Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00037401
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2002-05-16
Brief Title:
Postprandial Lipemia and Endothelial Function in ACCORD- Ancillary to ACCORD
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:
2008-01
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 compare the effects of statin therapy alone with statin plus fibrate therapy on several emerging risk factors for atherosclerotic cardiovascular disease in a representative subgroup of the ACCORD cohort that is being followed for cardiovascular endpoints
Detailed Description:
BACKGROUND
The National Heart Lung and Blood Institute-supported ACCORD trial uses two connected 2x2 designs to test the efficacy of a optimal glucose control HbA1c 60 versus standard control HbA1c 75 in 10000 patients with type 2 diabetes mellitus b more intense systolic blood pressure control 120 mm Hg versus less intense control 140 mm Hg in 4200 of those patients and c combined low density lipoprotein cholesterol lowering triglyceride lowering and high density lipoprotein cholesterol raising versus only low density lipoprotein cholesterol lowering in 5800 of those patients The primary outcome for the overall ACCORD trial is a combination of non-fatal myocardial infarction non-fatal stroke and cardiovascular death The comparison of lipid-altering therapies is carried out in the Lipid Arm of ACCORD in which the 5800 subjects are treated with simvastatin and in addition are randomly assigned to receive either fenofibrate or placebo The main ACCORD trial measures only fasting blood samples for lipids lipoprotein fractions and apolipoproteins The ancillary study compares the effects of simvastatin plus fenofibrate with the effects of simvastatin alone on postprandial lipemia in 250 ACCORD patients at 4 sites in the Northeast Network
The study is in response to an initiative on Ancillary Studies in Heart Lung and Blood Disease Trials released in June 2000
DESIGN NARRATIVE
The ancillary study compares the effects of simvastatin plus fenofibrate with the effects of simvastatin alone on postprandial lipemia in 250 ACCORD patients at 4 sites in the Northeast Network In addition the study compare the effects of the two treatment strategies on baseline and postprandial endothelial function and on markers of coagulation endothelial function and oxidative stress The ancillary study provides a unique opportunity to determine possible mechanisms whereby simvastatin plus fenofibrate therapy may be associated with reduced cardiovascular events in the overall ACCORD trial The study is divided into three specific aims Specific Aim A To carry out high fat load studies of postprandial lipemia in patients who are participating in the Lipid Arm of the ACCORD trial and compare postprandial excursions of triglycerides triglyceride-rich lipoproteins retinyl palmitate and remnant lipoprotein cholesterol in patients receiving fenofibrate plus simvastatin with those postprandial excursions in patients receiving only simvastatin Specific Aim B To determine brachial artery dilatation in response to increased blood flow post- forearm ischemia just prior to and five hours after ingestion of a high fat load in the two patient groupsand Specific Aim C To determine baseline levels of PAI-1 fibrinogen and factor VII and postprandial excursions of factor VII sVCAM-1 sICAM-1 and sE-selectin in the two patient groups
The National Heart Lung and Blood Institute-supported ACCORD trial uses two connected 2x2 designs to test the efficacy of a optimal glucose control HbA1c 60 versus standard control HbA1c 75 in 10000 patients with type 2 diabetes mellitus b more intense systolic blood pressure control 120 mm Hg versus less intense control 140 mm Hg in 4200 of those patients and c combined low density lipoprotein cholesterol lowering triglyceride lowering and high density lipoprotein cholesterol raising versus only low density lipoprotein cholesterol lowering in 5800 of those patients The primary outcome for the overall ACCORD trial is a combination of non-fatal myocardial infarction non-fatal stroke and cardiovascular death The comparison of lipid-altering therapies is carried out in the Lipid Arm of ACCORD in which the 5800 subjects are treated with simvastatin and in addition are randomly assigned to receive either fenofibrate or placebo The main ACCORD trial measures only fasting blood samples for lipids lipoprotein fractions and apolipoproteins The ancillary study compares the effects of simvastatin plus fenofibrate with the effects of simvastatin alone on postprandial lipemia in 250 ACCORD patients at 4 sites in the Northeast Network
The study is in response to an initiative on Ancillary Studies in Heart Lung and Blood Disease Trials released in June 2000
DESIGN NARRATIVE
The ancillary study compares the effects of simvastatin plus fenofibrate with the effects of simvastatin alone on postprandial lipemia in 250 ACCORD patients at 4 sites in the Northeast Network In addition the study compare the effects of the two treatment strategies on baseline and postprandial endothelial function and on markers of coagulation endothelial function and oxidative stress The ancillary study provides a unique opportunity to determine possible mechanisms whereby simvastatin plus fenofibrate therapy may be associated with reduced cardiovascular events in the overall ACCORD trial The study is divided into three specific aims Specific Aim A To carry out high fat load studies of postprandial lipemia in patients who are participating in the Lipid Arm of the ACCORD trial and compare postprandial excursions of triglycerides triglyceride-rich lipoproteins retinyl palmitate and remnant lipoprotein cholesterol in patients receiving fenofibrate plus simvastatin with those postprandial excursions in patients receiving only simvastatin Specific Aim B To determine brachial artery dilatation in response to increased blood flow post- forearm ischemia just prior to and five hours after ingestion of a high fat load in the two patient groupsand Specific Aim C To determine baseline levels of PAI-1 fibrinogen and factor VII and postprandial excursions of factor VII sVCAM-1 sICAM-1 and sE-selectin in the two patient groups
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 |
|---|---|---|---|
| R01HL069190 | NIH | None | httpsreporternihgovquickSearchR01HL069190 |