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

Coronary Artery Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00590629
• Other study ID #: HDL3954
• Secondary ID: GCRC: Grant #MO1
• Status: Completed
• Phase: Phase 4
• First received: December 26, 2007
• Last updated: September 13, 2011
• Start date: June 2002
• Est. completion date: November 2005

Study information

• Verified date: December 2007
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00192010

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Niaspan
1500 mg Niaspan for 16 weeks

Locations

Country	Name	City	State
United States	CSMC	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	General Clinical Research Center (GCRC), Kos Pharmaceuticals

Country where clinical trial is conducted

United States,