Ignite Creation Date:
2024-05-05 @ 11:31 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01341600
Status:
COMPLETED
Last Update Posted:
2024-01-30
First Post:
2011-04-22
Brief Title:
Clopidogrel Pharmacogenetics PGX Bench to Bedside
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Clopidogrel Pharmacogenetics Bench to Bedside - A Practical Application
Status:
COMPLETED
Status Verified Date:
2024-01
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:
PGXB2B
Brief Summary:
Clopidogrel also known as Plavix is used commonly in patients to prevent heart attacks and conditions caused by blood clots Although clopidogrel works in many individuals some people do not respond as well to this drug The variation in treatment response may be linked to genetics This study will examine the effects of clopidogrel in a population in which sequencing for certain genes has been performed in order to determine the role that genes play in the response to various clopidogrel maintenance doses
Detailed Description:
Clopidogrel is a prodrug with high inter-individual response variability Clopidogrel is converted to an active drug in part through an enzyme encoded by the gene named CYP2C19 Individuals with genetically-impaired CYP2C19 metabolism have lower capacity to convert the prodrug to its active form Consequently these individuals have lower blood levels of the activated form of clopidogrel diminished antiplatelet responses and higher rates of cardiovascular events and stent thrombosis Increasing doses of clopidogrel in such patients represents a possible approach to managing the gene-drug interaction
The purpose of this study is to evaluate whether increasing the dose of clopidogrel increases antiplatelet responses and active metabolite exposure in individuals with genetically reduced CYP2C19 metabolism relative to those with normal CYP2C19 metabolism
The primary objective is to assess changes in clopidogrel response and exposure at three clopidogrel dose levels and with coadministration of omeprazole
The purpose of this study is to evaluate whether increasing the dose of clopidogrel increases antiplatelet responses and active metabolite exposure in individuals with genetically reduced CYP2C19 metabolism relative to those with normal CYP2C19 metabolism
The primary objective is to assess changes in clopidogrel response and exposure at three clopidogrel dose levels and with coadministration of omeprazole
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 |
|---|---|---|---|
| ZICSC006537 | NIH | NIH | httpsreporternihgovquickSearchZICSC006537 |
| U01GM074518 | NIH | None | None |
| U01HL105198 | NIH | None | None |
| 128475 | OTHER_GRANT | None | None |
| ZICSC006536 | NIH | None | None |