Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00035711 |
| Other study ID # |
1008 |
| Secondary ID |
R03HL069111 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
May 4, 2002 |
| Last updated |
March 15, 2016 |
| Start date |
September 2001 |
| Est. completion date |
August 2004 |
Study information
| Verified date |
November 2005 |
| Source |
National Heart, Lung, and Blood Institute (NHLBI) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Observational
|
Clinical Trial Summary
To evaluate additional cardiovascular risk factors using data from the VA HDL Intervention
Trial (VA-HIT).
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.
