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

January 28, 2013 updated by: Xavier Pinto Sala

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

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.

Study Overview

Status

Terminated

Conditions

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Unitat Funcional de Risc Vascular. Servei Medicina Interna. Hospital Universitari de Bellvitge.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo treatment will last for 12 weeks.
Other Names:
  • Control
Active Comparator: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apo A1 of HDL
Time Frame: Baseline; 12 weeks
The amount of Apo A1 as a marker of HDL composition.
Baseline; 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Anticipated)

May 1, 2013

Study Registration Dates

First Submitted

October 7, 2011

First Submitted That Met QC Criteria

October 11, 2011

First Posted (Estimate)

October 12, 2011

Study Record Updates

Last Update Posted (Estimate)

January 29, 2013

Last Update Submitted That Met QC Criteria

January 28, 2013

Last Verified

November 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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