A double blind, randomized study to compare influence of niacin/laropiprant on functional and morphological characteristics of arterial wall and parameters of inflammation in subjects with CHD already treated with a stati

• Conditions: To evaluate the influence of 12 weeks of ER niacin/laropiprant therapy on endothelial dependent dilatation of the arterial wall in CHD patients already treated with a statin compared to placebo as well as the influence on serum lipids and the parameters of inflammation (TC, LDL, HDL, Tg, NonLDL C, Lp a, CRP, IL-6, TNF-a, TFPI, PAI-1 antigen and activity, t-PA antigen and activity ) in CHD patients already treated with a statin compared to placebo.

• Registration Number: EUCTR2009-017622-39-SI
• Lead Sponsor: Clinical Center Ljubljana

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 62

Inclusion Criteria

-age 35-55, with
-confirmed CHD (post MI patients, coronarography and/or cycloergometry)
-already treated for dyslipidemia with a statin and reaching ESC LDL target
-HDL-C <1.1 mmol/l, TG > 1,7 mmol/l and LDL < 2,6 mmol/L

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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-3x increase of liver enzyme tests or CK
-severe renal insufficiency – creatinin >200 mmol/l,
-acute disease within 6 weeks prior to inclusion,
-hypersensitivity to nicotinic acid
-other cardiac medication stable for at least 4 weeks prior to enrollment
-Acute MI, CABG, PCI within past 3 months.
-Congestive heart failure (CHF) _ NYHA 2.
-Ejection fraction < 40% measured within the past 6 months.
-Malignancy.
-HIV infection or immunodeficiency state.
-Stable dose of statin < 6 weeks
-Diabetes mellitus type 1.
-Diabetes mellitus type 2 with HbA1C > 7%
-Hypo/hyper thyroidism.
-Alcohol or drug abuse

Study & Design

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