Acute Coronary Syndrome
Conditions
Keywords
Drug-eluting stent, Dual antiplatelet treatment
Brief 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 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)
Interventions
DRUGShort duration of aspirin and prasugrel
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
DRUGConventional duration of aspirin and prasugrel
aspirin 75 mg/day lifelong plus prasugrel 10 mg/day (5 mg/day) for 1 year
Sponsors
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with clinically relevant bleeding (Effectiveness) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with cardiac death | 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 |
| Number of patients with myocardial infarction | 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 |
| Number of patients with definite stent thrombosis | 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 |
| Number of patients with clinically relevant bleeding | 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 |
| Number of patients with stroke | 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) |
| Health-related quality of life | 1 month and 1 year | Health-related quality of life (HRQoL) will be assessed by the health state classifier EQ-5D |
| Angina status | 1 month and 1 year | Angina status is based on the Canadian Cardiovascular Society classification system (SaQ) |
| Number of patients with target lesion revascularization | 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 |
| Number of patients with all-cause death | 1 year | All-cause death is defined as any death |
Countries
Denmark
Contacts
Primary ContactLisette O Jensen, MD
Backup ContactEvald H Christiansen, MD
Outcome results
None listed