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

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

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.

Study Overview

• Status: Completed
• Conditions: ANEURYSM CORONARY ARTERY
• Intervention / Treatment: Drug: Clopirin 1; Drug: Clopidogrel-Aspirin(co-administration) 1; Drug: Clopirin 2; Drug: Clopidogrel-Aspirin(co-administration) 2

• Study Type: Interventional
• Enrollment (Actual): 448
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
% inhibition =△Purinergic receptor, G-protein coupled, 12 Reaction Units(PRU)/ Pretreatment PRU	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
△ PRU = Post treatment PRU - Pre treatment PRU	8 weeks
△ ARU = Post treatment Aspirin resistance unit(ARU) - Pre treatment ARU	8 weeks

Collaborators and Investigators

• Sponsor: Jeil Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Hyo-soo Kim, Professor, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: March 19, 2015
• First Submitted That Met QC Criteria: April 1, 2015
• First Posted (Estimate): April 7, 2015

Study Record Updates

• Last Update Posted (Actual): March 14, 2017
• Last Update Submitted That Met QC Criteria: March 12, 2017
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Aneurysm; Coronary Aneurysm; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Aspirin; Clopidogrel
• Other Study ID Numbers: JP_CLN_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No