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

Phase 1

• Conditions: non-ST-segment elevation acute coronary syndrome; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2021-005550-28-NL
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-02
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 3090

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified