Clopidogrel Resistance and the Possibility of Its Affection - Tabular View

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Tracking Information
First Received Date ^†	February 6, 2009
Last Updated Date	February 9, 2009
Start Date ^†
Current Primary Outcome Measures ^†
Original Primary Outcome Measures ^†
Change History	Complete list of historical versions of study NCT00839345 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^†
Original Secondary Outcome Measures ^†

Descriptive Information
Brief Title ^†	Clopidogrel Resistance and the Possibility of Its Affection
Official Title ^†	Resistance to Antiplatelet Agents, Its Etiology and the Possibility of Its Affection
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 225mg/day) with repeated tests of clopidogrel effectiveness after each dose enhancement. If 225mg/day 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 Phase
Study Type ^†	Expanded Access
Study Design ^†
Condition ^†	Coronary Artery Disease
Intervention ^†	Drug: clopidogrel
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Temporarily not available
Enrollment ^†
Completion Date
Primary Completion Date
Eligibility Criteria ^†	Inclusion Criteria: written informed consent coronary artery disease verified by coronary angiography percutaneous coronary intervention with stent implantation standard indication for dual antiplatelet therapy Exclusion Criteria: scheduled surgical revascularization by aortocoronary bypass insufficient cooperation of the patient coagulopathy in history with a higher risk of bleeding life expectancy shorter than 1 year severe anemia with hemoglobin level< 10,0 g/dl platelet count < 100,000)
Gender	Both
Ages	18 Years to 90 Years
Accepts Healthy Volunteers
Contacts ^††
Location Countries ^†	Czech Republic
Expanded Access Status	Temporarily not available

Administrative Information
NCT ID ^†	NCT00839345
Responsible Party	Pavel Osmancik, Charles University, Czech republic
Secondary IDs ^††
Study Sponsor ^†	Charles University, Czech Republic
Collaborators ^††
Investigators ^†
Information Provided By	Charles University, Czech Republic
Verification Date	February 2009
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.