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

Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05125276
Collaborator
(none)
3,090
Enrollment
2
Arms
36
Anticipated Duration (Months)

Study Details

Study Description

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 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 net clinical adverse events and 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 planned for 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 parameters/endpoints: The primary net adverse clinical endpoint is defined as the composite of all-cause death, myocardial infarction, stroke and Bleeding Academic Research Consortium type 3 or 5 bleeding at 12 months. 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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
3090 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Less Bleeding by Omitting Aspirin in Non-ST-segment Elevation Acute Coronary
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2025
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

ArmIntervention/Treatment
Experimental: Interventional arm

No aspirin

Drug: No aspirin
No aspirin

Active Comparator: Control arm

Aspirin (75-100 mg once daily)

Drug: Aspirin
75-100 mg once daily

Outcome Measures

Primary Outcome Measures

  1. Net adverse clinical endpoint (NACE) [12 months]

    The primary net adverse clinical endpoint at 12 months is the composite of all-cause mortality, myocardial infarction, stroke and major bleeding defined as Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding

  2. 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

  3. Ischemic endpoint [12 months]

    The primary ischemic endpoint at 12 months is the composite of all-cause mortality, myocardial infarction and stroke

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Adult patients presenting with NSTE-ACS planned for PCI

  • Written informed consent

Exclusion Criteria:
  • Known allergy or contraindication for aspirin or P2Y12-inhibitors

  • Concurrent use of oral anticoagulants (e.g. because of atrial fibrillation)

  • Overwriting indication for DAPT (e.g. recent PCI or ACS)

  • Planned surgical intervention within 12 months of revascularization

  • Pregnant or breastfeeding women at time of enrolment

  • Participation in another trial with an investigational drug or device (i.e. stent)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
J.P.S Henriques, Prof. Dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT05125276
Other Study ID Numbers:
  • NL79129.018.21
First Posted:
Nov 18, 2021
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2021