Nicotinic Acid Composition of HDL and Arterial Endothelium Function in Premature Coronary Heart Disease and High HDL (11MSP011)
|ClinicalTrials.gov Identifier: NCT01450410|
Recruitment Status : Terminated (Study terminated (halted prematurely) as recomended by the drug supplier and medical agencies)
First Posted : October 12, 2011
Last Update Posted : January 29, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Dyslipidemias||Drug: Nicotinic acid Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efecto Del ácido nicotínico Sobre la composición de Las lipoproteínas de Alta Densidad (HDL) y la función Del Endotelio Arterial en Los Pacientes Con cardiopatía isquémica Prematura y Concentraciones Elevadas de Colesterol-HDL|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||March 2013|
|Estimated Study Completion Date :||May 2013|
|Active Comparator: Nicotinic Acid||
Drug: Nicotinic acid
Nicotinic acid / laropiprant (Tredaptive 1000 mg/20 mg modified-release tablets). Patients treated with nicotinic acid 1g/day receive one dose of one month and 2 g / day thereafter. Nicotinic acid treatment will last for 12 weeks.
Other Name: Tredaptive
|Placebo Comparator: Placebo||
Placebo treatment will last for 12 weeks.
Other Name: Control
- Apo A1 of HDL [ Time Frame: Baseline; 12 weeks ]The amount of Apo A1 as a marker of HDL composition.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01450410
|Unitat Funcional de Risc Vascular. Servei Medicina Interna. Hospital Universitari de Bellvitge.|
|L'Hospitalet de Llobregat, Barcelona, Spain, 08907|
|Principal Investigator:||Xavier Pintó, PhD||Hospital Universitari de Bellvitge|