Ignite Creation Date:
2024-05-06 @ 1:43 AM
Last Modification Date:
2024-10-26 @ 11:08 AM
Study NCT ID:
NCT01883869
Status:
COMPLETED
Last Update Posted:
2018-09-13
First Post:
2013-05-01
Brief Title:
Targeting Platelet-Leukocyte Aggregates in Pneumonia With Ticagrelor
Sponsor:
University of Kentucky
Organization:
University of Kentucky
Study Overview
Official Title:
XANTHIPPE Examining the Effect of Ticagrelor on Platelet Activation Platelet-Leukocyte Aggregates and Acute Lung Injury in Pneumonia
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
XANTHIPPE
Brief Summary:
The hypothesis to be tested is that ticagrelor Brilinta will reduce platelet activation and markers of inflammation in patients with pneumonia
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None