Ignite Creation Date:
2024-05-06 @ 10:06 AM
Last Modification Date:
2024-10-26 @ 12:24 PM
Study NCT ID:
NCT03161678
Status:
COMPLETED
Last Update Posted:
2024-05-06
First Post:
2017-05-18
Brief Title:
CES1 Crossover Trial of Clopidogrel and Ticagrelor
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Impact of Genetic Variation in CES1 on Antiplatelet Therapy
Status:
COMPLETED
Status Verified Date:
2024-05
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:
The purpose of this investigation is to evaluate when genetic variation in the carboxylesterase 1 CES1 gene influences antiplatelet therapy response as assessed by ex vivo platelet aggregometry in healthy participants treated with clopidogrel and ticagrelor We hypothesize that genetic variation in CES1 will significantly impact on-clopidogrel platelet aggregation while having a minimal effect in ticagrelor-treated subjects
Specific Aim To conduct a prospective randomized crossover study of clopidogrel and ticagrelor in healthy individuals stratified by CES1 genotype Participants will be recruited by CES1 genotype into a randomized crossover study of clopidogrel 75 mg daily for 7d and ticagrelor 90 mg twice daily for 7d with extensive phenotyping including ex vivo platelet aggregometry performed pre- and post-drug administration in order to assess the interaction of genotype and drug choice on on-treatment platelet function
Specific Aim To conduct a prospective randomized crossover study of clopidogrel and ticagrelor in healthy individuals stratified by CES1 genotype Participants will be recruited by CES1 genotype into a randomized crossover study of clopidogrel 75 mg daily for 7d and ticagrelor 90 mg twice daily for 7d with extensive phenotyping including ex vivo platelet aggregometry performed pre- and post-drug administration in order to assess the interaction of genotype and drug choice on on-treatment platelet function
Detailed Description:
None
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?:
True
Is an FDA AA801 Violation?:
None