Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00035711
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2002-05-04
Brief Title:
VA HDL Intervention Trial VA-HIT Ancillary Study Data Analysis
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 2531 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 lipoproteina 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
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 2531 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 lipoproteina 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R03HL069111 | NIH | None | httpsreporternihgovquickSearchR03HL069111 |