Ticagrelor in Human Endotoxemia Response to Human Endotoxemia
NCT ID: NCT02612480
Last Updated: 2015-12-15
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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COMPLETED
NA
40 participants
INTERVENTIONAL
2015-10-31
2015-12-31
Brief Summary
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In patients suffering a myocardial infarction the P2Y12 receptor antagonists prasugrel and ticagrelor improve outcome and prognosis compared to clopidogrel. Moreover, ticagrelor lowers mortality from pulmonary infections and sepsis, which cannot solely be explained by its platelet-inhibiting effect. An effect on the inflammatory response in the setting of acute myocardial might underlie this phenomenon and if substantiated support a novel beneficial mechanism of the new the P2Y12 receptor antagonists.
Objective:
To study whether ticagrelor, added to acetylsalicylic acid, modulates the inflammatory response to the administration of lipopolysaccharide (LPS) in humans in vivo, and to compare this effect with the P2Y12 antagonist clopidogrel.
Study design:
Prospective randomized placebo-controlled trial, according to a PROBE design (prospective randomized open blinded-endpoint study).
Study population:
Forty healthy male volunteers aged ≥ 18 and ≤ 35 years. Intervention (if applicable): Participants will be randomized to receive either placebo (twice daily), acetylsalicylic acid (80 mg once daily, after a loading dose of 160 mg) + placebo (once daily), acetylsalicylic acid (80 mg once daily, after a loading dose of 160 mg) + ticagrelor (90 mg twice daily, after a loading dose of 180 mg) or acetylsalicylic acid (80 mg once daily, after a loading dose of 160 mg)+ clopidogrel (75 mg once daily, after a loading dose of 300mg).
Main study parameters/endpoints:
Endpoints: area under the curve of the proinflammatory cytokines TNF-alpha, IL6, IL-10, IL1ra IL-8, IL-1β, MCP-1 MIP-1a, MIP-1b en IFN; peak concentrations of the various cytokines; plasma concentration of HMGP1; platelet-monocyte complex formation and markers of platelet function; plasma concentration of adenosine.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Ticagrelor and acetylsalicylic acid
7 day treatment with ticagrelor 2x90mg after a loading dose of 180 mg and acetylsalicyclic acid 1x80mg after a loading dose of 160 mg.
ticagrelor
7 day treatment of ticagrelor 2dd90mg after a loading dose of 180mg
Acetylsalicylic acid lysinate
7 day treatment of acetylsalicyclic acid 1d80mg after a loading dose of 160mg
Clopidogrel and acetylsalicylic acid
7 day treatment with clopidogrel x75 mg after a loading dose of 300 mg and acetylsalicyclic acid 1x80mg after a loading dose of 160 mg
Clopidogrel
7 day treatment of clopidogrel 1d75mg after a loading dose of 300mg
Acetylsalicylic acid lysinate
7 day treatment of acetylsalicyclic acid 1d80mg after a loading dose of 160mg
Placebo and acetylsalicylic acid
7 day treatment with placebo and acetylsalicyclic acid 1x80mg after a loading dose of 160 mg
Acetylsalicylic acid lysinate
7 day treatment of acetylsalicyclic acid 1d80mg after a loading dose of 160mg
Placebo
7 day treatment with placebo
Placebo
7 day treatment with 2 placebos
Placebo
7 day treatment with placebo
Interventions
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ticagrelor
7 day treatment of ticagrelor 2dd90mg after a loading dose of 180mg
Clopidogrel
7 day treatment of clopidogrel 1d75mg after a loading dose of 300mg
Acetylsalicylic acid lysinate
7 day treatment of acetylsalicyclic acid 1d80mg after a loading dose of 160mg
Placebo
7 day treatment with placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male
* No known current medical/psychiatric diseases
Exclusion Criteria
* History of chronic obstructive pulmonary disease (COPD) or asthma
* History of hemorrhagic diathesis, or any other disorder associated with increased risk of bleeding
* Previous spontaneous vagal collapse
* Use of any medication
* Smoking
* Liver enzyme abnormalities (defined as ALAT and/or ASAT \> twice upper limit of normality)
* Thrombocytopenia (\<150\*109
/ml) or anemia (haemoglobin \< 8.0 mmol/L)
* Any obvious disease associated with immune deficiency
* Febrile illness in the week before the LPS challenge
* Hypersensitivity to ticagrelor or any excipients
* Active pathological bleeding
* History of intracranial haemorrhage
* History of dyspepsia
* quantitative bleeding assessment tool (BAT) score \>3 (see Appendix 1)
* Participation in another drug trial or donation of blood 3 months prior, until 3 months after the planned LPS challenge
* Cardiac conduction abnormalities on the ECG consisting of a 2nd degree atrioventricular block, third degree atrioventricular block or a complex bundle branch block
* Hypertension (defined as RR systolic \> 160 or RR diastolic \> 90)
* Hypotension (defined as RR systolic \< 100 or RR diastolic \< 50)
* Renal impairment (defined as MDRD \< 60 ml/min)
18 Years
35 Years
MALE
Yes
Sponsors
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Radboud University Medical Center
OTHER
Responsible Party
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Peter Pickkers
Prof. Dr. Peter Pickkers
Principal Investigators
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Peter Pickkers, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Niels Riksen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
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Intensive Care Medicine, Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands
Countries
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Other Identifiers
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2014-005537-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NL51923.091.14
Identifier Type: OTHER
Identifier Source: secondary_id
tica-lps
Identifier Type: -
Identifier Source: org_study_id