VA HDL Intervention Trial (VA-HIT) Ancillary Study Data Analysis

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00035711
First received: May 4, 2002
Last updated: November 10, 2005
Last verified: November 2005

May 4, 2002
November 10, 2005
September 2001
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Complete list of historical versions of study NCT00035711 on ClinicalTrials.gov Archive Site
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VA HDL Intervention Trial (VA-HIT) Ancillary Study Data Analysis
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To evaluate additional cardiovascular risk factors using data from the VA HDL Intervention Trial (VA-HIT).

BACKGROUND:

The VA HDL Intervention trial (VA-HIT) was a multicenter, placebo controlled, randomized trial that showed that gemfibrozil significantly reduced major cardiovascular events in 2531 men with coronary heart disease, low levels of low density lipoprotein (LDL) cholesterol and low levels of high density lipoprotein (HDL) cholesterol. In addition to its unique lipid profile, the VA-HIT population also had a high prevalence of diabetes, impaired fasting glucose, or high fasting plasma insulin; central obesity; and hypertension, which are all components (together with high triglycerides and low HDL-cholesterol) of a constellation of risk factors known as the metabolic syndrome. Since prior clinical trials have not enrolled this type of population, the VA- HIT database is a unique resource.

DESIGN NARRATIVE:

The study used the VA-HIT database to study additional risk markers that were measured in the study population of 2,531 men with coronary heart disease. Specific analyses were: 1) the association between levels of glucose tolerance, insulin resistance and other features of the metabolic syndrome, occurrence of major cardiovascular outcomes, and gemfibrozil efficacy; 2) the effect of gemfibrozil on progression of carotid atherosclerosis, as measured by B-mode ultrasound; 3) the association between LDL particle size distribution and lipoprotein subclass distribution; homocysteine; lipoprotein(a); C-reactive protein, tissue plasminogen activator; fibrinogen; and factor VII; major cardiovascular outcomes and gemfibrozil efficacy.

Observational
Observational Model: Defined Population
Time Perspective: Retrospective
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  • Coronary Disease
  • Heart Diseases
  • Cardiovascular Diseases
  • Carotid Artery Diseases
  • Diabetes Mellitus, Non-Insulin Dependent
  • Hypertension
  • Insulin Resistance
  • Obesity
  • Diabetes Mellitus
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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August 2004
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No eligibility criteria

Male
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00035711
1008
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National Heart, Lung, and Blood Institute (NHLBI)
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Investigator: Hanna Rubins Department of Veterans Affairs
National Heart, Lung, and Blood Institute (NHLBI)
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP