Ignite Creation Date:
2024-05-05 @ 11:58 PM
Last Modification Date:
2024-10-26 @ 10:42 AM
Study NCT ID:
NCT01450410
Status:
TERMINATED
Last Update Posted:
2013-01-29
First Post:
2011-10-07
Brief Title:
Nicotinic Acid Composition of HDL and Arterial Endothelium Function in Premature Coronary Heart Disease and High HDL
Sponsor:
Xavier Pinto Sala
Organization:
Hospital Universitari de Bellvitge
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated halted prematurely as recomended by the drug supplier and medical agencies
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
11MSP011
Brief 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 NALaropiprant 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 20mmolL in females and 18mmolL in males and an LDL-C 100mgdL 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
Objectives To analyse if the treatment with nicotinic acid NALaropiprant 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 20mmolL in females and 18mmolL in males and an LDL-C 100mgdL 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None