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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Niaspan

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • CSMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Collaborators: Kos Pharmaceuticals; General Clinical Research Center (GCRC)

Study record dates

Study Major Dates

• Study Start: June 1, 2002
• Primary Completion (Actual): November 1, 2005
• Study Completion (Actual): November 1, 2005

Study Registration Dates

• First Submitted: December 26, 2007
• First Submitted That Met QC Criteria: January 9, 2008
• First Posted (Estimate): January 10, 2008

Study Record Updates

• Last Update Posted (Estimate): September 14, 2011
• Last Update Submitted That Met QC Criteria: September 13, 2011
• Last Verified: December 1, 2007

More Information

Terms related to this study

• Keywords: Women with and without CAD
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Antimetabolites; Micronutrients; Hypolipidemic Agents; Lipid Regulating Agents; Vitamins; Vitamin B Complex; Nicotinic Acids; Niacin
• Other Study ID Numbers: HDL3954; GCRC: Grant #MO1-RR00425