Pneumonia Clinical Trial
Official title:
XANTHIPPE: Examining the Effect of Ticagrelor on Platelet Activation, Platelet-Leukocyte Aggregates, and Acute Lung Injury in Pneumonia
The hypothesis to be tested is that ticagrelor (Brilinta™) will reduce platelet activation and markers of inflammation in patients with pneumonia.
While it is well established that platelets are integral to hemostasis, more recent evidence
points to an important role for platelets in inflammation and immunity. Platelet activation
and sequestration in pulmonary tissue is a key feature in inflammatory or infectious states
such as sepsis and acute respiratory distress syndrome (ARDS). Platelets may mediate acute
lung injury (ALI) by recruiting neutrophils, triggering neutrophil extracellular DNA nets,
and releasing granule contents and microparticles. Anti-platelet therapy in this setting may
prevent platelet activation, platelet - leukocyte aggregate formation, and inflammation.
The objective of this pilot study is to determine if ticagrelor therapy in individuals with
pneumonia reduces markers of platelet activation, platelet-leukocyte aggregates,
inflammation, acute lung injury, and lung mechanics. Because the benefit of anti-platelet
therapy may the greatest in patients with more significant lung injury, the investigators
will enroll patients with community-acquired pneumonia (CAP) requiring hospitalization or
patients with hospital acquired pneumonia (HAP) within 48 hours of diagnosis. On study day 1,
subjects will be randomized to receive ticagrelor (180 mg load and 90 mg BID) or placebo.
Study medication (ticagrelor or placebo) will be administered twice daily on days 2 - 7 or
until hospital discharge, if sooner than 7 days. Blood will be collected and assays performed
on day 1 prior to study medication administration (baseline), day 2, 3, 7, day of discharge
(if before 7 days), and 30 days for analysis of platelet count, markers of platelet
activation, platelet - leukocyte interactions, biomarkers of inflammation, and measurements
of lung mechanics.
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