Coronary Arterial Disease (CAD)Phase 4RELEASE-NorwayNCT07854795
Reconsidering Long-Term Apirin in the Elderly in Secondary Prevention of Coronary Artery Disease Norway
A Phase 4 study testing Discontinuation of aspirin (ATC-code B01AC06 and N02BA01) in people with Coronary Arterial Disease (CAD), run by Vestre Viken Hospital Trust at 9 sites in Norway.
Trial summary
Lifelong aspirin has been a cornerstone of secondary prevention after coronary artery disease (CAD), based on trials conducted 40-50 years ago. Since then, major advances in coronary reperfusion and risk factor management have significantly improved outcomes. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Coronary Arterial Disease (CAD)
- What is being tested?
- Discontinuation of aspirin (ATC-code B01AC06 and N02BA01)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,000 participants
- Where
- 9 sitesNorway
- Study dates
- 1 Feb 2027to 1 Dec 2031
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥65 years at randomization treated with low-dose (≤150 mg/day) aspirin
- An ACS event treated with PCI 2-8 years prior to randomisation and no ischemic cardiovascular event (MI or stroke) or any coronary revascularization procedure (PCI/coronary artery bypass grafting) since index event
- Signed informed consent and expected cooperation according to ICH/GCP and national/local regulations
Who cannot join
- Indication for antiplatelet treatment other than secondary prevention of CAD (i.e. haematological diseases, stroke, PAD)
- Active treatment with or indication for anti-coagulant or P2Y12-inhibitor therapy
- Left main stenosis or any history of stent thrombosis, or other contraindications to discontinuation of aspirin according to treating physician
- Any condition (e.g. drug/alcohol abuse, dementia) or situation, that in the investigator's opinion could put the subject at signifi-cant risk directly related to the randomized aspirin strategy, confound the results, interfere significantly with participation, or render informed consent unfeasible. Investigators are explicitly encouraged not to exclude patients solely due to advanced age, frailty or polypharmacy if equipoise exists regarding aspirin continuation vs. discontinuation and informed consent is feasible.
- Life expectancy <12 months due to non-cardiac reasons or not being able to understand Norwegian or English language
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Norway9 sites
Sørlandet Hospital Trust Arendal
Arendal, 4838
Jarle Jortveit, MD, PhD, +47 99 45 07 14, jarle.jortveit@gmail.com
Haukeland University Hospital
Bergen, 5009
Erlend Eriksen, MD, PhD, +47 924 01 107, erlend.eriksen@helse-bergen.no
Drammen hospital
Drammen, 3004
Elise Sverre, MD, PhD, +4799020329, elise.christine.bjorkholen.sverre@vestreviken.no
Akershus University Hospital
Lørenskog, 1478
Henrik Schirmer, MD, PhD, +47 99 26 43 38, henrik.schirmer@medisin.uio.no
Oslo University Hospital Rikshospitalet
Oslo, 0372
Peder Peder Myhre, MD, PhD, +47 93 02 56 44, pedmyh@ous-hf.no
Oslo University Hospital Ullevaal
Oslo, 0450
Sigrun Halvorsen, MD, PhD, +4791317460, sigrun.halvorsen@medisin.uio.no
Stavanger Universty Hospital
Stavanger, 4068
Alf Inge Larsen, MD, PhD, +47 958 89 896, alf.inge.larsen@sus.no
University Hospital of North Norway Tromsø
Tromsø, 9019
Kristina Fladseth, MD, PhD, +47 98412227, kristina.fladseth@gmail.com
St. Olavs Hospital
Trondheim, 7030
Erik Madssen, MD, PhD, +4795927169, Erik.Madssen@stolav.no
About this study
Official title: REconsidering Long-TErm ASpirin in the Elderly in Secondary Prevention of Coronary Artery Disease (RELEASE) Norway: A Randomised, Registry-based Trial
Lifelong aspirin has been a cornerstone of secondary prevention after coronary artery disease (CAD), based on trials conducted 40-50 years ago. Since then, major advances in coronary reperfusion and risk factor management have significantly improved outcomes. At the same time, aspirin is clearly associated with an increased risk of major bleeding, including intracranial haemorrhage. This raises a critical, yet unanswered question: in patients more than 2 years after a CAD event, does the benefit of continued aspirin still outweigh its bleeding risk? RELEASE-Norway is an investigator-initiated, registry-based, randomised trial with blinded endpoint assessment (PROBE design) designed to determine whether patients with chronic CAD can safely stop aspirin without losing cardiovascular protection. The trial will randomise 7,000 patients from all major hospitals in Norway. Together with a similar trial (RELEASE-Denmark, n≈7,000) planned in Denmark, the study will provide definitive evidence on the long-term net clinical benefit versus harm of aspirin in stable CAD and most likely directly inform future guidelines and clinical practice worldwide. Imaging and PROMS sub-studies will explore clinical and psychosocial mechanisms, providing insight into treatment heterogeneity and enabling future personalised antiplatelet therapy. Additionally, a health-economic analysis will assess the cost-effectiveness of discontinuing aspirin for healthcare systems.
- Conditions
- Coronary Arterial Disease (CAD)
- Being tested
- Discontinuation of aspirin (ATC-code B01AC06 and N02BA01)
- Keywords
- RELEASE, Aspirin, PCI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discontinuation of aspirin (ATC-code B01AC06 and N02BA01)Drug
Patients will be randomized open-label 1:1 to either continuation of low-dose oral aspirin (Anatomical Therapeutic Chemical codes B01AC06 and N02BA01) at a daily dose of ≤150 mg (no intervention group) or discontinuation of aspirin therapy (intervention group). If the patient is randomized to discontinuing aspirin the treatment will be discontinued from their medical list. All participants will receive lifestyle advice and appropriate follow-up, as recommended.
| Study group | Role | What they receive |
|---|---|---|
| Aspirin discontinuation | Experimental | Patients in the intervention group will be randomized to discontinuing aspirin treatment. The drug will be discontinued from their medical list. All participants will receive lifestyle advice and appropriate follow-up, as recommended. Receives: Drug: Discontinuation of aspirin (ATC-code B01AC06 and N02BA01) |
| Aspirin continuation (ATC-codes B01AC06 and N02BA01) | No intervention | Patients will be randomized to continuation of of low-dose oral aspirin (Anatomical Therapeutic Chemical codes B01AC06 and N02BA01) at a daily dose of ≤150 mg (usual care, no intervention). All participants will receive lifestyle advice and appropriate follow-up, as recommended. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hierarchical composite endpont
The net clinical benefit of discontinuing versus continuing aspirin in patients randomized 2-8 years after an index ACS event, using a hierarchical composite endpoint with a win-ratio framework that includes: 1. Cardiovascular death, 2. Intracranial bleeding, 3. Myocardial infarctions including stent thrombosis, 4. Ischemic stroke, 5. Major bleeding (BARC 3 and 5) requiring hospitalization. The components of the endpoints will be identified in The Norwegian Patient Registry and Cause of Death Registry using procedure and diagnostic codes.
Measured: From randomization to median 3.0 (minimum 1.0) years follow-up
Secondary outcomes (2)
Risk of ischaemic disease
The cumulative risk of a composite of recurrent myocardial infarction including stent thrombosis, ischemic stroke, and cardiovascular death by randomization group. Events will be identified in the Norwegian Patient Registry and the Norwegian Cause of Death registry using procedure and diagnostic codes.
Measured: From randomization to median 3.0 (minimum 1.0) years follow-up
Risk of major bleedings
The cumulative risk of major bleedings, including intracranial and other major (BARC 3, 5) bleeding events requiring hospitalization by randomization group. Events will be identified in The Norwegian Patient Registry and the Cause of Death registry data with procedure and diagnostic codes.
Measured: From randomization to median 3.0 (minimum 1.0) years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start1 Feb 2027 (estimated)
- Primary completion1 Dec 2030 (estimated)
- Study completion1 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Arterial Disease (CAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vestre Viken Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo Universitetssykehus Hospital Trust, Akershus University Hospital Trust, Sorlandet Hospital HF, Helse Stavanger HF, Helse-Bergen HF, St. Olavs Hospital, Norwegian Health Association, Landsforeningen for hjerte og lungesyke (LHL), Bispebjerg Hospital, Odense University Hospital, University of Oslo, University Hospital of North Norway
- Responsible party
- Sponsor
- Investigators
- John Munkhaugen, MD, PhD, Principal investigator, Vestre Viken HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854795
- Sponsor's protocol ID
- 2026-526941-91-00
- Other IDs
- 2026-526941-91-00
- Acronym
- RELEASE-Norway
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant-level data cannot be made publicly available due to data protection regulations and applicable Norwegian legislation.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REconsidering Long-TErm ASpirin in the Elderly in Secondary Prevention of Coronary Artery Disease (RELEASE) Norway: A Randomised, Registry-based Trial
- ClinicalTrials.gov ID
- NCT07854795
- Acronym / sponsor ID
- RELEASE-Norway / 2026-526941-91-00
- Conditions
- Coronary Arterial Disease (CAD)
- Keywords
- RELEASE, Aspirin, PCI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- Vestre Viken Hospital TrustUniversity, hospital or other
- Collaborators
- Oslo Universitetssykehus Hospital Trust, Akershus University Hospital Trust, Sorlandet Hospital HF, Helse Stavanger HF, Helse-Bergen HF, St. Olavs Hospital, Norwegian Health Association, Landsforeningen for hjerte og lungesyke (LHL), Bispebjerg Hospital, Odense University Hospital, University of Oslo, University Hospital of North Norway
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 1 Dec 2030 (estimated)
- Study completion
- 1 Dec 2031 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lifelong aspirin has been a cornerstone of secondary prevention after coronary artery disease (CAD), based on trials conducted 40-50 years ago. Since then, major advances in coronary reperfusion and risk factor management have significantly improved outcomes. At the same time, aspirin is clearly associated with an increased risk of major bleeding, including intracranial haemorrhage. This raises a critical, yet unanswered question: in patients more than 2 years after a CAD event, does the benefit of continued aspirin still outweigh its bleeding risk? RELEASE-Norway is an investigator-initiated, registry-based, randomised trial with blinded endpoint assessment (PROBE design) designed to determine whether patients with chronic CAD can safely stop aspirin without losing cardiovascular protection. The trial will randomise 7,000 patients from all major hospitals in Norway. Together with a similar trial (RELEASE-Denmark, n≈7,000) planned in Denmark, the study will provide definitive evidence on the long-term net clinical benefit versus harm of aspirin in stable CAD and most likely directly inform future guidelines and clinical practice worldwide. Imaging and PROMS sub-studies will explore clinical and psychosocial mechanisms, providing insight into treatment heterogeneity and enabling future personalised antiplatelet therapy. Additionally, a health-economic analysis will assess the cost-effectiveness of discontinuing aspirin for healthcare systems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin discontinuation | Experimental | Drug: Discontinuation of aspirin (ATC-code B01AC06 and N02BA01)Patients in the intervention group will be randomized to discontinuing aspirin treatment. The drug will be discontinued from their medical list. All participants will receive lifestyle advice and appropriate follow-up, as recommended. |
| Aspirin continuation (ATC-codes B01AC06 and N02BA01) | No intervention | –Patients will be randomized to continuation of of low-dose oral aspirin (Anatomical Therapeutic Chemical codes B01AC06 and N02BA01) at a daily dose of ≤150 mg (usual care, no intervention). All participants will receive lifestyle advice and appropriate follow-up, as recommended. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age ≥65 years at randomization treated with low-dose (≤150 mg/day) aspirin
- An ACS event treated with PCI 2-8 years prior to randomisation and no ischemic cardiovascular event (MI or stroke) or any coronary revascularization procedure (PCI/coronary artery bypass grafting) since index event
- Signed informed consent and expected cooperation according to ICH/GCP and national/local regulations
Key exclusion criteria (5 listed)
- Indication for antiplatelet treatment other than secondary prevention of CAD (i.e. haematological diseases, stroke, PAD)
- Active treatment with or indication for anti-coagulant or P2Y12-inhibitor therapy
- Left main stenosis or any history of stent thrombosis, or other contraindications to discontinuation of aspirin according to treating physician
- Any condition (e.g. drug/alcohol abuse, dementia) or situation, that in the investigator's opinion could put the subject at signifi-cant risk directly related to the randomized aspirin strategy, confound the results, interfere significantly with participation, or render informed consent unfeasible. Investigators are explicitly encouraged not to exclude patients solely due to advanced age, frailty or polypharmacy if equipoise exists regarding aspirin continuation vs. discontinuation and informed consent is feasible.
- Life expectancy <12 months due to non-cardiac reasons or not being able to understand Norwegian or English language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Discontinuation of aspirin (ATC-code B01AC06 and N02BA01)Patients will be randomized open-label 1:1 to either continuation of low-dose oral aspirin (Anatomical Therapeutic Chemical codes B01AC06 and N02BA01) at a daily dose of ≤150 mg (no intervention group) or discontinuation of aspirin therapy (intervention group). If the patient is randomized to discontinuing aspirin the treatment will be discontinued from their medical list. All participants will receive lifestyle advice and appropriate follow-up, as recommended. | Drug | Aspirin discontinuation |
Primary outcome
Hierarchical composite endpont
Time frame: From randomization to median 3.0 (minimum 1.0) years follow-up
The net clinical benefit of discontinuing versus continuing aspirin in patients randomized 2-8 years after an index ACS event, using a hierarchical composite endpoint with a win-ratio framework that includes: 1. Cardiovascular death, 2. Intracranial bleeding, 3. Myocardial infarctions including stent thrombosis, 4. Ischemic stroke, 5. Major bleeding (BARC 3 and 5) requiring hospitalization. The components of the endpoints will be identified in The Norwegian Patient Registry and Cause of Death Registry using procedure and diagnostic codes.
2 secondary outcomes
Risk of ischaemic disease
Time frame: From randomization to median 3.0 (minimum 1.0) years follow-up
Risk of major bleedings
Time frame: From randomization to median 3.0 (minimum 1.0) years follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant-level data cannot be made publicly available due to data protection regulations and applicable Norwegian legislation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Munkhaugen, MD, PhD principal investigator
Vestre Viken HF
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Discontinuation of aspirin (ATC-code B01AC06 and N02BA01) in people with Coronary Arterial Disease (CAD), run by Vestre Viken Hospital Trust at 9 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Munkhaugen, MD, PhD (+47 97524194, johmun@vestreviken.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hierarchical composite endpont (time frame: From randomization to median 3.0 (minimum 1.0) years follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.