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NCT Number: NCT06718179

Comparison of Short Versus 12 Months Prasugrel Plus Aspirin in Patients with Acute Coronary Syndromes Treated with Percutaneous Coronary Intervention and Everolimus-eluting Stents

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)

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aalborg University Hospital, Aalborg, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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

Treatment and study plan

Short duration of aspirin and prasugrel

Drug

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 prasugrel

Drug

aspirin 75 mg/day lifelong plus prasugrel 10 mg/day (5 mg/day) for 1 year

Primary outcomes

  1. 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

  2. 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)

Secondary outcomes

  1. Number of patients with clinically relevant bleeding

    Time frame: 1 year

    Clinically relevant bleeding is defined a "Bleeding Academic Research Consortium" (BARC) 2, 3 and 5, where BARC group 2, 3 and 5 are registered

  2. Number of patients with all-cause death

    Time frame: 1 year

    All-cause death is defined as any death

  3. Number of patients with cardiac death

    Time frame: 1 year

    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

  4. Number of patients with myocardial infarction

    Time frame: 1 year

    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

  5. Number of patients with definite stent thrombosis

    Time frame: 1 year

    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

  6. Number of patients with target lesion revascularization

    Time frame: 1 year

    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

  7. Number of patients with stroke

    Time frame: 1 year

    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)

  8. Health-related quality of life

    Time frame: 1 month and 1 year

    Health-related quality of life (HRQoL) will be assessed by the health state classifier EQ-5D

  9. Angina status

    Time frame: 1 month and 1 year

    Angina status is based on the Canadian Cardiovascular Society classification system (SaQ)

Study contacts

Contact information is provided by the study sponsor or research team.

Evald H Christiansen, MD

CONTACT

[email protected]

+4578450000

Lisette O Jensen, MD

CONTACT

[email protected]

+4565412690

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study 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)

Acronym: SORT OUT DAPT

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
Dec 5, 2024
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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