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NCT00917527 Clinical Trial

Endothelial Dysfunction in Subjects With History of Premature Coronary Artery Disease

Coronary Heart Disease Clinical Trial

Official title:
Randomized Placebo-controlled Crossover Trial of Endothelial Function Improvement in Subjects With History of Premature Coronary Artery Disease

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00917527
Other study ID # 20090615
Secondary ID
Status Recruiting
Phase Phase 4
First received June 9, 2009
Last updated July 20, 2012
Start date June 2009
Est. completion date June 2013

Study information
Verified date July 2012
Source Yonsei University
Contact Hyuk-Jae Chang, MD, PhD
Phone 82-2-2228-8461
Email hjchang@yuhs.ac
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 77
Est. completion date June 2013
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Atorvastatin
Atorvastatin 40mg/D for 6 weeks to improve endothelial dysfunction

Locations
Country Name City State
Korea, Republic of Severance Cardiovascular Hospital, Yonsei University College of Medicine Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Nasir K, Michos ED, Rumberger JA, Braunstein JB, Post WS, Budoff MJ, Blumenthal RS. Coronary artery calcification and family history of premature coronary heart disease: sibling history is more strongly associated than parental history. Circulation. 2004 Oct 12;110(15):2150-6. Epub 2004 Oct 4. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary improvement of endothelial dysfunction with endo-PAT2000 6 weeks later drug administration No
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