Ignite Creation Date:
2024-05-05 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 9:58 AM
Study NCT ID:
NCT00799396
Status:
COMPLETED
Last Update Posted:
2022-02-24
First Post:
2008-11-26
Brief Title:
Determining Genetic Role in Treatment Response to Anti-Platelet Interventions The PAPI Study
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Pharmacogenomics of Anti-Platelet Interventions The PAPI Study
Status:
COMPLETED
Status Verified Date:
2022-02
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:
One of the most common ways for preventing coronary heart disease CHD is to take aspirin or clopidogrel However studies have shown that not all people respond to these medications The variance in treatment response may be linked to genetics This study will examine the effects of aspirin and clopidogrel in a population whose genes are well known in order to determine the role that genes play in treatment responses
Detailed Description:
CHD is the leading cause of death in the United States Anti-platelet agents lessen platelet aggregation and are used commonly to prevent recurrent CHD events Two of the most common anti-platelet agents are aspirin and clopidogrel However up to 25 to 30 of people do not respond to these medications Evidence indicates that treatment response may be related to genetics The purpose of this study is to determine specific gene variants that predict response to aspirin and clopidogrel therapy
This study is part of a larger group of studies called the Pharmacogenomics Research Network PGRN Participants will include the Old Order Amish of Lancaster Pennsylvania They are well suited for genetic studies because they are a homogenous closed founder population Participants will receive 300 mg of clopidogrel on the first day then 75 mg of clopidogrel per day for the next 6 days On the last day of clopidogrel treatment participants will take a single dose of 324 mg aspirin Participants will undergo platelet function tests before and after clopidogrel alone and then again after taking clopidogrel plus aspirin Using the gene variation profiles across the genome researchers will analyze which genes correspond to treatment response
This study is part of a larger group of studies called the Pharmacogenomics Research Network PGRN Participants will include the Old Order Amish of Lancaster Pennsylvania They are well suited for genetic studies because they are a homogenous closed founder population Participants will receive 300 mg of clopidogrel on the first day then 75 mg of clopidogrel per day for the next 6 days On the last day of clopidogrel treatment participants will take a single dose of 324 mg aspirin Participants will undergo platelet function tests before and after clopidogrel alone and then again after taking clopidogrel plus aspirin Using the gene variation profiles across the genome researchers will analyze which genes correspond to treatment response
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 |
|---|---|---|---|
| U01 HL074518-01 | None | None | None |
| U01GM074518 | NIH | None | httpsreporternihgovquickSearchU01GM074518 |