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

This study has been terminated.
(Study terminated (halted prematurely) as recomended by the drug supplier and medical agencies)
Sponsor:
Information provided by (Responsible Party):
Xavier Pinto Sala, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier:
NCT01450410
First received: October 7, 2011
Last updated: January 28, 2013
Last verified: November 2011
  Purpose

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 Intervention Phase
Dyslipidemias
Drug: Nicotinic acid
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Hospital Universitari de Bellvitge:

Primary Outcome Measures:
  • Apo A1 of HDL [ Time Frame: Baseline; 12 weeks ] [ Designated as safety issue: No ]
    The amount of Apo A1 as a marker of HDL composition.


Enrollment: 12
Study Start Date: July 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450410

Locations
Spain
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
  More Information

No publications provided

Responsible Party: Xavier Pinto Sala, Principal Investigator, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT01450410     History of Changes
Other Study ID Numbers: CompHDL2011
Study First Received: October 7, 2011
Last Updated: January 28, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Hospital Universitari de Bellvitge:
Dyslipemia, HDL composition

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Niacin
Niacinamide
Nicotinic Acids
Antimetabolites
Cardiovascular Agents
Growth Substances
Hypolipidemic Agents
Lipid Regulating Agents
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on November 24, 2014