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OpenTrials
Completed

NCT Number: NCT02410083

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

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.

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Key information

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clopirin 1

Drug

Clopidogrel-Aspirin(co-administration) 1

Drug

Clopirin 2

Drug

Clopidogrel-Aspirin(co-administration) 2

Drug

Primary outcomes

  1. % inhibition =△Purinergic receptor, G-protein coupled, 12 Reaction Units(PRU)/ Pretreatment PRU

    Time frame: 8 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Jeil Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2015
First posted
Apr 7, 2015
Registry last updated
Mar 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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