Optical Coherence Tomography-Guided PCI with Single-Antiplatelet Therapy

Phase 1

• Conditions: non-ST segment elevation acute coronary syndrome; MedDRA version: 20.0Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 20.0Level: LLTClassification code 10071111Term: Non ST segment elevation acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-003437-38-NL
• Lead Sponsor: AMC Medical Research B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-23
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

- Age =18 years
- NSTE-ACS diagnosis in accordance with relevant guidelines
- ‘De novo’ coronary lesion(s) eligible for PCI using new generation drug-eluting stent and requiring
revascularization according to relevant guidelines
- Written informed consent
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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

- Known allergy or contraindication for prasugrel or ticagrelor use
- Concurrent use of oral anticoagulants (e.g. for atrial fibrillation)
- Overwriting indication for DAPT (e.g. recent PCI or ACS)
- Planned surgical intervention within 12 months of planned revascularization
- PCI of left main disease, chronic total occlusion, bifurcation lesion requiring two-stent treatment, saphenous or
arterial graft lesion, severely calcified lesions
- Recent or ongoing treatment with a strong CYP3A4 inhibitor or inducer
- Pregnant or breastfeeding women at time of enrolment
- Participation in another trial with an investigational drug or device (i.e. stent)

Study & Design

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