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Study of the Arachidonate 5-Lipoxygenase Enzyme in Affecting the Risk for Coronary Heart Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00379808
Recruitment Status : Completed
First Posted : September 22, 2006
Results First Posted : July 23, 2012
Last Update Posted : July 23, 2012
American Heart Association
Information provided by (Responsible Party):
University of Florida

Brief Summary:
The purpose of this study is to determine whether a particular substance involved in inflammation, called leukotrienes, is involved in causing heart disease to occur or to progress.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Drug: montelukast Drug: Placebo Not Applicable

Detailed Description:
The focus of this study is to better understand why some adults develop heart disease and others do not. There are many known factors which play a role in causing heart disease, such as diet and lifestyle. Also, we know that inflammation, a process in the body which causes painful joints in arthritis or swelling at a site if injury, also contributes to heart disease. In particular, we will address whether leukotrienes, a component of inflammation, is involved in promoting heart disease. We will study this by giving subjects at high risk for heart disease a drug called montelukast which causes leukotrienes to have a reduced effect in the body. In addition for comparison, we will give other subjects a placebo for the same amount of time. These subjects will then be crossed-over and will receive either montelukast or placebo depending on which treatment they received first. We will compare these subjects using blood tests to see if subjects who take montelukast show signs of less inflammation caused by early heart disease as compared to subjects who do not.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Role of the Arachidonate 5-Lipoxygenase Pathway in Coronary Heart Disease
Study Start Date : July 2006
Actual Primary Completion Date : July 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Montelukast

Arm Intervention/treatment
Placebo Comparator: Placebo
1 lactose-containing capsule daily for 1 month
Drug: Placebo
1 lactose-containing capsule daily for 1 month

Active Comparator: Montelukast 10 mg
1 montelukast 10 mg tablet (masked by capsule) daily for 1 month
Drug: montelukast
10 mg tablet (masked by capsule) daily for 1 month
Other Name: Singulair

Primary Outcome Measures :
  1. High-sensitivity C-reactive Protein [ Time Frame: 1 month ]
    measured in a CLIA clinical laboratory facility (Quest Diagnostics, Tampa, FL)

Secondary Outcome Measures :
  1. High Density Lipoprotein (HDL)-Cholesterol [ Time Frame: 1 month ]
    Lipid levels were determined at a clinical laboratory (Quest Diagnostics)

Other Outcome Measures:
  1. Triglycerides [ Time Frame: 1 month ]
    measured by a clinical laboratory; Quest Laboratories

  2. Monocyte Chemotactic Protein-1 (MCP-1) [ Time Frame: 1 month ]
    biomarker was measured by enzyme-linked immunosorbant assay (ELISA)

  3. Interleukin 1 Receptor Antagonist (IL1ra) [ Time Frame: 1 month ]
    IL1ra was determined by enzyme-linked immunosorbant assay (ELISA)

  4. Epithelial Cell-derived Neutrophil-activating Peptide 78 (ENA-78) [ Time Frame: 1 month ]
    biomarker determined by enzyme-linked immunosorbant assay.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

-Current hypertension (blood pressure > 140/90 mmHg) or current use of anti-hypertensive medications AND

Exclusion Criteria:

  • Current use of lipid-lowering medications
  • Current use of montelukast
  • Poorly controlled hypertension, where systolic blood pressure is greater than 160 or diastolic blood pressure is greater than 100
  • Use of steroid drugs, non-steroidal anti-inflammatory drugs or other anti-inflammatory medications in the two weeks prior to enrollment. (low dose aspirin ( < 325 mg) is OK, but indication must be cardiovascular)
  • Current recreational drug use
  • Other cardiovascular disease or previous cardiovascular event. These include:
  • history of angina pectoris
  • history of heart failure
  • presence of a cardiac pacemaker
  • history of myocardial infarction
  • previous revascularization procedure
  • history cerebrovascular disease including stroke and transient ischemic attack
  • Pregnancy or lactation
  • Diabetes mellitus
  • Lactose intolerance
  • Contraindications to montelukast therapy
  • Alcoholism
  • Known hepatic disease
  • Existing chronic obstructive pulmonary disease, asthma, allergic rhinitis
  • Active chronic immune, infectious, neoplastic or inflammatory diseases requiring therapy (such as active Hepatitis B, Hepatitis C, human immunodeficiency virus (HIV))
  • Immunosuppressant therapy or known immunosuppression due to disease high density lipoprotein (HDL) < 40 mg/dL (although this would be a risk factor for heart disease, because of preliminary data which indicates that montelukast may lower HDL levels, we will exclude patients with abnormally low HDL from study)
  • Other criteria at investigator discretion that are deemed to make the subject a poor candidate for the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00379808

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United States, Florida
University of Florida Family Practice Medical Group Clinic
Gainesville, Florida, United States, 32601
Sponsors and Collaborators
University of Florida
American Heart Association
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Principal Investigator: Julie A Johnson, PharmD University of Florida
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Responsible Party: University of Florida Identifier: NCT00379808    
Other Study ID Numbers: 06011312
AHA0615253B ( Other Grant/Funding Number: American Heart Associatino )
First Posted: September 22, 2006    Key Record Dates
Results First Posted: July 23, 2012
Last Update Posted: July 23, 2012
Last Verified: June 2012
Keywords provided by University of Florida:
coronary heart disease
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action