Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00037401 |
| Other study ID # |
1168 |
| Secondary ID |
R01HL069190 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
May 16, 2002 |
| Last updated |
February 17, 2016 |
| Start date |
September 2001 |
| Est. completion date |
August 2005 |
Study information
| Verified date |
January 2008 |
| 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 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.
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 = 6.0%) versus standard
control (HbA1c + 7.5%) in 10,000 patients with type 2 diabetes mellitus, (b) more intense
systolic blood pressure control (120 mm Hg) versus less intense control (140 mm Hg) in 4,200
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 5,800 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 5,800 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 groups.and 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.
