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

Sponsor
Xavier Pinto Sala (Other)
Overall Status
Terminated
CT.gov ID
NCT01450410
Collaborator
(none)
12
Enrollment
1
Location
2
Arms
10
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Nicotinic acid
  • Drug: Placebo
 Phase 4

Study Design

Study Type:
Interventional
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 :
Jul 1, 2012
Anticipated Primary Completion Date :
Mar 1, 2013
Anticipated Study Completion Date :
May 1, 2013

Arms and Interventions

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 Names:
  • Tredaptive

    		•
    Placebo Comparator: Placebo

    Drug: Placebo
    Placebo treatment will last for 12 weeks.
    Other Names:
  • Control

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Apo A1 of HDL [Baseline; 12 weeks]

      The amount of Apo A1 as a marker of HDL composition.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years and Older
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Investigators

    • Principal Investigator: Xavier Pintó, PhD, Hospital Universitari de Bellvitge

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xavier Pinto Sala, Principal Investigator, Hospital Universitari de Bellvitge
    ClinicalTrials.gov Identifier:
    NCT01450410
    Other Study ID Numbers:
    • CompHDL2011
    First Posted:
    Oct 12, 2011
    Last Update Posted:
    Jan 29, 2013
    Last Verified:
    Nov 1, 2011
    Keywords provided by Xavier Pinto Sala, Principal Investigator, Hospital Universitari de Bellvitge
    Dyslipemia, HDL composition
    Additional relevant MeSH terms:
    Dyslipidemias
    Nicotinic Acids
    Niacin
    Niacinamide

    Study Results

    No Results Posted as of Jan 29, 2013