Optical Coherence Tomography-Guided PCI with Single-Antiplatelet Therapy - OPTICA

AMC Medical Research B.V.0 个研究点目标入组 1 人开始时间: 2020年12月23日最近更新: 2021年6月7日

适应症

试验速览

暂无简介。

•- 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

•- 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)

发起方

AMC Medical Research B.V.