Korean Multicenter Randomized Controlled Trial (RCT) of Pidogul for Patients With Coronary Stenting
This study has been completed.
Sponsor:
Seoul National University Hospital
Collaborator:
Hanmi Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Hyo-Soo Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01584791
First received: April 23, 2012
Last updated: April 24, 2012
Last verified: April 2012
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Purpose
The aim of the current study is to compare the antiplatelet efficacy and safety of clopidogrel napadisilate and clopidogrel bisulfate in Coronary Artery Disease (CAD) patients after coronary stent implantation.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Drug: clopidogrel napadisilate + aspirin Drug: clopidogrel bisulfate + aspirin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Seoul National University Hospital:
Primary Outcome Measures:
- The percentage of P2Y12 receptor inhibition [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Adverse events after study medication [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 148 |
| Study Start Date: | October 2010 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: clopidogrel napadisilate + aspirin |
Drug: clopidogrel napadisilate + aspirin
clopidogrel napadisilate 75mg + aspirin 100mg
|
| Active Comparator: clopidogrel bisulfate + aspirin |
Drug: clopidogrel bisulfate + aspirin
clopidogrel bisulfate 75mg + aspirin 100mg
|
Eligibility| Ages Eligible for Study: | 20 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Korean men and women between the age of 20 and 85
- Patients who were diagnosed as having CAD
- Patients who were planned to undergo PCI
Exclusion Criteria:
- Patients who were not treated with PCI or intended to treat with PCI but failed
- Patients who were were taking or had taken other antiplatelet or anticoagulant for more than 2 weeks within the prior 30 days
- Patients who were had a history of alcohol abuse or intoxication; (4) had hypersensitivity to clopidogrel or aspirin
- Patients who were had hypersensitivity to clopidogrel or aspirin
- Patients who were had abnormal laboratory results indicative of liver disease
- Patients who were had blood coagulation disorders, uncontrolled severe hypertension, active bleeding, or history of severe bleeding, such as intracranial hemorrhage or ulcer bleeding
- Patients who were were pregnant, breastfeeding, or not using effective methods of contraception
- Patients who were had other contraindication to study drug
- Patients who were had participated in another clinical study within 4 weeks prior to the start of this study
Contacts and Locations More Information
No publications provided
| Responsible Party: | Hyo-Soo Kim, Professor, Department of Internal Medicine, Seoul National University Hospital, Seoul National University Hospital |
| ClinicalTrials.gov Identifier: | NCT01584791 History of Changes |
| Other Study ID Numbers: | KOPIDO STENT |
| Study First Received: | April 23, 2012 |
| Last Updated: | April 24, 2012 |
| Health Authority: | South Korea: Institutional Review Board South Korea: Korea Food and Drug Administration (KFDA) |
Keywords provided by Seoul National University Hospital:
|
CAD PCI Percutaneous Coronary Intervention |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Aspirin Ticlopidine Clopidogrel Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics |
ClinicalTrials.gov processed this record on October 17, 2012
