Benefit of Elevation of HDL-C in Women

Phase 4

Completed

• Conditions: Cardiovascular Outcomes
• Interventions: Drug: Placebo; Drug: Niaspan

• Registration Number: NCT01921010
• Lead Sponsor: Cedars-Sinai Medical Center

Brief Summary

The combination of HDL-C elevation, lowering of triglycerides and further LDL-C reduction accomplished by the addition of niacin to statin medication would improve endothelial function as compared to LDL-C reduction alone in patients with and without coronary artery disease and the combination of low HDL-C/high triglycerides.

The combination of lipid lowering therapy would have beneficial effects on markers of inflammation. These benefits would be particularly evident in women.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Study First Submitted: 2013-08-09
• Study First Submitted QC: 2013-08-12
• Study First Posted: 2013-08-13
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-22
• Last Update Posted: 2019-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 43

Inclusion Criteria

• Stable CAD(coronary artery disease) patients on statin therapy with LDL-C between 90-135mg/dl and triglycerides > 150mg/dl
• Well-controlled diabetes with HbA1C < 7.5 currently on statin therapy, able to tolerate Niacin without unstable blood glucose levels with LDL-C between 90-135mg/dl and triglycerides > 150mg/dl
• Stable patients on statin therapy with LDL-C between 90-135mg/dl and triglycerides > 150mg/dl

Exclusion Criteria

• History of MI(myocardial infarction), PTCA(percutaneous transluminal coronary angiography) 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(liver function test) >1.5x's ULN( upper limit of normal) at screening
• Diabetes with Hg A1C(hemoglobin A1c) < 7.5
• PI perceived inability to comply with protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	patients will be randomized to placebo 1.5 g/d in addition to usual care statin lipid lowering agents. The dose of placebo will be titrated over a 4-week period and then patients will remain on study drug for additional 12 weeks. The dose of statin will be adjusted in a blinded fashion in both groups at week 10 to similarly achieve a LDL-C of less than 100mg/dl.
Niaspan	Niaspan	Patients will be randomized to Niaspan 1.5 g/d in addition to usual care statin lipid lowering agents. The dose of Niaspan will be titrated over a 4-week period and then patients will remain on study drug for additional 12 weeks. The dose of statin will be adjusted in a blinded fashion in both groups at week 10 to similarly achieve a LDL-C of less than 100mg/dl.

Primary Outcome Measures

Name	Time	Method
endothelial function	16 weeks

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States