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.
Conditions
Interventions
Trade Name: Tredaptive
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Clinical Center Ljubljana
Eligibility
Sex/Gender
Male
Inclusion criteria
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 1,7 mmol/l and LDL =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 7% - Hypo/hyper thyroidism. - Alcohol or drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: Secondary objective: To evaluate the influence of 12 weeks of ER niacin/laropiprant therapy 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. ;Primary end point(s): I. In patients with CHD ER niacin/laropiprant therapy will cause statistically significant improvement of endothelial dependent dilatation of the arterial wall after 12 weeks of treatment compared to placebo. II. In patients with CHD ER niacin/laropiprant (2 g) daily will be superior to placebo at 12 weeks at increasing HDL-C, decreasing triglycerides, decreasing TC/HDL-C ratio, decreasing LDL-C/HDL-C ratio, decreasing Apo B, increasing Apo A-1 | — |
Countries
Slovenia
Outcome results
None listed