Critical Illness Clinical Trial
Official title:
High "on Treatment" Platelet Reactivity in the Intensive Care Unit
High "on treatment" platelet reactivity is defined as a poor pharmacodynamic response to the
administration of acetylsalicylic acid or clopidogrel. acetylsalicylic acid and clopidogrel
are drugs commonly used to reduce platelet activity and prevent cardiovascular events. High
"on treatment" platelet reactivity is associated with a higher cardiovascular event rate.
Ticagrelor and prasugrel, like clopidogrel both P2Y12 inhibitors are effective in treating
patients with High "on treatment" platelet reactivity to clopidogrel.
Critically ill patients are a unique population with altered pharmacokinetic and
pharmacodynamic properties. Gastrointestinal dysmotility with associated altered resorption
and impaired microvascular function occur frequently in critically ill patients and may lead
to altered resorption of orally administered drugs.
The investigators will test a minimum of 100 patients treated with 100mg acetylsalicylic acid
per os and 100 patients treated with 75mg clopidogrel per os to calculate the prevalence of
high "on treatment" platelet reactivity.
30 patients with high "on treatment" platelet reactivity to acetylsalicylic acid will be
randomized to three new treatment groups. In the first group patients will receive 200mg
acetylsalicylic acid per os, in the second group 100mg acetylsalicylic acid intravenously and
in the third group 81mg chewable acetylsalicylic acid. Each group will contain 10 patients.
Pharmacokinetics and pharmacodynamics will be reassessed to evaluate the new treatment.
36 patients with high "on treatment" platelet reactivity to clopidogrel will be randomized to
receive either an additional loading dose of 600mg clopidogrel (n=24) or to continue normal
treatment as a control group (n=12). Pharmacokinetics and pharmacodynamics will be reassessed
and those patients, who are tested again to have high "on treatment" platelet reactivity in
spite of the additional loading dose, will now be randomized to receive either ticagrelor or
prasugrel. The investigators expect about six patients per group. The twelve patients in the
control group will continue normal treatment (75mg/day) until the end of the study.
Pharmacokinetics and pharmacodynamics of ticagrelor and prasugrel will be assessed. Any
patient, who is tested again with high "on treatment" platelet reactivity in spite of
receiving prasugrel or ticagrelor, will be finally switched to the opposite drug and a final
high "on treatment" platelet reactivity testing will be conducted.
16 patients who are treated with 10mg prasugrel per os will be tested for HTPR and if
positively tested will be switched to 2x90mg ticagrelor per os per day. Platelet reactivity
will be reassessed to test whether switching the medication benefits the patients.
n/a
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