Ignite Creation Date:
2024-05-05 @ 11:39 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01381185
Status:
COMPLETED
Last Update Posted:
2016-10-27
First Post:
2011-06-22
Brief Title:
REsistance to Aspirin and Clopidogrel in acuTe Myocardial Infarction
Sponsor:
University Hospital Ostrava
Organization:
University Hospital Ostrava
Study Overview
Official Title:
Phase IV Study of Aspirin and Clopidogrel Therapy Tailored by Functional Thrombocyte Examination PFA-100 LTA and VerifyNOW in Acute Myocardial Infarction
Status:
COMPLETED
Status Verified Date:
2016-10
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:
REACT-MI
Brief Summary:
The purpose of this study is to compare 3 point-of-care methods for monitoring antiplatelet therapy to golden standard Light transmittance aggregometry-LTA in high risk population of acute myocardial infarction patients If two methods PFA-100 VerifyNOWMultiplate or LTA will indicate insufficient antiplatelet blockadehigh residual reactivity for aspirin clopidogrel or both the dose of aspirin will be increased to 200mg qd and the dose of clopidogrel will be increased to 2x75mg qdIn addition genotyping of CYP2C19 6 alleles will be performed
Detailed Description:
Dual antiplatelet therapy is the cornerstone of treatment of coronary heart disease after coronary stent implantation The interindividual response to this therapy is not uniform however There are subgroups of patients where no anticipated antiplatelet effect to either aspirin clopidogrel or both is reached The term of aspirinclopidogrel resistance has been introduced few years ago most recently it was substituted by more suitable term - high on-treatment residual platelet reactivity HPR Although there are many assays to monitor antiplatelet therapy uncertainty still remains about the correlation of HPR with ischemic vascular events in-stent thrombosis myocardial infarction etc Thus platelet aggregation testing is considered to be the most promising method to indicate inappropriatelow response to aspirinclopidogrel however the best suited method is not established yet Up-to date light transmittance aggregometry is widely accepted as golden standard nonetheless labour intensive and difficult to standardize On the other hand many point-of-care aggregation testing methods like PFA-100 VerifyNOW Multiplate etc have been introduced their role in clinical practice is uncertain however The biggest challenge of today is to determine platelet function assay which could reliably indicate future ischemic vascular eventsmoreover it could be potentially used to tailor antiplatelet therapy and precede these events It was demonstrated that gene polymorphism - CYP2C192 and CYP2C93 loss of function is conjugated with an increased occurrence of stent thrombosis Within the project we also plan to examine 4 alleles which have not been examined in detail before
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 |
|---|---|---|---|
| plasek680 | OTHER | University Hospital Ostrava | None |