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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-005550-28-NL

Enrollment

3090

Registered

2022-02-02

Start date

2022-04-14

Completion date

Unknown

Last updated

2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-ST-segment elevation acute coronary syndrome

Interventions

Trade Name: Acetylsalicylic acid Product Name: Acetylsalicylic acid Product Code: Acetylsalicylic acid Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients aged 18 years or older are eligible for inclusion if all of the following criteria are met: - Clinical diagnosis of NSTE-ACS (i.e. NSTEMI or unstable angina) - Successful PCI (according to the treating physician) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1545 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 1545

Exclusion criteria

Exclusion criteria: Patients who meets any of the following criteria will be excluded from participation: - 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

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objectives of this study are to test the following hypotheses: - Completely omitting aspirin is superior to standard DAPT in terms of major or minor bleeding - Completely omitting aspirin is non-inferior to standard DAPT in terms of ischemic events ;Secondary Objective: The secondary objectives of this study are to test the following hypotheses: - Completely omitting aspirin does not differ from standard DAPT in terms of net clinical adverse events - Completely omitting aspirin does not differ from standard DAPT in terms of definite or probable stent thrombosis - Completely omitting aspirin does not differ from standard DAPT in terms of repeat revascularization - Completely omitting aspirin is superior to standard DAPT in terms of major or minor bleeding in prespecified subgroups (see Chapter 8.2.1) - Completely omitting aspirin is non-inferior to standard DAPT in terms of ischemic events in prespecified subgroups (see Chapter 8.2.1) - Completely omitting aspirin improves the quality of life compared to standard DAPT - Completely omitting aspirin is costs-effective as compared to standard DAPT ;Primary end point(s): The primary bleeding endpoint at 12 months is: - Major or minor bleeding defined as Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding The primary ischemic endpoint at 12 months is the composite of: - All-cause mortality - Myocardial infarction (according to the 4th universal definition of MI) - Stroke ;Timepoint(s) of evaluation of this end point: 12 months	—

Measure

Time frame

Main Objective: The primary objectives of this study are to test the following hypotheses: - Completely omitting aspirin is superior to standard DAPT in terms of major or minor bleeding - Completely omitting aspirin is non-inferior to standard DAPT in terms of ischemic events ;Secondary Objective: The secondary objectives of this study are to test the following hypotheses: - Completely omitting aspirin does not differ from standard DAPT in terms of net clinical adverse events - Completely omitting aspirin does not differ from standard DAPT in terms of definite or probable stent thrombosis - Completely omitting aspirin does not differ from standard DAPT in terms of repeat revascularization - Completely omitting aspirin is superior to standard DAPT in terms of major or minor bleeding in prespecified subgroups (see Chapter 8.2.1) - Completely omitting aspirin is non-inferior to standard DAPT in terms of ischemic events in prespecified subgroups (see Chapter 8.2.1) - Completely omitting aspirin improves the quality of life compared to standard DAPT - Completely omitting aspirin is costs-effective as compared to standard DAPT ;Primary end point(s): The primary bleeding endpoint at 12 months is: - Major or minor bleeding defined as Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding The primary ischemic endpoint at 12 months is the composite of: - All-cause mortality - Myocardial infarction (according to the 4th universal definition of MI) - Stroke ;Timepoint(s) of evaluation of this end point: 12 months

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Secondary

Measure	Time frame
Secondary end point(s): The secondary endpoints are: - Primary bleeding and ischemic endpoints at 1, 3 and 6 month(s) - Individual components of the primary endpoints at 1, 3, 6 and 12 month(s) - Net adverse clinical events at 1, 3, 6 and 12 month(s) defined as the composite of all-cause mortality, myocardial infarction (according to the 4th universal definition of MI), stroke and major bleeding defined as BARC type 3 or 5 bleeding - Academic Research Consortium (ARC) defined definite or probable stent thrombosis at 1, 3, 6 and 12 month(s) - Repeat revascularization at 1, 3, 6 and 12 month(s) - Periprocedural medication during repeat revascularization - Modifications to aspirin or P2Y12-inhibitor regimen at 1, 3, 6 and 12 month(s) The cost-effectiveness endpoints are: - Health-related quality of life (QoL) based on the EQ-5D-5L questionnaire at baseline, 1, 3, 6 and 12 month(s) - Resource utilization based on iMTA Medical Consumption Questionnaire (iMCQ) and iMTA Productivity Cost Questionnaire (iPCQ) at 3, 6 and 12 months ;Timepoint(s) of evaluation of this end point: 12 months	—

Measure

Time frame

Secondary end point(s): The secondary endpoints are: - Primary bleeding and ischemic endpoints at 1, 3 and 6 month(s) - Individual components of the primary endpoints at 1, 3, 6 and 12 month(s) - Net adverse clinical events at 1, 3, 6 and 12 month(s) defined as the composite of all-cause mortality, myocardial infarction (according to the 4th universal definition of MI), stroke and major bleeding defined as BARC type 3 or 5 bleeding - Academic Research Consortium (ARC) defined definite or probable stent thrombosis at 1, 3, 6 and 12 month(s) - Repeat revascularization at 1, 3, 6 and 12 month(s) - Periprocedural medication during repeat revascularization - Modifications to aspirin or P2Y12-inhibitor regimen at 1, 3, 6 and 12 month(s) The cost-effectiveness endpoints are: - Health-related quality of life (QoL) based on the EQ-5D-5L questionnaire at baseline, 1, 3, 6 and 12 month(s) - Resource utilization based on iMTA Medical Consumption Questionnaire (iMCQ) and iMTA Productivity Cost Questionnaire (iPCQ) at 3, 6 and 12 months ;Timepoint(s) of evaluation of this end point: 12 months

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Countries

Netherlands

Contacts

Public ContactArts-onderzoeker

Amsterdam UMC

+310205662857

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026