High-Density Lipoprotein (HDL) Modulation and Endothelial Function

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

It is well known that lowering low-density lipoprotein (LDL) (bad cholesterol) is beneficial for decreasing heart attacks and death. More recently, focus has been on trying to raise HDL (good) cholesterol. The purpose of the present study is to determine if the addition of a sustained release preparation of niacin (Niaspan - a medicine to raise HDL cholesterol) to LDL lowering with a statin type medication results in improved vascular health. The study of the well being of one's vessel wall (endothelial function) will serve as a marker of treatment effect in the study.

Hypotheses: Extended-release (ER) niacin will improve endothelial function measured as brachial flow-mediated dilation (FMD - 10 end-point) and as pulse volume amplitude by pulse arterial tonometry (PAT) (20 end-point) in subjects with established atherosclerosis whose LDL cholesterol is optimally treated with statin therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Calgary
• Collaborator: Heart and Stroke Foundation of Ontario
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

Inclusion Criteria:

• Aged 18-80 years

• Coronary artery disease

Exclusion Criteria:

• HDL > 1.10 (men), > 1.30 (women)

• PCI within 30 days or CABG within 90 days

• Symptomatic congestive heart failure (CHF)

• Uncontrolled hypertension

• Gout or active gallbladder disease, liver disease or peptic ulcer disease

• Diabetes (or if Fasting blood sugar > 7.0 then hemoglobin A1c [HbA1C] > 6.1 is exclusionary)

• Abnormalities of complete blood count (CBC), creatinine or ALT

• Change in endothelial modulating drugs in the last month or use of niacin