Benefit of Elevation of HDL-C on Cardiovascular Outcomes in Women
2 other identifiers
interventional
43
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 coronary-artery-disease
Started Jun 2002
Typical duration for phase_4 coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 26, 2007
CompletedFirst Posted
Study publicly available on registry
January 10, 2008
CompletedSeptember 14, 2011
December 1, 2007
3.4 years
December 26, 2007
September 13, 2011
Conditions
Keywords
Interventions
1500 mg Niaspan for 16 weeks
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cedars-Sinai Medical Centerlead
- General Clinical Research Center (GCRC)collaborator
- Kos Pharmaceuticalscollaborator
Study Sites (1)
CSMC
Los Angeles, California, 90048, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 26, 2007
First Posted
January 10, 2008
Study Start
June 1, 2002
Primary Completion
November 1, 2005
Study Completion
November 1, 2005
Last Updated
September 14, 2011
Record last verified: 2007-12