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

Phase 4

Not yet recruiting

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: Short duration of aspirin and prasugrel; Drug: Conventional duration of aspirin and prasugrel

• Registration Number: NCT06718179
• Lead Sponsor: Odense University Hospital

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)

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2024-11-12
• Status Verified: 2024-12
• Study Start: 2024-12
• Study First Submitted QC: 2024-12-04
• Last Update Submitted: 2024-12-04
• Study First Posted: 2024-12-05
• Last Update Posted: 2024-12-05
• Primary Completion: 2029-11
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3150

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Short duration of DAPT	Short duration of aspirin and prasugrel	-
Conventional duration of DAPT	Conventional duration of aspirin and prasugrel	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 all-cause death	1 year	All-cause death is defined as any death
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 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 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)