DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Clopidogrel Resistance and the Possibility of Its Affection

Information source: Charles University, Czech Republic
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Coronary Artery Disease

Intervention: clopidogrel (Drug)

Phase: N/A

Status: Temporarily not available

Sponsored by: Charles University, Czech Republic

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.

Clinical Details

Official title: Resistance to Antiplatelet Agents, Its Etiology and the Possibility of Its Affection

Study design: N/A

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

Eligibility

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.

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)

Locations and Contacts

Cardiocenter, Dept. Of Cardiology, Charles University Hospital, Prague 10034, Czech Republic
Additional Information


Last updated: February 9, 2009

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017