Ticagrelor in Human Endotoxemia Response to Human Endotoxemia

Status Completed

Clinical Trial 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 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Endotoxemia

Clinical Trial Details

NCT number	NCT02612480
Study type	Interventional
Source	Radboud University
Contact
Status	Completed
Phase	N/A
Start date	October 2015
Completion date	December 2015

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04117802` - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome	N/A
Completed	`NCT02922673` - The Effects of Acetylsalicylic Acid on Immunoparalysis Following Human Endotoxemia	N/A
Completed	`NCT01766414` - In Vivo Effects of C1-esterase Inhibitor on the Innate Immune Response During Human Endotoxemia - VECTOR II	Phase 3
Completed	`NCT04130321` - Demonstration of the Prebiotic-like Effects of Camu-camu Consumption Against Obesity-related Disorders in Humans	N/A
Completed	`NCT01474629` - Probiotic Sport Study	N/A
Completed	`NCT00246714` - Pathophysiology and Clinical Relevance of Endotoxin Tolerance in Humans	Phase 1
Recruiting	`NCT06147440` - Different Dietary Patterns	N/A
Recruiting	`NCT03901807` - Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Endotoxemic Septic Shock in a Randomized, Open-Label Study	N/A
Completed	`NCT03754504` - Effects of Cranberry Powder Supplements on Gut Microbiota Diversity and Metabolic Syndrome	N/A
Completed	`NCT03800277` - Effect of Cranberry and Agaves Extract on Microbiota and Intestinal Health	N/A
Completed	`NCT00785018` - In Vivo Effects of C1-esterase Inhibitor on the Innate Immune Response During Human Endotoxemia	N/A
Recruiting	`NCT00413348` - Type 2 Diabetes and the Effect of Probiotics	N/A
Recruiting	`NCT00413465` - Study of Renal Blood Flow During Human Endotoxemia	N/A
Completed	`NCT00412906` - Study of Gene Activity in Fat and Muscle in Diabetics and Healthy Controls	N/A
Completed	`NCT05752968` - Elevated Levels of Antibodies to Endotoxin Core in Hemodialysis Patients With Peripheral Artery Disease
Completed	`NCT01374711` - The Effects of Immunostimulation With GM-CSF or IFN-y on Immunoparalysis Following Human Endotoxemia	N/A
Completed	`NCT00916448` - The Effects of Atazanavir-induced Hyperbilirubinemia During Human Endotoxemia	N/A
Completed	`NCT00332267` - Cerebral Blood Flow and Metabolism During Hypoxia and Endotoxemia	N/A
Completed	`NCT03482284` - Effect of Monosaccharides on Intestinal Barrier Function	N/A
Completed	`NCT03972878` - Foodprint 1.0: Physiological Acute Responses After Consumption of Confectionary Products	N/A