Ignite Creation Date:
2024-05-06 @ 7:52 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02612480
Status:
COMPLETED
Last Update Posted:
2015-12-15
First Post:
2015-11-03
Brief Title:
Ticagrelor in Human Endotoxemia Response to Human Endotoxemia
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
The Effect of Ticagrelor on the Inflammatory Response to Human Endotoxemia
Status:
COMPLETED
Status Verified Date:
2015-12
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:
None
Brief Summary:
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 parametersendpoints
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
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 parametersendpoints
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NL5192309114 | OTHER | CCMO | None |
| 2014-005537-30 | EUDRACT_NUMBER | None | None |