Coronary Artery Disease
Conditions
Keywords
Women with and without CAD
Brief summary
Several risk factors including high cholesterol contribute to heart disease. We know that lowering triglycerides and raising HDL (protective cholesterol) in men reduces the risk for heart disease. We expect that women will share this same benefit because the combination of high triglycerides and low HDL appears to be a more important risk for heart disease in women. Niacin reduces triglycerides and raises HDL. We also expect to see improvement in markers of inflammation and clot formation and blood vessel health, which we hypothesize should all confer a reduced risk of heart disease in women. Women already taking lipid lowering statin will receive niacin therapy. We will measure blood lipid levels, markers of inflammation and clotting as well as a non-invasive measure of blood vessel reactivity. After 3 months of therapy we will repeat these measures.
Interventions
DRUGNiaspan
1500 mg Niaspan for 16 weeks
Sponsors
General Clinical Research Center (GCRC)
Kos Pharmaceuticals
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Stable women on statin therapy with LDL-C between 90-135mg/dl and triglycerides \> 150mg/dl
Exclusion criteria
* History of MI, PTCA or surgery within previous 3 months * Currently on Niaspan and unwilling to withdraw Niaspan therapy or known intolerance to niacin * Active or known gall bladder disease * Pregnant or nursing women * Significant comorbidity that precludes participation * Significant liver disease, active alcoholism, or LFT \>1.5x's ULN at screening * Diabetes or glucose \> 126 mg/dl at screening * PI perceived inability to comply with protocol
Countries
United States
Outcome results
None listed