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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

CSMC

Los Angeles, California, 90048, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Niaspan

Drug

1500 mg Niaspan for 16 weeks

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Collaborators

General Clinical Research Center (GCRC)
Kos Pharmaceuticals

Registry information

Important dates

Study start: 2002
Primary completion: 2005
Study completion: 2005
First posted: Jan 10, 2008
Registry last updated: Sep 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed