Endotoxemia Clinical Trial
Official title:
The Effect of Ticagrelor on the Inflammatory Response to Human Endotoxemia
Rationale:
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science
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