Acute Coronary Syndrome Clinical Trial
Official title:
Influence of Esomeprazole on Antiplatelet Action of Clopidogrel Associated With Aspirin
The investigators examine the influence of esomeprazole versus famotidine on antiplatelet
action of clopidogrel associated with aspirin. At least 100 consecutive patients suffering
from acute coronary syndrome or undergoing coronary artery stent implantation , who received
aspirin (80 - 160 mg/day) and clopidogrel (300 mg loading dose, followed by 75 mg/day or
75mg/day for at least 7 consecutive days), are randomised to receive either esomeprazole 20
mg daily vs famotidine 40 mg daily in a double blinded manner. Clopidogrel effect was tested
by measuring residual platelet reactivity (RPR) to ADP by VerifyNow P2Y12 assay (Accumetrics
Inc, San Diego, Calif). At baseline, whole blood will be obtained for RPR at least 12 h
after clopidogrel loading dose or at least 7 days of maintaince dose. Immediately obtaining
the baseline blood, patients will be randomized to receive either esomeprazole (20 mg/day)
or famotidine 40 mg/day for 28 days. Double blinding will be performed by encapsulation of
study drugs. RPR will be measured again at the 28th day.
The investigators will compare the % inhibition and the P2Y12 reaction Units (PRU) at the
28-day treatment period in the 2 groups.
n/a
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
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