Clopidogrel Resistance and the Possibility of Its Affection

NCT00839345 | Unknown

• 1 other identifier: CLO-OSM-01
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

platelet; clopidogrel; VerifyNow; ticlopidine; thrombosis

Interventions

clopidogrel DRUG

The intervention will involve the change of dosage or change of drug. The traditional maintenance dose of clopidogrel is 75 mg per day. We will test in non-responders to this classical dose higher doses up to 225mg per day. In patients,who will not respond to this 3times higher dose,clopidogrel will be replaced by ticlopidine.

Also known as: Plavix

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• written informed consent
• coronary artery disease verified by coronary angiography
• percutaneous coronary intervention with stent implantation
• standard indication for dual antiplatelet therapy

You may not qualify if:

• 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)

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (1)

Cardiocenter, Dept. Of Cardiology, Charles University Hospital

Prague, 10034, Czechia

Location

MeSH Terms

Conditions

Coronary Artery Disease; Thrombosis

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: February 6, 2009
• First Posted: February 9, 2009
• Last Updated: February 1, 2019

Record last verified: 2019-01

Locations

CZ (1)