Study to see if platelet transfusion stop or lessen the effect of the drug on platelets
A open label, randomized, crossover and potential parallel, single dose study of ticagrelor 180 mg and acetylsalicylic acid (ASA) in healthy volunteers followed by autologous in vivo platelet transfusion to determine the effects of platelet supplementation on the reversibility of platelet inhibition
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
258
Oral single loading dose 180ng
Oral single loading dose 600mg
81mg once daily from day -2 up to platelet transfusion
Research Site
Overland Park, Kansas, United States
Pharmacodynamics in terms of percent of inhibition of adenosine phosphatase (ADP)-induced platelet aggregation assessed by light transmission aggregometry (LTA) after loading dose of Ticagrelor
Time frame: Predose, 0h, 2h,6h,12h,24h,36h,48h,60h,72h,84h and 96h
Pharmacodynamics in terms of platelet reactivity as measured by P2Y12 Reaction Units (PRU) using VerifyNow™ after loading dose of Ticagrelor
Time frame: Predose, 0h, 2h,6h,12h,24h,36h,48h,60h,72h,84h and 96h
Pharmacodynamics in terms of platelet reactivity as measured by P2Y12 Reaction Units (PRU) using VerifyNow™ after loading dose of Clopidogrel
Time frame: Predose, 0h, 2h,6h,12h,24h,36h,48h,60h,72h,84h and 96h
Pharmacodynamics in terms of percent of inhibition of adenosine phosphatase (ADP)-induced platelet aggregation assessed by light transmission aggregometry (LTA) after loading dose of Clopidogrel
Time frame: Predose, 0h, 2h,6h,12h,24h,36h,48h,60h,72h,84h and 96h
Safety profile in terms of adverse events, blood pressure, pulse, temperature, ECG (Electrocardiogram), physical examination, and safety laboratory variables
Time frame: up to 9 weeks
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