Benefit of Elevation of HDL-C on Cardiovascular Outcomes in Women
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Niaspan
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Disease focused on measuring Women with and without CAD
Eligibility Criteria
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
Sites / Locations
- CSMC
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00590629
First Posted
December 26, 2007
Last Updated
September 13, 2011
Sponsor
Cedars-Sinai Medical Center
Collaborators
General Clinical Research Center (GCRC), Kos Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00590629
Brief Title
Benefit of Elevation of HDL-C on Cardiovascular Outcomes in Women
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cedars-Sinai Medical Center
Collaborators
General Clinical Research Center (GCRC), Kos Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Women with and without CAD
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Niaspan
Intervention Description
1500 mg Niaspan for 16 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CSMC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Benefit of Elevation of HDL-C on Cardiovascular Outcomes in Women
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