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

Completed

• Conditions: Obesity; Heart Diseases; Hypertension; Coronary Disease; Cardiovascular Diseases; Carotid Artery Diseases; Insulin Resistance; Diabetes Mellitus; Diabetes Mellitus, Non-insulin Dependent

• Registration Number: NCT00035711
• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary

To evaluate additional cardiovascular risk factors using data from the VA HDL Intervention Trial (VA-HIT).

Detailed Description

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.

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

Study Timeline

• Study Start: 2001-09
• Study First Submitted: 2002-05-04
• Study First Submitted QC: 2002-05-04
• Study First Posted: 2002-05-06
• Study Completion: 2004-08
• Status Verified: 2005-11
• Last Update Submitted: 2016-03-15
• Last Update Posted: 2016-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified