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Phase IV Study to Compare Efficacy and Safety of Plavix 75mg With Astrix 100mg and Closone

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
CJ Cheiljedang Corporation
ClinicalTrials.gov Identifier:
NCT01765452
First received: January 7, 2013
Last updated: April 30, 2013
Last verified: January 2013
History of Changes
  Purpose

The Aim of this study is to prove non-inferiority of Closone to the Combination treatment of Plavix with Astrix.


Condition Intervention Phase
Coronary Artery Disease
 Drug: Closone
Drug: Plavix with Astrix
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-center, Randomized, Open Study for Comparison of Efficacy and Safety of Plavix With Astrix and Closone in Patients With Post-Percutaneous Coronary Artery Intervention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by CJ Cheiljedang Corporation:

Primary Outcome Measures:
  • Change from baselinine in P2Y12% inhibition at week 8 [ Time Frame: Baseline, week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in PRU, ARU at week 8 [ Time Frame: Baseline, week 8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 268
Study Start Date: October 2012
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Closone
75mg/100mg per day, 8weeks, PO
 Drug: Closone
75mg/100mg, 8weeks, PO
Active Comparator: Plavix with Astrix
75mg per day, 8weeks, PO 100mg per day, 8weeks, PO
 Drug: Plavix with Astrix
75mg, 100mg a day, 8weeks, PO

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects under a stable condition after Post-Percutaneous Coronary Artery Intervention over three months
  • 20~86 years old
  • Willing to adhere to protocol requirements and sign a informed consent form

Exclusion Criteria:

  • Subject who did not undergo or failed Drug-Stent Implantation
  • Subjects who took an anti-coagulant, anti-thrombotic regularlly( ≥ 2weeks in a month) before the study, or plan to have continuous treatment during the study(Except Aspirin alone or combination of Aspirin and Clopidogrel)
  • Subjects with a history of substance or alchol abuse
  • Subjects with a history of hypersensitivity to Clopidogrel, Aspirin or other NSAIDS
  • Subjects having Aspirin or other NSAIDs-induced Asthma or history
  • Subjects with Severe hepatopathy(AST and ALT > 5 times the upper limit of normal)
  • Subjects with Severe nephropathy(Cr > 3 times the upper limit of normal)
  • Subjects with hemorrhage like gastric ulcer, intracranial hemorrhage etc.
  • Subjects with high risk of hemorrhage like blood coagulation disorders, uncontrolled severe hypertension, active bleeding, history of severe bleeding
  • subjects who are pregnant, breastfeeding
  • Subjects not using medically acceptable birth control
  • Subjects who are unsuitable to take the Investigational product due to a medical/mental condition
  • Subjects inherently having Galactose malobsorption, Lactase deficiency or Glucose-Galactose malobsorption
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01765452

Locations
Korea, Republic of
Inje university haeundae paik hospital
Busan, Korea, Republic of
Kosin university gospel hospital
Busan, Korea, Republic of
Pusan national university hospital
Busan, Korea, Republic of
Chungbuk national university hospital
Chungbuk, Korea, Republic of
Dongguk University Medical Center
Gyeonggi-do, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
SNU Boramae Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
CJ Cheiljedang Corporation
  More Information

No publications provided

Responsible Party: CJ Cheiljedang Corporation
ClinicalTrials.gov Identifier: NCT01765452     History of Changes
Other Study ID Numbers: CJ_CLO_401
Study First Received: January 7, 2013
Last Updated: April 30, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
Platelet Aggregation Inhibitors
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013