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Endothelial Dysfunction in Subjects With History of Premature Coronary Artery Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Yonsei University.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Hyuk-Jae Chang, Yonsei University Identifier:
First received: June 9, 2009
Last updated: July 20, 2012
Last verified: July 2012
The aim of this prospective study is to investigate the prevalence of endothelial dysfunction in subjects with family history of premature coronary heart disease. At the same time, the effect of atorvastatin in treating subclinical endothelial dysfunction in those patients will be evaluated.

Condition Intervention Phase
Coronary Heart Disease
Drug: Atorvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Placebo-controlled Crossover Trial of Endothelial Function Improvement in Subjects With History of Premature Coronary Artery Disease

Resource links provided by NLM:

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • improvement of endothelial dysfunction with endo-PAT2000 [ Time Frame: 6 weeks later drug administration ] [ Designated as safety issue: No ]

Estimated Enrollment: 77
Study Start Date: June 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control Drug: Atorvastatin
Atorvastatin 40mg/D for 6 weeks to improve endothelial dysfunction
Experimental: Atorvastatin Drug: Atorvastatin
Atorvastatin 40mg/D for 6 weeks to improve endothelial dysfunction


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • within 1 year
  • the siblings of premature coronary heart disease(male<55years old, female<65years old: Framingham Heart Study)patients admitted relevant hospital

Exclusion Criteria:

  • Documented coronary heart disease
  • Any woman of childbearing potential who is pregnant, seeking to become pregnant or suspects that she may be pregnant.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00917527

Contact: Hyuk-Jae Chang, MD, PhD 82-2-2228-8461

Korea, Republic of
Severance Cardiovascular Hospital, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Hyuk-Jae Chang, MD, PhD         
Sponsors and Collaborators
Yonsei University
Principal Investigator: Hyuk-Jae Chang, MD, PhD Cardiology Division, Severance Cardiovascular Hospital, Yonsei University College of Medicine
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hyuk-Jae Chang, Yonsei University Identifier: NCT00917527     History of Changes
Other Study ID Numbers: 20090615 
Study First Received: June 9, 2009
Last Updated: July 20, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Yonsei University:
Subjects with family history of coronary heart disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors processed this record on October 21, 2016