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

NCT06718179 | Recruiting Phase 4 DMC

• 2 other identifiers: SORT OUT XII DAPT Duration2024-515236-69-00
• Study Type: interventional
• Target: 3,150
• Locations: 1 country
• Sites: 3

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)

Conditions

Acute Coronary Syndrome

Keywords

Drug-eluting stent; Dual antiplatelet treatment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Number of patients with clinically relevant bleeding

  1 year

• Number of patients with all-cause death

  1 year

• Number of patients with cardiac death

  1 year

• Number of patients with myocardial infarction

  1 year

• Number of patients with definite stent thrombosis

  1 year

Study Arms (2)

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

Interventions

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

Short duration of DAPT

Conventional duration of aspirin and prasugrel DRUG

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

Conventional duration of DAPT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (3)

Aalborg University Hospital

Aalborg, 9000, Denmark

NOT YET RECRUITING

Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

Odense University Hospital

Odense, 5000, Denmark

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Prasugrel Hydrochloride

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Lisette O Jensen, MD

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

• Evald H Christiansen, MD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

• Ashkan Eftekhari, MD

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisette O Jensen, MD

CONTACT

+4565412690; lisette.okkels.jensen@rsyd.dk

Evald H Christiansen, MD

CONTACT

+4578450000; evald.christiansen@rm.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: December 5, 2024
• Study Start: November 16, 2024
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

DK (3)