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

Phase 4

Recruiting

• Conditions: Non ST Segment Elevation Acute Coronary Syndrome
• Interventions: Drug: No aspirin; Drug: Aspirin

• Registration Number: NCT05125276
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-08
• Study First Submitted QC: 2021-11-08
• Study First Posted: 2021-11-18
• Study Start: 2022-05-13
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-19
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3090

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional arm	No aspirin	No aspirin
Control arm	Aspirin	Aspirin (75-100 mg once daily)

Primary Outcome Measures

Name	Time	Method
Bleeding endpoint	12 months	The primary bleeding endpoint at 12 months is major or minor bleeding defined as BARC type 2, 3 or 5 bleeding
Ischemic endpoint	12 months	The primary ischemic endpoint at 12 months is the composite of all-cause mortality, myocardial infarction and stroke

Trial Locations

Locations (2)

Amsterdam UMC, location VUmc; 🇳🇱 Amsterdam, Netherlands

Amsterdam UMC, location AMC; 🇳🇱 Amsterdam, Netherlands