The Low HDL On Six Weeks Statin Therapy (LOW) Study

NCT00238004 | Unknown Phase 4

• 1 other identifier: 2004-001690-26
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Abnormal blood cholesterol levels increase the risk of developing, or dying from heart disease. It is well recognised that if "harmful" LDL cholesterol is high, and "protective" HDL cholesterol is low, this risk is increased. Drugs called statins are routinely used in patients with heart disease, are well tolerated, and decrease the harmful LDL cholesterol levels. However, statins only increase protective HDL cholesterol to a small extent. Some patients may thus benefit from additional medication to increase protective HDL-cholesterol further. One of the most effective drugs which can do this is nicotinic acid. This drug is well established having been available for over 30 years. Previous use has been limited by facial flushing in a large percentage of patients receiving the drug. However a new formulation called Niaspan is now available which is associated with much less flushing. Although many patients will have transient flushing, it is estimated that only 1 patient out of every 20 receiving the drug will have to discontinue treatment. We therefore propose, in patients with coronary artery disease and low HDL cholesterol despite being on a statin, to study the effect of Niaspan on HDL cholesterol and other lipid parameters, and to assess its tolerability.

Conditions

HDL Cholesterol; Coronary Arteriosclerosis; Lipoproteins

Keywords

Niacin

Outcome Measures

Primary Outcomes (1)

• Number of patients achieving target HDL-C levels (defined as HDL-C >1.0mmol/l in males or >1.29mmol/l in females) after completion of the study protocol

Secondary Outcomes (1)

• Incidence and severity of flushing

Interventions

Nicotinic acid DRUG

Eligibility Criteria

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

You may qualify if:

• Persisting low HDL-C (\<0.9mmol/l) on a full lipid profile result (which for inpatients should have been taken \<24 hours after admission).
• Objective diagnosis of coronary heart disease (previous biomarker proven MI, positive stress test, angiogram with at least one \>50% diameter stenosis)
• Established for at least 6 weeks on a "maintenance" dose of statin therapy (defined as Pravastatin 40mg, Simvastatin 40mg or Atorvastatin ≥10mg). The dose and type of statin should not be altered during the study period
• Absence of concurrent major systemic illness (particularly liver or renal failure, or hypo or hyperthyroidism)

You may not qualify if:

• Previous use of Niaspan or other non-statin lipid lowering agent within the previous 12 weeks
• Contraindications to Niaspan therapy
• Participation in another medical trial within the previous 30days
• Failure to obtain informed consent

Sponsors & Collaborators

• Craigavon Area Hospital: lead

Study Sites (1)

Craigavon Cardiac Centre

Craigavon, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Niacin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• I Menown, MD FRCP

  Craigavon Area Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 12, 2005
• First Posted: October 13, 2005
• Study Start: November 1, 2005
• Last Updated: September 13, 2006

Record last verified: 2006-09

Locations

GB (1)