI (STEMI) to smaller non-STEMI. Acute revascularization is now a part of the routine care for MI and many patients with stable coronary artery disease undergo percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). Population risk factors have improved, and universal use of statins have contributed to plaque stabilization and reduces progression of disease. As a result, long-term prognosis in patients with MI and chronic coronary syndromes has markedly improved.
Therefore, the absolute ischemic benefit of long-term aspirin therapy may be attenuated, while the risk of bleeding, particularly in older patients, remains clinically relevant. These developments warrant a contemporary re-evaluation of the life-long role of aspirin in long-term secondary prevention of cardiovascular disease, especially in elderly patients with stable disease.
Objective:
To evaluate whether discontinuation of long-term aspirin in elderly patients with stable chronic coronary syndrome is non-inferior to continued aspirin therapy with respect to net clinical outcome.
All clinical outcomes will be registry based except patient-reported outcomes. They will be assessed using questionnaires measuring bleeding symptoms, gastrointestinal discomfort, quality of life and lifestyle behaviour during follow-up.
Trial design:
Investigator-initiated, registry-based, prospective, randomized, open-label, blinded endpoint (PROBE) non-inferiority trial with 1:1 allocation. The trial is conducted as a low-intervention clinical trial using nationwide Danish health registries as the primary data source.
Risk-benefit considerations:
Aspirin is widely used in secondary prevention and is available over the counter, reflecting its well established safety profile and the generally low risk associated with its use. Nevertheless, aspirin is associated with potential adverse effects, including bleeding, gastrointestinal discomfort, and clinically relevant drug interactions, particularly in elderly patients with comorbidities. Based on data from national health registries, the target population - older adults with stable chronic coronary syndrome - represents a clinically stable group with a low event rate of ischemic events. Given that lifelong aspirin therapy is often continued without systematic reassessment, there is a clear ethical justification for evaluating whether continuation remains beneficial - and safe - in an aging population with changing comorbidity profiles.
2,270 studies on the registry are indexed under Myocardial Infarction; 371 are open to participants now.
This study's planned enrollment of 7,000 is above the median of 150 across 1,314 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Odense University Hospital is the lead sponsor of 479 studies on the registry; 110 are open to participants now.
Compared within Myocardial Infarction, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Myocardial Ischemia. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to this arm will continue their current long-term low-dose aspirin therapy.
Drug: Continuation of daily low-dose Aspirin
Participants randomized to this arm will discontinue their current long-term low-dose aspirin therapy.
Drug: Discontinuation of daily low-dose Aspirin
Participants randomized to this intervention will continue their current daily low-dose aspirin therapy.
Also known as: continuation of Aspirin
Participants randomized to this intervention will discontinue their current daily low-dose aspirin therapy.
Also known as: Discontinuation of Aspirin
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: From randomization until the end of the study, with a minimum follow-up of 1 year
Cardiovascular Death
Death due to a cardiovascular cause.
Time frame: From randomization until the end of the study, with a minimum follow-up of 1 year
Fatal Bleeding (BARC Type 5)
Fatal bleeding classified as Bleeding Academic Research Consortium (BARC) type 5.
Time frame: From randomization until the end of the study, with a minimum follow-up of 1 year
Intracranial Bleeding (BARC Type 3c)
Intracranial bleeding classified as Bleeding Academic Research Consortium (BARC) type 3c.
Time frame: From randomization until the end of the study, with a minimum follow-up of 1 year
Ischemic Stroke
Occurrence of ischemic stroke during follow-up.
Time frame: From randomization until the end of the study, with a minimum follow-up of 1 year
Myocardial Infarction
Occurrence of myocardial infarction during follow-up.
Time frame: From randomization until the end of the study, with a minimum follow-up of 1 year
Other Major Bleeding (BARC Types 3a and 3b)
Major bleeding classified as Bleeding Academic Research Consortium (BARC) types 3a or 3b.
Time frame: From randomization until the end of the study, with a minimum follow-up of 1 year
All-Cause Mortality
Death from any cause during follow-up.
Time frame: From randomization until the end of the study, with a minimum follow-up of 1 year
Hospitalization for Cardiovascular Causes
Hospitalization due to cardiovascular causes during follow-up.
Time frame: From randomization until the end of the study, with a minimum follow-up of 1 year
Peptic Ulcer
Occurrence of peptic ulcer during follow-up.
Time frame: From randomization until the end of the study, with a minimum follow-up of 1 year
Minor Bleeding
Patient-reported bleeding symptoms will be assessed using a modified version of the International Society on Thrombosis and Haemostasis Scientific and Standardization Committee Bleeding Assessment Tool (ISTH/SSC-BAT). The questionnaire is used to collect information on bleeding symptoms not available from national health registries.
Time frame: From randomization until the end of the study, with a minimum follow-up of 1 year
Abdominal Pain and Discomfort
Patient-reported abdominal pain and gastrointestinal discomfort during follow-up, including symptom burden and impact on daily life. Individual questionnaire items are assessed separately, and no overall scale score is calculated.
Time frame: Baseline and 3, 6, 12, and 24 months after randomization
Quality of Life (EQ-5D-5L)
Patient-reported health-related quality of life assessed using the EQ-5D-5L (EuroQol 5-Dimension 5-Level) questionnaire. The descriptive system covers five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on five levels, ranging from no problems (level 1) to extreme problems or inability (level 5), with higher levels indicating worse health status. The responses to the five dimensions are combined into a five-digit health state. The direct sum of the 5 individual dimension scores. Higher means worse health status. The EQ Visual Analogue Scale (EQ VAS) records the participant's self-rated health on a scale from 0 to 100, where 0 represents the worst health imaginable and 100 represents the best health imaginable. Higher EQ VAS scores indicate better self-rated health.
Time frame: Baseline and 3, 6, 12, and 24 months after randomization
Angina Symptoms, Frequency, and Physical Limitations (Seattle Angina Questionnaire)
Patient-reported angina symptoms, frequency, and physical limitations assessed using the 7-item Seattle Angina Questionnaire (SAQ-7). Scores are transformed to a scale from 0 to 100, with higher scores indicating better health status and fewer limitations due to angina.
Time frame: Baseline and 3, 6, 12, and 24 months after randomization
Plan to share: No — Due to data protection requirements, individual participant data are not planned to be shared outside the study research group.
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Oct 2029, 37 months after the start.
Of 83 non-industry phase 4 interventional studies under Myocardial Infarction, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 78. This study's planned 37 months is below that.
Counting every sponsor, half of 87 studies reached it within 42 months; a quarter within 22 and three quarters within 78.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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