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 DAPT)

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)

Study Overview

• Status: Recruiting
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Drug: Short duration of aspirin and prasugrel; Drug: Conventional duration of aspirin and prasugrel

• Study Type: Interventional
• Enrollment (Estimated): 3150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Lisette O Jensen, MD; Phone Number: +4565412690; Email: lisette.okkels.jensen@rsyd.dk
• Study Contact Backup: Name: Evald H Christiansen, MD; Phone Number: +4578450000; Email: evald.christiansen@rm.dk

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Not yet recruiting
    • Aalborg University Hospital
    • Contact: Ashkan Eftekhari, MD; Phone Number: 4528973764
  • Aarhus, Denmark, 8200
    • Recruiting
    • Aarhus University Hospital
    • Contact: Evald Christiansen, MD; Phone Number: 4561655176; Email: evald.christiansen@rm.dk
  • Odense, Denmark, 5000
    • Recruiting
    • Odense University Hospital
    • Contact: Lisette Okkels Jensen, MD; Phone Number: 4565412690; Email: lisette.okkels.jensen@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Short duration of DAPT	Drug: Short 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
Active Comparator: Conventional duration of DAPT	Drug: Conventional duration of aspirin and prasugrel; aspirin 75 mg/day lifelong plus prasugrel 10 mg/day (5 mg/day) for 1 year

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year
Number of patients with all-cause death	All-cause death is defined as any death	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	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	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	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	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)	1 year
Health-related quality of life	Health-related quality of life (HRQoL) will be assessed by the health state classifier EQ-5D	1 month and 1 year
Angina status	Angina status is based on the Canadian Cardiovascular Society classification system (SaQ)	1 month and 1 year

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Investigators: Principal Investigator: Lisette O Jensen, MD, Odense University Hospital; Principal Investigator: Evald H Christiansen, MD, Aarhus University Hospital; Principal Investigator: Ashkan Eftekhari, MD, Aalborg University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2024
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: November 12, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Actual): December 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Drug-eluting stent; Dual antiplatelet treatment
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Disease; Myocardial Ischemia; Syndrome; Acute Coronary Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Fibrin Modulating Agents; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Antipyretics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Fibrinolytic Agents; Platelet Aggregation Inhibitors; Prasugrel Hydrochloride; Aspirin
• Other Study ID Numbers: SORT OUT XII DAPT Duration; 2024-515236-69-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No