Impact of 12 weeks of 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 - INEF

• Conditions: Women or men > 35 and < 80 years of age with a documented, clinically stable coronary artery disease (CAD) and a flow-mediated vasodilatation (FMD) of less than 8% from the heart catheter register of the department of medicine II, Johannes Gutenberg-University Mainz.

• Registration Number: EUCTR2005-005347-25-DE
• Lead Sponsor: Johannes Gutenberg-Universität Mainz, II. Med. Klinik (ausführende Stelle), Prof. Dr. med. T. Münzel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Clinical signs of congestive heart failure or left ventricular ejection fraction <30%
-Uncontrolled hypertension (blood pressure >180/110mmHg) or hypotension (systolic blood pressure <90 mmHg)
-Initiation of any of the following medications within the last twelve weeks: Aspirin, lipid-lowering agents; calcium antagonists;betablockers, ACE-inhibitors or AT1 receptor blockers; hormone replacement therapy
-Use of steroids or chemotherapy drugs within the past year or chronic use of nonsteroidal anti-inflammatory drugs except of aspirin
-Hemodynamically significant valvular heart disease or hypertrophic obstructive cardiomyopathy
-Renal dysfunction (creatinine > 2.5 mg/dl)
-Known hepatic disease or elevation of serum transaminases or gGT > 2x ULN (upper limit of normal range)
-Uric acid >10,0 mg/dl
-Alcohol abuse
-WBC >12.000 or platelet count >500.000/µl or <75.000/µl
-Existence of acute gastric ulcers
-Existence of acute arterial bleeding
-Other significant laboratory abnormalities that the investigator feels may compromise the patient’s safety by participation in the study
-History of systemic inflammatory disease (rheumatoid arthritis, osteoarthritis, inflammatory bowel disease, systemic lupus erythematous), myositis/myopathic process, or cancer
-Known HIV
-Malabsorption
-Overt hyperthyreodism
-Pregnancy and lactation
-History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
-Participation in other clinical trials and observation period of competing trials, respectively

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Effect of an 12 weeks oral niacin therapy in addition to standard long-term CAD medication on flow dependent vasodilation (FMD) in patients.<br>;Secondary Objective: Effects of niacin therapy on plasma lipid composition, HDL-C levels, LDL, trigylcerides, total cholesterol, cholesterol ratio, hs-CRP, cardiovascular biomarkers, endothelium-independent nitroglycerin-induced vasodilation (NMD) and FMD levels.<br>;Primary end point(s): Primary endpoint is the absolute change in FMD from baseline to 12 weeks-follow-up.