Ignite Creation Date:
2024-05-05 @ 9:11 PM
Last Modification Date:
2024-10-26 @ 10:01 AM
Study NCT ID:
NCT00839345
Status:
TEMPORARILY_NOT_AVAILABLE
Last Update Posted:
2019-02-01
First Post:
2009-02-06
Brief Title:
Clopidogrel Resistance and the Possibility of Its Affection
Sponsor:
Charles University Czech Republic
Organization:
Charles University Czech Republic
Study Overview
Official Title:
Resistance to Antiplatelet Agents Its Etiology and the Possibility of Its Affection
Status:
TEMPORARILY_NOT_AVAILABLE
Status Verified Date:
2019-01
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:
None
Brief Summary:
The purpose of the study is to determine whether the resistance to clopidogrel could be affected by higher doses of this drug or by replacement of clopidogrel with another ADP-antagonist ticlopidine
Detailed Description:
Patients after percutaneous coronary intervention PCI with stent implantation have to be treated by dual antiplatelet therapy which standard part represents clopidogrel The response to clopidogrel in population exhibits wide interindividual variability According to some recent works patients with clopidogrel resistance are in higher risk for recurrence of myocardial infarction in comparison with the patients with sufficient clopidogrel effectiveness The treatment of clopidogrel resistance is still unknown Our project should contribute to the better understanding of the clinical impact of clopidogrel resistance and its genetical determination We will test the hypothesis whether the clopidogrel resistance could be influenced by higher dose of this drug or by replacement to ticlopidine ADP antagonist with different biotransformation in the liver Therefore 500 pts will be tested to clopidogrel resistance We expect 5-10 of resistent pts This pts will be treated by higher dose 150mg or 225mgday with repeated tests of clopidogrel effectiveness after each dose enhancement If 225mgday will be insufficient clopidogrel will be replaced by ticlopidine with repeated test We expect that better definition of clinical and and genetic correlate of clopidogrel resistance will improve our knowledge of this disorder Nevertheless the achievement of sufficient effect of clopidogrel in some still resistant patients will lead to the improvement of the treatment
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