Benefit of Elevation of HDL-C on Cardiovascular Outcomes in Women

Completed · Phase 4

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT00590629

Run by

Cedars-Sinai Medical Center

People needed

43

Starts

2002-06-01

Expected to finish

2005-11-01

Last updated by the study team

2011-09-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Stable women on statin therapy with LDL-C between 90-135mg/dl and triglycerides > 150mg/dl

You may not qualify if…

• 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

Where it is running

• CSMC — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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