Benefit of Elevation of HDL-C on Cardiovascular Outcomes in Women
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Cedars-Sinai Medical Center
- Enrollment
- 43
- Locations
- 2
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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