Less Bleeding by Omitting Aspirin in Non-ST-segment Elevation Acute Coronary Syndrome Patients

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

3090 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-13

Study Completion Date

2025-07-31

Brief Summary

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Rationale: Dual antiplatelet therapy, consisting of aspirin and a P2Y12-inhibitor, reduces the risk of stent thrombosis, myocardial infarction and stroke after coronary stent implantation. Inevitably, it is also associated with a higher risk of (major) bleeding. Given the advances in stent properties, stenting implantation technique and pharmacology, it may be possible to treat patients with a single antiplatelet strategy by completely omitting aspirin.

Objective: This study will assess whether omitting aspirin reduces the rate of major or minor bleeding while remaining non-inferior to the current standard of care with regards to ischemic events in patients with non-ST segment elevation acute coronary syndrome.

Study design: Open-label, multicentre randomized controlled trial.

Study population: Adult patients presenting with non-ST segment elevation acute coronary syndrome undergoing percutaneous coronary intervention.

Intervention: In the intervention group aspirin will be completely omitted from the antiplatelet regimen in the 12 months following PCI.

Main study endpoints: The primary bleeding endpoint is major or minor bleeding defined as Bleeding Academic Research Consortium type 2, 3 or 5 bleeding at 12 months. The primary ischemic endpoint is ischemic events defined as the composite of all-cause death, myocardial infarction and stroke at 12 months.

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Detailed Description

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Conditions

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Non ST Segment Elevation 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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Interventional arm

No aspirin

Group Type EXPERIMENTAL

No aspirin

Intervention Type DRUG

No aspirin

Control arm

Aspirin (75-100 mg once daily)

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

75-100 mg once daily

Interventions

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No aspirin

Intervention Type DRUG

Aspirin

75-100 mg once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of NSTE-ACS (i.e. NSTEMI or unstable angina)
* Successful PCI (according to the treating physician)

Exclusion Criteria

* Known allergy or contraindication for aspirin or all commercially available P2Y12-inhibitors (i.e. ticagrelor, prasugrel and clopidogrel)
* Concurrent use of oral anticoagulants (e.g. because of atrial fibrillation)
* Ongoing indication for DAPT at admission (e.g. due to recent PCI or ACS)
* Planned surgical intervention within 12 months of PCI
* Pregnant or breastfeeding women at time of enrolment
* Participation in another trial with an investigational drug or device

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No