Comparison of the Efficacy and Safety of Closone and Clopidogrel With Aspirin

NCT01763749 | Completed Phase 4

• 1 other identifier: CLO_1201
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Change from baseline in P2Y12% inhibition at week 4

  Baseline, week 4

Secondary Outcomes (3)

• Change from baseline in VerifyNow P2Y12 reaction unit at week 4

  Baseline, week 4

• Change from baseline in VerifyNow Aspirin Reaction Unit at week 4

  Baseline, week 4

• Change from baseline in maxymal platelet aggregation at week 4

  Baseline, week 4

Other Outcomes (1)

• Adverse events

  Baseline, week 4

Study Arms (2)

Closone

EXPERIMENTAL

75mg/100mg per day, 4weeks, PO

Drug: Closone

Plavix with Astrix

ACTIVE COMPARATOR

Plavix 75mg with Astrix 100mg, 4weeks, PO

Drug: Plavix with Astrix

Interventions

Closone DRUG

Closone 75mg/100mg, 4weeks, PO

Closone

Plavix with Astrix DRUG

Plavix 75mg with Astrix 100mg, 4weeks, PO

Plavix with Astrix

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects under condition after Post-Percutaneous Coronary Artery Intervention over twelve months
• \~85 years old
• Willing to adhere to protocol requirements and sign a informed consent form

You may not qualify if:

• Subject who did not undergo or failed Stent Implantation
• Subjects who took an anti-coagulant, anti-thrombotic regularly before the study, or plan to have continuous treatment during the study
• Subjects with a history of hypersensitivity to Clopidogrel, Aspirin
• Subjects with uncontrolled severe hypertension
• Subjects with high risk of hemorrhage like blood coagulation disorders
• :gastrointestinal bleeding, gross hematuria, intraocular bleeding, hemorrhagic stroke, intracranial hemorrhage
• Subjects with intractable arrhythmia, intracranial hemorrhage
• Subjects with Severe cardiomyopathy (New York Heart Association(NYHA) Class Ⅳ)
• Subjects with Severe hepatopathy(AST and ALT \> 10 times the upper limit of normal)
• Subjects who are pregnant, breastfeeding and not using medically acceptable birth control
• Subjects considered as unsuitable based on medical judgement by investigators

Sponsors & Collaborators

• Seoul St. Mary's Hospital: lead

Study Sites (1)

Cardiovascular Center and Cardiology Division, Seoul St. Mary's Hospital

Seoul, Seochogu, 137-701, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ki-Bae Seung, MD, PhD

  Cardiovascular center and Cardiology Division, Seoul St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 7, 2013
• First Posted: January 9, 2013
• Study Start: October 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 3, 2015

Record last verified: 2015-02

Locations

KR (1)