Acute Coronary SyndromePhase 4SORT OUT DAPTNCT06718179
Comparison of Short Versus 12 Months Prasugrel Plus Aspirin in Patients With Acute Coronary Syndromes Treated With Percutaneous Coronary Intervention and Everolimus-eluting Stents
A Phase 4 study testing Short duration of aspirin and prasugrel and Conventional duration of aspirin and prasugrel in people with Acute Coronary Syndrome, run by Odense University Hospital at 3 sites in Denmark.
Trial summary
The SORT OUT XII dual antiplatelet treatment (DAPT) duration trial, is a clinical randomized controlled superiority and non-inferiority trial to compare whether prasugrel alone versus prasugrel plus aspirin from month 1 to month 12 after percutaneous coronary intervention with and everolimus-eluting stent in patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Short duration of aspirin and prasugrel and Conventional duration of aspirin and prasugrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 3 sitesDenmark
- Study dates
- 16 Nov 2024to 30 May 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients aged ≥18 years with acute coronary syndromes who are treated with an everolimus-eluting drug-eluting stent can undergo randomization if they can be treated with prasugrel for 12 months.
- Postmenopausal women or use of contraceptive drugs (absence of menstruation in at least 12 consecutive months or continuously usage of contraceptive drugs (a contraceptive implant, an intrauterine device, birth-control pills, transdermal patches, vaginal ring, or depot injection).
Who cannot join
- Age < 18 years
- Not able to consent to study participating (eg. intubated patients)
- Do not speak Danish
- Life expectancy <1 year
- Allergic to study related treatment
- Non-vitamin K antagonist oral anticoagulants (NOAC) or warfarin treatment
- Contraindication for 12 months prasugrel treatment
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Aalborg University Hospital
Aalborg, 9000
Aarhus University Hospital
Aarhus, 8200
Odense University Hospital
Odense, 5000
About this study
Official title: Randomized Comparison of Short Versus 12 Months Prasugrel Plus Aspirin in Patients With Acute Coronary Syndromes Treated With Percutaneous Coronary Intervention and Everolimus-eluting Stents (SORT OUT XII DAPT Duration Trial)
The SORT OUT XII dual antiplatelet treatment (DAPT) duration trial, is a clinical randomized controlled superiority and non-inferiority trial to compare whether prasugrel alone versus prasugrel plus aspirin from month 1 to month 12 after percutaneous coronary intervention with and everolimus-eluting stent in patients with acute coronary syndromes (1) is superior regarding clinically relevant bleeding and (2) non-inferior regarding safety (cardiac death, myocardial infarction, definite stent thrombosis, ischemic stroke or clinically driven target lesion revascularization)
- Conditions
- Acute Coronary Syndrome
- Being tested
- Short duration of aspirin and prasugrel, Conventional duration of aspirin and prasugrel
- Keywords
- Drug-eluting stent, Dual antiplatelet treatment
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short duration of aspirin and prasugrelDrug
aspirin 75 mg/day for 1 months plus prasugrel 10 mg/day (5 mg/day) for 1 year, followed by lifelong aspirin 75 mg/day after 1 year
Conventional duration of aspirin and prasugrelDrug
aspirin 75 mg/day lifelong plus prasugrel 10 mg/day (5 mg/day) for 1 year
| Study group | Role | What they receive |
|---|---|---|
| Short duration of DAPT | Experimental | Not described Receives: Drug: Short duration of aspirin and prasugrel |
| Conventional duration of DAPT | Active comparator | Not described Receives: Drug: Conventional duration of aspirin and prasugrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with clinically relevant bleeding (Effectiveness)
Clinically relevant bleeding is defined a "Bleeding Academic Research Consortium" (BARC) where BARC group 2, 3 and 5 are registered
Measured: 1 year
Number of patients with a composite major adverse cardiovascular or cerebrovascular events (Safety)
Major adverse cardiovascular or cerebrovascular events (MACCE) is defined as a composite of cardiac death, myocardial infarction, definite stent thrombosis, ischemic stroke or clinically driven target lesion revascularization)
Measured: 1 year
Secondary outcomes (9)
Number of patients with clinically relevant bleeding
Clinically relevant bleeding is defined a "Bleeding Academic Research Consortium" (BARC) 2, 3 and 5, where BARC group 2, 3 and 5 are registered
Measured: 1 year
Number of patients with all-cause death
All-cause death is defined as any death
Measured: 1 year
Number of patients with cardiac death
Cardiac death is defined as death resulting from cardiovascular causes: death caused by acute myocardial infarction, death caused by sudden cardiac, including unwitnessed, death, death resulting from heart failure, death caused by cardiovascular procedures. Undetermined cause of death is defined as a death not attributable to any other category because of the absence of any relevant source documents. Such deaths will be classified as cardiovascular for end point determination
Measured: 1 year
Number of patients with myocardial infarction
Myocardial infarction diagnosis follows "The Joint ESC/ACCF/AHA/WHF Task Force on "Third Universal Definition of acute myocardial infarction",which has been adapted by Academy Research Consortium. Acute myocardial infarction not related to other than index lesion is defined as any acute myocardial infarction that is not clearly attributable to a non-target vessel
Measured: 1 year
Number of patients with definite stent thrombosis
Definite stent thrombosis is defined as:
Angiographic confirmation of stent thrombosis. The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent or in a side branch originating from the stented segment and the presence of at least one of the following criteria:
Acute onset of ischemic symptoms at rest New electrocardiographic changes suggestive of acute ischemia Typical rise and fall in cardiac biomarkers (refer to definition of spontaneous myocardial infarction) Or Pathological confirmation of stent thrombosis
Measured: 1 year
Number of patients with target lesion revascularization
Target lesion revascularization is defined as a repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment including the 5-mm margin proximal and distal to the stent
Measured: 1 year
Number of patients with stroke
Ischemic stroke is defined from the Neurologic Academic Research Consortium (Neuro-ARC):
Classification on the basis of symptoms and evidence of CNS injury, including overt (acutely symptomatic) CNS injury (Type 1), covert (acutely asymptomatic) CNS injury (Type 2), and neurological dysfunction (acutely symptomatic) without CNS injury (Type 3)
Measured: 1 year
Health-related quality of life
Health-related quality of life (HRQoL) will be assessed by the health state classifier EQ-5D
Measured: 1 month and 1 year
Angina status
Angina status is based on the Canadian Cardiovascular Society classification system (SaQ)
Measured: 1 month and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start16 Nov 2024
- Primary completion25 May 2025
- Study completion30 May 2025
Why it stopped: Insufficient drug supply (prasugrel)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- 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
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisette O Jensen, MD, Principal investigator, Odense University HospitalEvald H Christiansen, MD, Principal investigator, Aarhus University HospitalAshkan Eftekhari, MD, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718179
- Sponsor's protocol ID
- SORT OUT XII DAPT Duration
- Other IDs
- 2024-515236-69-00
- Acronym
- SORT OUT DAPT
- Status last verified
- Oct 2026
- First submitted
- 12 Nov 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Short Versus 12 Months Prasugrel Plus Aspirin in Patients With Acute Coronary Syndromes Treated With Percutaneous Coronary Intervention and Everolimus-eluting Stents (SORT OUT XII DAPT Duration Trial)
- ClinicalTrials.gov ID
- NCT06718179
- Acronym / sponsor ID
- SORT OUT DAPT / SORT OUT XII DAPT Duration
- Conditions
- Acute Coronary Syndrome
- Keywords
- Drug-eluting stent, Dual antiplatelet treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient drug supply (prasugrel)
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 16 Nov 2024 (actual)
- Primary completion
- 25 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 5 Dec 2024 (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.
The SORT OUT XII dual antiplatelet treatment (DAPT) duration trial, is a clinical randomized controlled superiority and non-inferiority trial to compare whether prasugrel alone versus prasugrel plus aspirin from month 1 to month 12 after percutaneous coronary intervention with and everolimus-eluting stent in patients with acute coronary syndromes (1) is superior regarding clinically relevant bleeding and (2) non-inferior regarding safety (cardiac death, myocardial infarction, definite stent thrombosis, ischemic stroke or clinically driven target lesion revascularization)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short duration of DAPT | Experimental | Drug: Short duration of aspirin and prasugrel |
| Conventional duration of DAPT | Active comparator | Drug: Conventional duration of aspirin and prasugrel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients aged ≥18 years with acute coronary syndromes who are treated with an everolimus-eluting drug-eluting stent can undergo randomization if they can be treated with prasugrel for 12 months.
- Postmenopausal women or use of contraceptive drugs (absence of menstruation in at least 12 consecutive months or continuously usage of contraceptive drugs (a contraceptive implant, an intrauterine device, birth-control pills, transdermal patches, vaginal ring, or depot injection).
Key exclusion criteria (7 listed)
- Age < 18 years
- Not able to consent to study participating (eg. intubated patients)
- Do not speak Danish
- Life expectancy <1 year
- Allergic to study related treatment
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 |
|---|---|---|
| Short duration of aspirin and prasugrelaspirin 75 mg/day for 1 months plus prasugrel 10 mg/day (5 mg/day) for 1 year, followed by lifelong aspirin 75 mg/day after 1 year | Drug | Short duration of DAPT |
| Conventional duration of aspirin and prasugrelaspirin 75 mg/day lifelong plus prasugrel 10 mg/day (5 mg/day) for 1 year | Drug | Conventional duration of DAPT |
Primary outcome
Number of patients with clinically relevant bleeding (Effectiveness)
Time frame: 1 year
Clinically relevant bleeding is defined a "Bleeding Academic Research Consortium" (BARC) where BARC group 2, 3 and 5 are registered
Number of patients with a composite major adverse cardiovascular or cerebrovascular events (Safety)
Time frame: 1 year
Major adverse cardiovascular or cerebrovascular events (MACCE) is defined as a composite of cardiac death, myocardial infarction, definite stent thrombosis, ischemic stroke or clinically driven target lesion revascularization)
9 secondary outcomes
Number of patients with clinically relevant bleeding
Time frame: 1 year
Number of patients with all-cause death
Time frame: 1 year
Number of patients with cardiac death
Time frame: 1 year
Number of patients with myocardial infarction
Time frame: 1 year
Number of patients with definite stent thrombosis
Time frame: 1 year
Number of patients with target lesion revascularization
Time frame: 1 year
Number of patients with stroke
Time frame: 1 year
Health-related quality of life
Time frame: 1 month and 1 year
Angina status
Time frame: 1 month and 1 year
Results and safety
The study was stopped early (reason given: Insufficient drug supply (prasugrel)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
Lisette O Jensen, MD principal investigator
Odense University Hospital
Evald H Christiansen, MD principal investigator
Aarhus University Hospital
Ashkan Eftekhari, MD principal investigator
Aalborg University Hospital
3 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 Short duration of aspirin and prasugrel and Conventional duration of aspirin and prasugrel in people with Acute Coronary Syndrome, run by Odense University Hospital at 3 sites in Denmark.
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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 22 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 3 sites in Denmark. 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?
The study was stopped early (reason given: Insufficient drug supply (prasugrel)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with clinically relevant bleeding (Effectiveness) (time frame: 1 year). The study lists 2 primary outcomes in all. 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 22 Oct 2026.