Benefit of Elevation of HDL-C in Women

Sponsor

Cedars-Sinai Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01921010

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Outcomes	Drug: Niaspan Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

43 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Benefit of Elevation of HDL-cholesterol/Triglyceride Lowering on Cardiovascular Outcomes in Women

Study Start Date :

Jun 1, 2003

Actual Primary Completion Date :

Jun 1, 2005

Actual Study Completion Date :

Jun 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Niaspan See Arm Description
Placebo Comparator: 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.	Drug: Placebo See Arm Description

Arm

Intervention/Treatment

Active Comparator: 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.

Drug: Niaspan

See Arm Description

Placebo Comparator: 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.

Drug: Placebo

See Arm Description

Outcome Measures

Primary Outcome Measures

endothelial function [16 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048

Sponsors and Collaborators

Cedars-Sinai Medical Center

Investigators

Principal Investigator: C. Noel Bairey Merz, M.D., Cedars-Sinai Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Noel Bairey Merz, Director, Cedars-Sinai Medical Center

ClinicalTrials.gov Identifier:

NCT01921010

Other Study ID Numbers:

3954

First Posted:

Aug 13, 2013

Last Update Posted:

Apr 23, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Additional relevant MeSH terms:

Niacin

Nicotinic Acids

Study Results

No Results Posted as of Apr 23, 2019