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Nicotinic Acid Composition of HDL and Arterial Endothelium Function in Premature Coronary Heart Disease and High HDL (11MSP011)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Xavier Pinto Sala, Hospital Universitari de Bellvitge

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 (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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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 Drug: Placebo
Placebo treatment will last for 12 weeks.
Other Name: Control

Primary Outcome Measures :
  1. Apo A1 of HDL [ Time Frame: Baseline; 12 weeks ]
    The amount of Apo A1 as a marker of HDL composition.

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Being male or female
  • Age > 25 years
  • Have an episode of ischemic heart disease before 55 years in men and in women 65 years
  • Serum HDL-C above the 90th percentile of the Spanish population: >=2.0mmol/L in women and >=1.8mmol/L in men (Gomez-Gerique JA, et al. Med Clin (Barc.). 1999, 113: 730-735.)
  • Stable treatment with any statin in the past 6 weeks: simvastatin, atorvastatin, rosuvastatin, pravastatin or lovastatin.

Exclusion Criteria:

  • Uncontrolled hypercholesterolemia or hypertriglyceridemia, LDL-C >2.6mmol/L or triglycerides >2.24mmol/L
  • Patients with an episode of ischemic heart disease in the last 3 months
  • Patients suffering from acute or chronic inflammatory diseases in the last 3 months
  • Treatment with fibrates or omega-3 fatty acids.
  • Treatment with steroids or immunosuppressive drugs
  • Patients with a contraindication to Tredaptive (Hypersensitivity to the active substances or any of the excipients, significant or unexplained hepatic dysfunction, active peptic ulcer, arterial bleeding).
  • Patients treated with drugs that may interact with Tredaptive (Midazolam).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01450410

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Unitat Funcional de Risc Vascular. Servei Medicina Interna. Hospital Universitari de Bellvitge.
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Sponsors and Collaborators
Xavier Pinto Sala
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Principal Investigator: Xavier Pintó, PhD Hospital Universitari de Bellvitge
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Responsible Party: Xavier Pinto Sala, Principal Investigator, Hospital Universitari de Bellvitge Identifier: NCT01450410    
Other Study ID Numbers: CompHDL2011
First Posted: October 12, 2011    Key Record Dates
Last Update Posted: January 29, 2013
Last Verified: November 2011
Keywords provided by Xavier Pinto Sala, Hospital Universitari de Bellvitge:
Dyslipemia, HDL composition
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases
Nicotinic Acids
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents