Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial to Assess the Efficacy of Combination Formula of Aspirin Plus Clopidogrel in Patients With Coronary Stent

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: NCT02410083
Recruitment Status : Completed
First Posted : April 7, 2015
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
Jeil Pharmaceutical Co., Ltd.

Brief Summary:
The purpose of this study in to evaluate efficacy and tolerability of Clopirin and clopidogrel with aspirin in Korean Patients with post-percutaneous coronary artery intervention.

Condition or disease Intervention/treatment Phase
ANEURYSM CORONARY ARTERY Drug: Clopirin 1 Drug: Clopidogrel-Aspirin(co-administration) 1 Drug: Clopirin 2 Drug: Clopidogrel-Aspirin(co-administration) 2 Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 448 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized, Open Study, Investigator-initiated Trial for Comparison of Eight Weeks Efficacy and Tolerability of Clopirin and Clopidogrel With Aspirin in Korean Patients With Post-Percutaneous Coronary Artery Intervention
Study Start Date : November 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : December 2015


Arm Intervention/treatment
Experimental: Clopirin 1
Clopirin single-administration. Before this clinical trial Clopidogrel/Aspirin co-administration.
Drug: Clopirin 1
Active Comparator: Clopidogrel/Aspirin co-administration 1
Clopidogrel-aspirin co-administration. Before this clinical trialClopidogrel/Aspirin co-administration.
Drug: Clopidogrel-Aspirin(co-administration) 1
Experimental: Clopirin 2
Clopirin single-administration. Before this clinical trial Aspirin single-administration.
Drug: Clopirin 2
Active Comparator: Clopidogrel/Aspirin co-administration 2
Clopidogrel-aspirin-co-administration. Before this clinical trial Aspirin single-administration.
Drug: Clopidogrel-Aspirin(co-administration) 2



Primary Outcome Measures :
  1. % inhibition =△Purinergic receptor, G-protein coupled, 12 Reaction Units(PRU)/ Pretreatment PRU [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. △ PRU = Post treatment PRU - Pre treatment PRU [ Time Frame: 8 weeks ]
  2. △ ARU = Post treatment Aspirin resistance unit(ARU) - Pre treatment ARU [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Over 3 months, the patient who were the administration of aspirin or the co-administration of clopidogrel-aspirin coronary artery patients after treated with Percutaneous Coronary Intervention(PCI) that have safety progress.
  • Korean men and women between the age of 20 and 85
  • Patients who understand the study requirements, are willing to comply with all study procedures and have provided written informed consent.

Exclusion Criteria:

  • Patients who were not treated with PCI or intended to treat with PCI but failed.
  • Patients who were taking or had taken other antiplatelet or anticoagulant for more than 2 weeks within the prior 30 days.
  • Patients who had a history of alcohol abuse or intoxication.
  • Patients who had hypersensitivity to clopidogrel or aspirin.
  • Patients who had severe hepatic dysfunction aspartate aminotransferase(AST) or alanine aminotransferase(ALT) > 3 times upper normal reference values.
  • Patients who had blood coagulation disorders, uncontrolled severe hypertension, active bleeding, or history of severe bleeding, such as intracranial hemorrhage or ulcer bleeding - surgery within 48hr, platelet counts below 50,000/mm3 in laboratory tests.
  • Patients who were pregnant, breastfeeding.
  • Patients who were not using effective methods of contraception. (proper contraception : hormonal contraception, condom, intrauterine device, spermicide)
  • Patients who medically, psychologically had investigational product administration's prohibition.
  • Patients who were not participated in this clinical trial decided by other investigators.

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): NCT02410083


Sponsors and Collaborators
Jeil Pharmaceutical Co., Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Hyo-soo Kim, Professor Seoul National University Hospital

Layout table for additonal information
Responsible Party: Jeil Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02410083     History of Changes
Other Study ID Numbers: JP_CLN_01
First Posted: April 7, 2015    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Aspirin
Clopidogrel
Aneurysm
Coronary Aneurysm
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases
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 P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents