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

This study has been completed.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI) Identifier:
First received: May 4, 2002
Last updated: March 15, 2016
Last verified: November 2005
To evaluate additional cardiovascular risk factors using data from the VA HDL Intervention Trial (VA-HIT).

Coronary Disease
Heart Diseases
Cardiovascular Diseases
Carotid Artery Diseases
Diabetes Mellitus, Non-insulin Dependent
Insulin Resistance
Diabetes Mellitus

Study Type: Observational
Study Design: Time Perspective: Retrospective

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 2001
Study Completion Date: August 2004
Detailed Description:


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.


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.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.


Ages Eligible for Study:   up to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
No eligibility criteria
  Contacts and Locations
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Please refer to this study by its identifier: NCT00035711

Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
OverallOfficial: Hanna Rubins VA Office of Research and Development
  More Information Identifier: NCT00035711     History of Changes
Other Study ID Numbers: 1008
R03HL069111 ( US NIH Grant/Contract Award Number )
Study First Received: May 4, 2002
Last Updated: March 15, 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Cardiovascular Diseases
Heart Diseases
Insulin Resistance
Coronary Disease
Coronary Artery Disease
Carotid Artery Diseases
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Myocardial Ischemia
Vascular Diseases
Arterial Occlusive Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases processed this record on March 30, 2017