Nicotinic Acid Composition of HDL and Arterial Endothelium Function in Premature Coronary Heart Disease and High HDL
Status:
Terminated
Trial end date:
2013-05-01
Target enrollment:
Participant gender:
Summary
Patients with premature ischemic heart disease (PIHD) and elevated levels of HDL-C present an
altered composition of high-density lipoproteins (HDL) which is associated with a loss of
their anti-atherogenic effects and of their arterial endothelium function.
Objectives: To analyse if the treatment with nicotinic acid (NA)/Laropiprant can correct the
alterations of the HDL composition and endothelial function in patients with PIHD and
elevated HDL-C.
Methods: A total of 46 subjects with PIHD who are stable in the 3 months prior to the Study,
who continue in treatment with statins and have elevated concentrations of HDL-C (HDL-C
≥2.0mmol/L in females and ≥1.8mmol/L in males) and an LDL-C <100mg/dL. This is a
double-blind, randomised Study; after 6 weeks of lifestyle stabilisation, the subjects will
be treated with NA or placebo for 16 weeks. At the start and end of treatment, HDL
composition will be studied through density gradient preparative ultracentrifuge separation
and FBLC (fast protein liquid chromatography) and through the changes in vasodilation induced
by the endothelium through ultrasound. Primary endpoint: change in the apoA1 content
associated to treatment. Secondary endpoints: variations in the change of the brachial artery
diameter with reactive hyperaemia and changes in the content of other lipid and protein
components of HDL including apoA2, paraoxonase, amyloid A and LCAT. The changes in HDL
composition and endothelial function will be assessed with an analysis of variance with
repeated measurements and a 2x2 design.