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

Non ST Segment Elevation Acute Coronary Syndrome Clinical Trial

— LEGACY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05125276
• Other study ID #: NL79129.018.21
• Status: Recruiting
• Phase: Phase 4
• Start date: May 13, 2022
• Est. completion date: July 2025

Study information

• Verified date: July 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3090
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Non ST Segment Elevation Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• No aspirin
No aspirin
• Aspirin
75-100 mg once daily

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC, location AMC	Amsterdam
Netherlands	Amsterdam UMC, location VUmc	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding endpoint	The primary bleeding endpoint at 12 months is major or minor bleeding defined as BARC type 2, 3 or 5 bleeding	12 months
Primary	Ischemic endpoint	The primary ischemic endpoint at 12 months is the composite of all-cause mortality, myocardial infarction and stroke	12 months