NCT05125276

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,090

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2022

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 18, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

May 13, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

3.1 years

First QC Date

November 8, 2021

Last Update Submit

July 18, 2023

Conditions

Non ST Segment Elevation Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (2)

  • 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

  • Ischemic endpoint

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

    12 months

Study Arms (2)

Interventional arm

EXPERIMENTAL

No aspirin

Drug: No aspirin

Control arm

ACTIVE COMPARATOR

Aspirin (75-100 mg once daily)

Drug: Aspirin

Interventions

No aspirinDRUG

No aspirin

Interventional arm
AspirinDRUG

75-100 mg once daily

Control arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Amsterdam UMC, location AMC

Amsterdam, Netherlands

RECRUITING

Amsterdam UMC, location VUmc

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Interventions

N-acetyl-S-(alpha-methyl-4-(2-methylpropyl)benzeneacetyl)cysteine 4-(nitrooxy)butyl esterAspirin

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

November 8, 2021

First Posted

November 18, 2021

Study Start

May 13, 2022

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

July 19, 2023

Record last verified: 2023-07

Locations

NL(2)