Ignite Creation Date:
2024-05-06 @ 2:47 AM
Last Modification Date:
2024-10-26 @ 11:23 AM
Study NCT ID:
NCT02120092
Status:
COMPLETED
Last Update Posted:
2014-04-22
First Post:
2014-04-17
Brief Title:
The Effect of Clopidogrel and Ticagrelor With and Without Acetylsalicylic Acid ASA on Hemostatic System Activation at the Site of Plug Formation in Vivo in Man
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
The Effect of Clopidogrel and Ticagrelor With and Without Acetylsalicylic Acid ASA on Hemostatic System Activation at the Site of Plug Formation in Vivo in Man
Status:
COMPLETED
Status Verified Date:
2014-04
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:
Background Coronary heart disease is the most common cause of death in industrialized countries Revascularisation by percutaneous coronary angioplasty or thrombolysis is the main principle for treatment of the acute coronary syndrome To inhibit platelet activity patients are routinely given acetylsalicylic acid ASA and clopidogrel a second-generation thienopyridine Recently ticagrelor a novel cyclopentyl-triazolo-pyrimidine with several pharmacological advantages has demonstrated greater efficacy but a higher bleeding risk than clopidogrel Coronary thrombus formation is a complex process and the antithrombotic mechanisms of platelet function inhibitors are incompletely understood Studies in venous blood or in vitro do not truly reflect the in vivo circumstances as they often do not take into account flow conditions or the interaction between endothelium blood cells and coagulation factors Results from animal models may not be relevant for the prothrombotic mechanisms in humans We have developed a technique that allows investigating hemostatic system activation directly at the site of thrombus formation in vivo in humans
Aim to compare the inhibitory effects of clopidogrel and ticagrelor with and without concomitant ASA on hemostatic system activation under circumstances close to the in vivo situation
Design patients and interventions prospective randomized double-blind placebo controlled parallel-group study with a 2x2 factorial design including 112 healthy volunteers who will be randomised to 4 treatment arms ticagrelor or clopidogrel placebo ticagrelor or clopidogrel ASA
Outcome variables Indicators of platelet and coagulation activation ß-thromboglobulin and thromboxane B2 as well as prothrombin fragment F12 and D-Dimer respectively will be measured before and at several time points during a 8 day period in venous blood and in blood emerging from a standardized injury of the microvasculature to determine bleeding time shed blood
Statistical considerations Sample size calculation is based on the percent change in the main outcome variable β-TG in shed blood from baseline to 2 hours after treatment start Statistical analysis is based on the full analysis set including all randomized subjects who received at least the starting dose of the study medication and for whom blood collections at baseline and at 2 hours after treatment start have been performed
Aim to compare the inhibitory effects of clopidogrel and ticagrelor with and without concomitant ASA on hemostatic system activation under circumstances close to the in vivo situation
Design patients and interventions prospective randomized double-blind placebo controlled parallel-group study with a 2x2 factorial design including 112 healthy volunteers who will be randomised to 4 treatment arms ticagrelor or clopidogrel placebo ticagrelor or clopidogrel ASA
Outcome variables Indicators of platelet and coagulation activation ß-thromboglobulin and thromboxane B2 as well as prothrombin fragment F12 and D-Dimer respectively will be measured before and at several time points during a 8 day period in venous blood and in blood emerging from a standardized injury of the microvasculature to determine bleeding time shed blood
Statistical considerations Sample size calculation is based on the percent change in the main outcome variable β-TG in shed blood from baseline to 2 hours after treatment start Statistical analysis is based on the full analysis set including all randomized subjects who received at least the starting dose of the study medication and for whom blood collections at baseline and at 2 hours after treatment start have been performed
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