Benefit of Elevation of HDL-C in Women

NCT ID: NCT01921010

Last Updated: 2019-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2005-06-30

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.

Conditions

Cardiovascular Outcomes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Niaspan

Intervention Type: DRUG

See Arm Description

Control

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

See Arm Description

Interventions

Niaspan

See Arm Description

Intervention Type: DRUG

Placebo

See Arm Description

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Noel Bairey Merz

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

C. Noel Bairey Merz, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

3954

Identifier Type: -

Identifier Source: org_study_id