Study of the Arachidonate 5-Lipoxygenase Enzyme in Affecting the Risk for Coronary Heart Disease
Overview[ - collapse ][ - ]
| Purpose | 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. |
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| Condition | Coronary Heart Disease |
| Intervention | Drug: montelukast Drug: Placebo |
| Phase | N/A |
| Sponsor | University of Florida |
| Responsible Party | University of Florida |
| ClinicalTrials.gov Identifier | NCT00379808 |
| First Received | September 20, 2006 |
| Last Updated | June 7, 2012 |
| Last verified | June 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 20, 2006 |
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| Last Updated Date | June 7, 2012 |
| Start Date | July 2006 |
| Estimated Primary Completion Date | August 2009 |
| Current Primary Outcome Measures | High-sensitivity C-reactive Protein [Time Frame: 1 month] [Designated as safety issue: No]measured in a CLIA clinical laboratory facility (Quest Diagnostics, Tampa, FL) |
| Current Secondary Outcome Measures | High Density Lipoprotein (HDL)-Cholesterol [Time Frame: 1 month] [Designated as safety issue: No]Lipid levels were determined at a clinical laboratory (Quest Diagnostics) |
Descriptive Information[ + expand ][ + ]
| Brief Title | Study of the Arachidonate 5-Lipoxygenase Enzyme in Affecting the Risk for Coronary Heart Disease |
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| Official Title | Role of the Arachidonate 5-Lipoxygenase Pathway in Coronary Heart Disease |
| 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. |
| 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. |
| Study Type | Interventional |
| Study Phase | N/A |
| Study Design | Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment |
| Condition | Coronary Heart Disease |
| Intervention | Drug: montelukast 10 mg tablet (masked by capsule) daily for 1 month Other Names: SingulairDrug: Placebo 1 lactose-containing capsule daily for 1 month |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 22 |
| Estimated Completion Date | August 2009 |
| Estimated Primary Completion Date | July 2009 |
| Eligibility Criteria | 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00379808 |
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| Other Study ID Numbers | 06011312 |
| Has Data Monitoring Committee | No |
| Information Provided By | University of Florida |
| Study Sponsor | University of Florida |
| Collaborators | American Heart Association |
| Investigators | Principal Investigator: Julie A Johnson, PharmD University of Florida |
| Verification Date | June 2012 |
Locations[ + expand ][ + ]
| University of Florida Family Practice Medical Group Clinic | Gainesville, Florida, United States, 32601 |
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