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Trial record 38 of 509 for:    ASPIRIN AND P2

Korean Multicenter Randomized Controlled Trial (RCT) of Pidogul for Patients With Coronary Stenting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01584791
Recruitment Status : Completed
First Posted : April 25, 2012
Last Update Posted : April 25, 2012
Sponsor:
Collaborator:
Hanmi Pharmaceutical co., ltd.
Information provided by (Responsible Party):
Hyo-Soo Kim, Seoul National University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Coronary Artery Disease Drug: clopidogrel napadisilate + aspirin Drug: clopidogrel bisulfate + aspirin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2010
Actual Primary Completion Date : February 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. The percentage of P2Y12 receptor inhibition [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Adverse events after study medication [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01584791


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Hanmi Pharmaceutical co., ltd.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
First Posted: April 25, 2012    Key Record Dates
Last Update Posted: April 25, 2012
Last Verified: April 2012
Keywords provided by Hyo-Soo Kim, Seoul National University Hospital:
CAD
PCI
Percutaneous Coronary Intervention
Additional relevant MeSH terms:
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Aspirin
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents