Impact of 12 weeks oral niacin on endothelial function, lipid composition and cardiovascular biomarkers in patients with coronary artery disease: a prospective, randomized, double-blind, placebo-controlled, monocentric clinical trial of phase IV

Completed

• Conditions: Coronary artery disease (CAD) and known dyslipidemia; Circulatory System

• Registration Number: ISRCTN48365122
• Lead Sponsor: Johannes Gutenberg-University Mainz (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-20
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Men or women > 35 and < 80 years of age
2. Documented clinically stable CAD and known dyslipidemia, defined by a low-density lipoprotein cholesterol (LDL >70 mg/dl) and a high density lipoprotein cholesterol (HDL <65mg/dl)
3. A flow-mediated vasodilatation (FMD) of less than 8%
4. Ability of subject to understand character and individual consequences of clinical trial
5. Written informed consent must be available before enrolment in the trial
6. For women with childbearing potential, adequate contraception

Exclusion Criteria

1. Clinical signs of congestive heart failure or left ventricular ejection fraction <30%
2. Uncontrolled hypertension (blood pressure >180/110mmHg) or hypotension (systolic blood pressure <90 mmHg)
3. Initiation of any of the following medications within the last twelve weeks: aspirin, lipid-lowering agents, calcium antagonists, betablockers, angiotensin converting enzymes inhibitors (ACEI) or angiotensin ?1 (AT1) receptor blockers, hormone replacement therapy
4. Use of steroids or chemotherapy drugs within the past year or chronic use of non-steroidal anti-inflammatory drugs except for aspirin
5. Hemodynamically significant valvular heart diseases or hypertrophic obstructive cardiomyopathy
6. Renal dysfunction (creatinine > 2.5 mg/dl)
7. Known hepatic disease or elevation of serum transaminases or gamma glutamyl transferase (gGT) > 2x ULN (upper limit of normal range)
8. Uric acid >10.0 mg/dl
9. Alcohol abuse
10. White blood cell (WBC) count >12,000 or platelet count >500,000 /ul or <75,000 /ul
11. Existence of acute gastric ulcers
12. Existence of acute arterial bleeding
13. Other significant laboratory abnormalities

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effect of 12 weeks oral niacin therapy in addition to standard long-term CAD medication on flow dependent vasodilation (FMD) in patients suffering from CAD

Secondary Outcome Measures

Name	Time	Method
Effects of niacin therapy on plasma lipid composition, HDL-C levels, LDL, triglycerides, total cholesterol, cholesterol ratio, high sensitivity C-reactive protein (hs-CRP), cardiovascular biomarkers, endothelium-independent nitrogylcerin-induced vasodilation (NMD) and FMD levels.