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

NCT01450410 | Terminated Phase 4 DMC

• 1 other identifier: CompHDL2011
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyslipidemias

Keywords

Dyslipemia, HDL composition

Outcome Measures

Primary Outcomes (1)

• Apo A1 of HDL

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

  Baseline; 12 weeks

Study Arms (2)

Nicotinic Acid

ACTIVE COMPARATOR

Drug: Nicotinic acid

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Nicotinic acid DRUG

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.

Also known as: Tredaptive

Nicotinic Acid

Placebo DRUG

Placebo treatment will last for 12 weeks.

Also known as: Control

Placebo

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Xavier Pinto Sala: lead

Study Sites (1)

Unitat Funcional de Risc Vascular. Servei Medicina Interna. Hospital Universitari de Bellvitge.

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

Niacin

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Xavier Pintó, PhD

  Hospital Universitari de Bellvitge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 7, 2011
• First Posted: October 12, 2011
• Study Start: July 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: May 1, 2013
• Last Updated: January 29, 2013

Record last verified: 2011-11

Locations

ES (1)