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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2005-11-30

Brief Summary

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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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Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Niaspan

1500 mg Niaspan for 16 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No