Acute coronary syndrome
Conditions
Interventions
Trade Name: Brilique 90 mg film coated tablets
Product Name: Ticagrelor / brilique
Pharmaceutical Form: Coated tablet
Trade Name: Clopidogrel
Product Name: Clopidogrel
Product Code: EU/1/08/465/001
P
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible subjects will be those older than 18 years old, who experienced an ACS (including STEMI or NSTEMI) at least 30 days before, with on going treatment for at least 30 days with dual anti-platelet therapy consisting of aspirin, at doses of 75-160 mg daily and one commercially available P2Y12 oral inhibitor, including ticagrelor, clopidogrel or prasugrel at on-label maintenance regimen who remained free from bleeding (defined as BARC type 2 or greater) or ischemic recurrences and sign informed consent to this study. 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 50
Exclusion criteria
Exclusion criteria: Administration of fibrinolytics or glycoprotein IIb/IIIa inhibitors in the previous 30 days, major surgery within 30 days or any planned surgical intervention, active bleeding or previous clinical relevant bleeding or stroke in the last 6 months, previous intracranial bleeding, thrombocytopenia, oral anticoagulant therapy, vasculitis or any know immunological disorder, severe hepatic failure, uncontrolled hypertension (systolic or diastolic arterial pressure >180 mmHg or 120, respectively, despite medical therapy), known intolerance to aspirin or to clopidogrel or prasugrel or ticagrelor, limited life expectancy, e.g. neoplasms, others, inability to obtain informed consent, pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether Ticagrelor, at steady state, is associated to an improved endothelial function as compared to clopidogrel or prasugrel;Secondary Objective: Not applicable;Primary end point(s): The reactive hyperemia index (RHI) at treatment steady state, assessed with endopath system (Endopath; Itamar Medical Ltd., Cesarea, Israel) assessed 1-2 hour(s) after maintenance drug intake.;Timepoint(s) of evaluation of this end point: 3 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The reactive hyperemia index (RHI) 1-2 hour(s) after the oral P2Y12 inhibitor loading dose assessed with endopath system (Endopath; Itamar Medical Ltd., Cesarea, Israel) as well other plasma or urine markers of endothelial function [Asymmetrical dimethylarginine (ADMA), micro-albuminuria, von willebrand factor antigen, C-reactive protein, soluble fms-like tyrosine kinase-1 (sFLT-1), intercellular cell adhesion molecule-1 (ICAM-1), and vascular cell adhesion molecule-1 (VCAM-1)] after drug loading dose and at treatment steady state;Timepoint(s) of evaluation of this end point: 3 month | — |
Countries
Italy, Netherlands, Spain
Contacts
Public ContactM. Lenzen
Erasmus MC
Outcome results
None listed