High "on Treatment" Platelet Reactivity in the Intensive Care Unit
NCT ID: NCT02285751
Last Updated: 2019-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
200 participants
INTERVENTIONAL
2012-11-30
2020-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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200mg acetylsalicylic acid per os
patients with high "on treatment" platelet reactivity to acetylsalicylic acid are randomized to 3 different groups, one group receives 200mg acetylsalicylic acid per os
acetylsalicylic acid
100mg acetylsalicylic acid intravenous
patients with high "on treatment" platelet reactivity to acetylsalicylic acid are randomized to 3 different groups, one group receives 100mg acetylsalicylic acid intravenously.
acetylsalicylic acid
81 mg chewable acetylsalicylic acid
patients with high "on treatment" platelet reactivity to acetylsalicylic acid are randomized to 3 different groups, one group receives 81mg chewable acetylsalicylic acid
acetylsalicylic acid
75mg clopidogrel
control group for patients with high "on treatment" platelet reactivity to clopidogrel patients continue with standard treatment 75mg clopidogrel/day
clopidogrel
60mg prasugrel
Loading dose of prasugrel for patients who remain tested with high "on treatment" platelet reactivity in spite of having received an additional loading dose of 600mg clopidogrel
prasugrel
600mg clopidogrel
additional loading dose for 24 patients tested with high "on treatment" platelet reactivity to clopidogrel
clopidogrel
180mg ticagrelor
Loading dose of ticagrelor for patients who remain tested with high "on treatment" platelet reactivity in spite of having received an additional loading dose of 600mg clopidogrel Loading dose of ticagrelor for patients who remain tested with high "on treatment" platelet reactivity after being treated with 10mg prasugrel daily
ticagrelor
prasugrel 10mg
patients treated with 10mg prasugrel daily
prasugrel
Interventions
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acetylsalicylic acid
clopidogrel
prasugrel
ticagrelor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* admittance to an intensive care unit
Exclusion Criteria
* active bleeding
* known coagulation disorders
* discretion of the physician
* terminal illness (anticipated life expectancy \< 3months; e.g. due to cancer)
* pregnancy
* \<20000 platelets
18 Years
ALL
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Bernd Jilma
Ao. Univ.-Prof. Dr. Bernd Jilma
Principal Investigators
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Bernd Jilma, Ao. Univ.-Prof. Dr. med
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna, Department of Clinical Pharmacology
Locations
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General Hospital
Vienna, , Austria
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2012-002226-76
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
HTPR-ICU
Identifier Type: -
Identifier Source: org_study_id
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