Status:
COMPLETED
Efficacy and Tolerability of Clopidogrel Resinate and Clopidogrel Bisulfate in Patients With Coronary Heart Disease (CHD) or CHD Equivalents
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
CKD Pharmaceutical Limited
Conditions:
Coronary Heart Disease
Eligibility:
All Genders
20-85 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the efficacy and tolerability between clopidogrel resinate and clopidogrel bisulfate in patients with coronary heart disease (CHD) or CHD equivalents.
Eligibility Criteria
Inclusion
- Korean men and women aged 20 to 85 years with coronary heart disease (CHD) or CHD equivalent patients
- Atherosclerotic plaques in coronary computed tomography (CT) or angiography or
- History of PCI or coronary artery bypass graft surgery (CABG) \> one year or
- Diabetes mellitus (including type I and type II) or
- Confirmed carotid atherosclerotic plaque with sonography, CT or angiography or
- History of peripheral artery disease or
- History of cerebrovascular disease
Exclusion
- Patients who had history of PCI within one year
- Patients who used concomitant anticoagulants
- Patients who had hypersensitivity to aspirin or clopidogrel, serious bleeding tendency, history of intracranial hemorrhage, sign of active bleeding, uncontrolled hypertension
- Chronic alcoholism or drug addiction
- Women who were pregnant or breastfeeding or who were not using an effective method of contraception
- The use of glycoprotein IIb/IIIa inhibitor, daily NSAIDs, lipid lowering agent (except atorvastatin), or substances with possible interactions with the study drug
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
306 Patients enrolled
Trial Details
Trial ID
NCT00947843
Start Date
November 1 2013
End Date
October 1 2016
Last Update
October 13 2016
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