Study to see if platelet transfusion stop or lessen the effect of the drug on platelets
Study identifier:D5130C00079
ClinicalTrials.gov identifier:NCT01744288
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A open label, randomized, crossover and potential parallel, single dose study of ticagrelor 180 mg and acetylsalicylic acid (ASA) in healthy volunteers followed by autologous in vivo platelet transfusion to determine the effects of platelet supplementation on the reversibility of platelet inhibition
Medical condition
Inhibition on Platelet aggregation
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Ticagrelor, Clopidogrel, ASA
Sex
All
Actual Enrollment
258
Study type
Interventional
Age
18 Years - 50 Years
Date
Study Start Date: 01 Dec 2012
Primary Completion Date: 01 Apr 2014
Study Completion Date: 01 Apr 2014
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Oct 2016 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Ticagrelor with Platelet transfusion | Drug: Ticagrelor Oral single loading dose 180ng Drug: ASA 81mg once daily from day -2 up to platelet transfusion |
| Experimental: 2 Ticagrelor without Platelet transfusion | Drug: Ticagrelor Oral single loading dose 180ng Drug: ASA 81mg once daily from day -2 up to platelet transfusion |
| Active Comparator: 3 Clopidogrel with Platelet transfusion | Drug: Clopidogrel Oral single loading dose 600mg Drug: ASA 81mg once daily from day -2 up to platelet transfusion |
| Active Comparator: 4 Clopidogrel without Platelet transfusion | Drug: Clopidogrel Oral single loading dose 600mg Drug: ASA 81mg once daily from day -2 up to platelet transfusion |
Contacts
Investigators
Principal Investigator
Glenn Carlson
AstraZeneca Wilmington US
