Coronary Artery Disease (with an indication for coronary angiography) MedDRA version: 14.1 Level: PT Classification code 10011078 Term: Coronary artery disease System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: Brilique
Pharmaceutical Form: Tablet
INN or Proposed INN: ticagrelor
CAS Number: 274693-27-5
Other descriptive name: TICAGRE
Sponsors
Hellenic Cardiovascular Research Society
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Provision of informed consent prior to any study specific procedures. -?ale and female subjects > 18 and =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. Subjects who had ACS within 12 months of screening. 2. Previous stent implantation with dual antiplatelet therapy within 12 months of screening. 3. Subjects being treated with anti-platelet medications other than aspirin prior to diagnostic catheterization including glycoprotein IIb/IIIa inhibitors. 4. Subjects with NYHA class III or IV heart failure or known left ventricular ejection fraction 1.5 within 1 week of study entry. 10. Poorly controlled blood pressure (>160/100 mmHg). 11. Known platelet count of <100,000/mm3 within 1 week of study entry. 12. Known anemia (hemoglobin [Hb] <10 gr/dL) within 1 week of study entry. 13. Subjects receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors that cannot be discontinued for the duration of the study. 14. Severe kidney disease (GFR<30 ml/min/1.73m2). 15. Hepatic insufficiency defined as liver cirrhosis, AST/ALT/Alkaline Phosphatase greater than 3 times the upper limit of normal or hyperbilirubinemia defined as peak total serum bilirubin greater than 2 times the upper limit of normal (ULN). 16. Any indication (atrial fibrillation, mitral stenosis or prosthetic heart valve, pulmonary embolism (PE), deep vein thrombosis (DVT)) for anticoagulation treatment during study period. 17. Asthma or chronic obstructive pulmonary disease requiring brochodilating agents. 18. Concomitant use of potent Cytochrome P450 3A4 (CYP3A4) inhibitors (atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole) or inducers (carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampin, and rifapentine). 19. Concomitant use of drugs that are metabolized through CYP2C19 (omeprazole and esomeprazole, fluvoxamine, fluoxetine, moclobemide, voriconazole, fluconazole, ticlopidine, ciprofloxacin, cimetidine, carbamazepine, oxcarbazepine and chloramphenicol). 20. History of uric acid nephropathy and high levels of uric acid within 1 week of study entry. 21. Increased risk of bradycardic events (e.g. known sick sinus syndrome or third degree AV block or previous documented syncope suspected to be due to bradycardia unless treated with a pacemaker). 22. Known neoplastic or autoimmune disease or any concomitant medical illness that in the opinion of the Investigator may interfere with or prevent completion in this study. 23. Contraindication to clopidogrel, ASA, or ticagrelor. 24. A history of alcohol and/or substance abuse that could interfere with conduct of the trial. 25. Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ?o compare ticagrelor versus clopidogrel regarding their effect on arterial stiffness as assessed by PWV, at 3 hours after the loading dose of each regimen, in eligible subjects with CAD.; Secondary Objective: -To compare ticagrelor versus clopidogrel treatment regarding their effect on arterial stiffness as assessed by PWV, at 24 hours after the loading dose of each regimen, in the acute period populations; -To compare ticagrelor versus clopidogrel treatment regarding their effect on arterial stiffness as assessed by PWV, at 1 month after coronary stent placement, in the chronic period populations; -To compare ticagrelor versus clopidogrel treatment regarding their effect on central blood pressures and augmentation index in both the acute and the chronic period populations; -To compare ticagrelor versus clopidogrel treatment regarding their effect on endothelial function assessed by brachial artery ultrasound and circulating markers of endothelial dysfunction. ;Primary end point(s): The primary outcome is the between treatment difference in the mean change in the cfPWV from baseline (0 hours) at 3 hours after the loading dose of each regimen, in ticagrelor and clopidogrel acute period populations.;Timepoint(s) of evaluation of this end point: ?t 3 hours after the loading dose of each regimen, in ticagrelor and clopidogrel acute period populations. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The between treatment difference in the mean change in the cfPWV from baseline (0 hours) at 24 hours after the loading dose of each regimen, in the acute period populations; • The between treatment difference in the mean change in the cfPWV from baseline (0 hours) at 1 month after coronary stent placement, in the chronic period populations; • The between treatment difference in the mean change in the Central Aortic Systolic Blood Pressure (CASBP), Central Aortic Diastolic Blood Pressure (CASDP) and cPP from baseline (0 hours) at 3 and 24 hours after the loading dose of each regimen, in the acute period populations; • The between treatment difference in the mean change in the Central Aortic Systolic Blood Pressure (CASBP), Central Aortic Diastolic Blood Pressure (CASDP) and cPP from baseline at 1 month (30 days) after coronary stent placement, in the chronic period populations; • The between treatment difference in the mean change in the heart-rate-corrected AIx, from baseline (0 hours) at 3 and 24 hours after the loading dose of each regimen, in the acute period populations; • The between treatment difference in the mean change in the heart-rate-corrected AIx from baseline (0 hours) at 1 month (30 days) after coronary stent placement, in the chronic period populations; • The between treatment difference in the mean change in the brachial artery FMD from baseline (0 hours) at 3 and 24 hours after the loading dose of each regimen, in the acute period populations; • The between treatment difference in the mean change in the brachial artery FMD from baseline at 1 month (30 days) after coronary stent placement, in the chronic period populations; • The between treatment difference in the mean change in the circulating endothelial markers (plasma levels of endothelin-1, TNF-a and von-Willebrand factor) from baseline (0 ho | — |
Countries
Greece
Contacts
Public ContactCharalambos Vlachopoulos
1st Department of Cardiology, University of Athens Medical School, Hippokration Hospital
Outcome results
None listed