Acute Coronary Syndrome Clinical Trial
Official title:
Efficacy and Safety of Individualized P2Y12 Receptor Antagonists Treatment Based on Agregometry Versus Fixed Dose Regimen in Patients After Acute Myocardial Infarction
The specific goal of this study is to determine whether the individualized approach and adjusting the dosage of the P2Y12 receptor inhibitors will improve the platelet inhibiton and the clinical outcome in patients with an ACS, that were treated with PCI and the aforementioned drugs, but with an increased initial residual platelet activity. It is expected that the patients that have undergone the P2Y12 inhibitor therapy adjustment (according to the platelet reactivity measured by POC devices) will have better clinical outcomes (ie less ischemic events, without a significant increase in bleeding events) than those who did not undergo the therapy adjustment.
In this study we plan to continue our previous research on individualized approach to
platelet aniaggregation therapy in patients with an ACS treated with a PCI. The subjects
included in this study will be adult patients successfully treated in our department for ACS
(unstabile angina pectoris, non-ST segment elevation myocardial infarction and ST segment
elevation myocardal infarction) with a PCI, a coronary stent implantation and the subsequent
dual platelet antiaggregation therapy combining ASA and a P2Y12 receptor inhibitor. The
diagnosis of different types of ACS will be made depending on the clinical presentation, ECG
findings and changes in cardiac biomarker serum levels (troponin T and MB creatinine kinase
isoezyme). Percutaneous coronary revascularization and the dual platelet antiaggregation
therapy are the basis of the modern ACS treatment. Because the newer P2Y12 receptor
inhibitors are not momentarily widely available in Croatia, the initial treatment will
include the combination of ASA and clopidogrel. The exclusion critera are as following:
postinterventional continuous GPIIb/IIIa inhibitor therapy, thrombocytopenia (<150x10E9/L),
signifcant renal failure (creatinine>200 µmol/L), anemia (Htc<30%), hemorrhagic diathesis,
history of recent hemorrhagic or ischemic CVI (within 6 months of admission), recent surgical
procedure (within 6 weeks of admission) and an indication for chronic anticoagulant therapy.
Also patients older than 80 years of age will not be included into this study. The necessary
number of subjects is between 100 and 120.
Aggregometry using the ADP test will be done to all the patients without the exclusion
criteria that were successfully treated wth PCI. The testing will be done within 24 hours of
the intervention in order to determine the pharmacodynamic effect P2Y12 receptor inhibitors
have on platelets and their reactivity. The optimal platelet reactivity (according to the
international consensus) is between 19 and 46 U (49). The patients that will have an
increased residual PR (>46 U) after being given the loading doses of clopidogrel will be
included in this study and randomized into three groups using a computer software (Research
Randomizer). The patients randomized into the first group will be given the newer P2Y12
receptor inhibitor ticagrelor during the 12 months. The second group of patients will be
given ticagrelor initially, and after the first 30 days it will be replaced with clopidogrel,
that will be given for the remaining time period (up to 12 months). Clopidogrel dosing will
be modified according to the results of the aggregometry using the ADP test. The third group
of patients will have the same therapy regiment as the second group, but will be given the
standard doses of clopidogrel regardless of the aggregometry findings. The follow-up period,
during which the dual platelet antiaggregation therapy will be administered, is going to be
12 months for each patient. Within this time-frame, total of ten PR measurements will be
done. The measurements in the first month are scheduled as follows: on the first, second,
third, seventh and thirtieth day after the ACS and the PCI. The following measurements are
scheduled two, three, six, nine and twelve months after the ACS and the PCI.
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