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

NCT ID: NCT06718179

Last Updated: 2025-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

3150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-16

Study Completion Date

2030-12-31

Brief Summary

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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)

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Detailed Description

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Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Short duration of DAPT

Group Type EXPERIMENTAL

Short duration of aspirin and prasugrel

Intervention Type 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 DAPT

Group Type ACTIVE_COMPARATOR

Conventional duration of aspirin and prasugrel

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Conventional duration of aspirin and prasugrel

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisette O Jensen, MD

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Evald H Christiansen, MD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Ashkan Eftekhari, MD

Role: PRINCIPAL_INVESTIGATOR

Aalborg University Hospital

Locations

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Aalborg University Hospital

Aalborg, , Denmark

Site Status NOT_YET_RECRUITING

Aarhus University Hospital

Aarhus, , Denmark

Site Status RECRUITING

Odense University Hospital

Odense, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Lisette O Jensen, MD

Role: CONTACT

[email protected]
+4565412690

Evald H Christiansen, MD

Role: CONTACT

[email protected]
+4578450000

Facility Contacts

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Ashkan Eftekhari, MD

Role: primary

4528973764

Evald Christiansen, MD

Role: primary

[email protected]
4561655176

Lisette Okkels Jensen, MD

Role: primary

[email protected]
4565412690

Other Identifiers

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2024-515236-69-00

Identifier Type: CTIS

Identifier Source: secondary_id

SORT OUT XII DAPT Duration

Identifier Type: -

Identifier Source: org_study_id

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