The primary objective of the study is to compare the platelet inhibition of ticagrelor versus clopidogrel in post-MI patients in terms of platelet reactivity at the end of the 2 study periods (pre-crossover and post crossover). MedDRA version: 19.0 Level: SOC Classification code 10007541 Term: Cardiac disorders System Organ Class: 10007541 - Cardiac disorders MedDRA version: 19.0 Level: PT Classification code 10007649 Term: Cardiovascular disorder System Organ Class: 10007541 - Cardiac disord
Conditions
Interventions
Trade Name: Brilique
Product Name: Brilique(TM)
Pharmaceutical Form: Film-coated tablet
Trade Name: Clopidogrel Zentiva
Product Name: Clopidogrel Zentiva
Pharmaceutical Form: Film-coated tablet
Sponsors
Special Account for Research Funds-University of Patras
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Provision of informed consent prior to any study specific procedures 2.Post-menopausal female (defined as absence of any vaginal bleeding for a year) or male aged >50 years 3.A spontaneous MI (ST or Non ST segment elevation) 1 to 3 years before enrolment. In addition, at least one of the following high-risk features: age of 65 years or older, diabetes mellitus requiring medication, a second prior spontaneous MI, multivessel coronary artery disease, or non-end stage renal disease (estimated creatinine clearance of =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1.Planned use of a P2Y12 receptor antagonist, dipyridamole, cilostazol, or anticoagulant therapy during the study period; 2.Known allergy, intolerance, hypersensitivity to ticagrelor or clopidogrel or any excipients, 3.Active pathological bleeding, severe hepatic impairment, a bleeding disorder or a history of an ischemic stroke or intracranial bleeding, a central nervous system tumor, or an intracranial vascular abnormality; 4.Gastrointestinal bleeding within the previous 6 months or major surgery within the previous 30 days; 5.Concomitant use of potent Cytochrome P450 3A4 (CYP3A4) inhibitors (atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole, grapefruit juice over 1 litre daily), CYP3A substrates with narrow therapeutic indices (cyclosporine, quinidine), or inducers (carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampin, and rifapentine). 6.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). 7.Inability to adhere to the follow-up requirements or any other reason or condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated. The following restrictions should also be applied to the subjects participating in this study: 1. Male subjects should be willing to use barrier methods of contraception during the study and for time period equal to 5 half-lives of the assigned investigational agent after end of study, unless their partners are post-menopausal, surgically sterile or are using accepted contraceptive methods. 2. Subjects should not receive treatment during the study with any of the disallowed medications outlined in the Exclusion Criteria (Section 4.2; Exclusion Criteria).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to compare the platelet inhibition of ticagrelor versus clopidogrel in post-MI patients in terms of platelet reactivity at the end of the 2 study periods (pre-crossover and post crossover).;Secondary Objective: To compare the platelet inhibition of ticagrelor versus clopidogrel in terms of VerifyNow P2Y12 assay % inhibition, using the TRAP-induced (BASE channel) response and High platelet reactivity rate (PRU >208) at the end of the 2 study periods (pre-crossover and post crossover). ;Primary end point(s): The primary endpoint is the platelet reactivity measured in P2Y12 reaction units (PRU) at the end of the 2 study periods (pre-crossover and post-crossover).;Timepoint(s) of evaluation of this end point: Patients will undergo platelet reactivity assessment with the VerifyNow assay in PRU at visit 2, 3 and 4. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •High platelet reactivity rate (defined as >208 PRU) at the end of the 2 study periods •VerifyNow P2Y12 assay % inhibition, using the TRAP-induced (BASE channel) response at the end of the 2 study periods •The number and proportion of subjects experience any adverse event. •The total number of bleeding events [defined by the Bleeding Academic Research Consortium (BARC) criteria] and the incidence rate of bleeding for ticagrelor compared to clopidogrel throughout the study. ;Timepoint(s) of evaluation of this end point: Between Visit 2 of the First Patient enrolled till the end of the trial ( 32 days after Visit 2 of the Last Patient enrolled in the study) | — |
Countries
Greece
Contacts
Public ContactHead of Clinical Operations
Creative Pharma Services SA
Outcome results
None listed