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Aspirin Dose and Atherosclerosis in Patients With Metabolic Syndrome - Article


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Atherosclerosis

Arteriosclerosis; Arteriosclerosis/Atherosclerosis


Clinical Trial: Aspirin Dose and Atherosclerosis in Patients With Metabolic Syndrome

This study is not yet open for patient recruitment.
Verified by Florida Atlantic University October 2005

Sponsors and Collaborators: Florida Atlantic University
Bayer Corporation
Information provided by: Florida Atlantic University
ClinicalTrials.gov Identifier: NCT00272311

Purpose

The purpose of the study is to test higher versus lower doses of aspirin on markers of atherosclerosis in patients at risk of a first heart attack.
Condition Intervention Phase
Cardiovascular Diseases
Metabolic Syndrome X
Atherosclerosis
 Drug: Aspirin
Phase IV

MedlinePlus related topics:  Heart Diseases;   Metabolic Syndrome X;   Vascular Diseases

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Official Title: A Randomized, Double-Blind Trial to Test Higher- Versus Lower-Doses of Aspirin on Inflammatory Markers and Platelet Biomarkers and Nitric Oxide Formation in High Risk Primary Prevention (Patients With Metabolic Syndrome)

Further study details as provided by Florida Atlantic University:
Primary Outcomes: inflammatory markers, measured at baseline and 3 months; platelet biomarkers, measured at baseline and 3 months; nitric oxide formation, measured at baseline and 3 months
Expected Total Enrollment:  100

Study start: January 2006

Aspirin reduces risks of heart attacks, strokes, and deaths from cardiovascular causes in patients who have survived a prior event as well as during an acute heart attack. Aspirin also prevents a first heart attack.

Low dose aspirin is sufficient to achieve complete inhibition of platelet aggregability, or stickiness, and this is the mechanism whereby aspirin prevents formation of blood clots.

Our research is designed to explore whether higher doses of aspirin provide additional benefits on markers of atherosclerosis.

Eligibility

Ages Eligible for Study:  40 Years   -   75 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • 1. Age 40 to 75 years, inclusive.

    2. No previous heart attack or a stroke, or other forms of these diseases.

    3. Have at least three of the five characteristics listed below, indicating presence of metabolic syndrome, as defined by NCEP-III:

    1. waist measuring more than 40 inches (for men) or more than 35 inches (for women),
    2. high density lipoprotein (HDL) cholesterol levels lower than 40 milligrams per deciliter (mg/dl) in men or 50 mg/dl in women,
    3. triglyceride (TG) levels above 150 mg/dl,
    4. blood pressure greater than 130 millimeters of mercury (mmHg) systolic or 85 mmHg diastolic,
    5. fasting blood sugar greater than 110 mg/dl

      Exclusion Criteria:

  • 1. Patients taking anti-platelet drugs such as clopidogrel or non-steroidal anti-inflammatory drugs (NSAIDs) or anticoagulant drugs such as warfarin, during the last two weeks.

    2. Patients who are currently cigarette smokers.

    3. Women patients who are pregnant, planning to become pregnant, nursing a child, or taking hormone replacement therapy.

    4. Patients with any coagulation, bleeding or blood disorders.

    5. Patients who are sensitive or allergic to aspirin.

    6. Patients with documented history of any gastrointestinal disorders, including bleeding ulcers.

    7. Patients with any evidence of cancer or history of significant cardiovascular disease (including heart attack, stroke or drop attacks termed transient ischemic attacks (TIAs), or blockages of the arteries in the legs termed peripheral arterial disease (PAD)), kidney, liver, lung, blood, or brain disorders.

    8. Patients with asthma, rhinitis, or nasal polyps.

    9. Patients with any abnormal laboratory value or physical finding that, in the view of the responsible clinician, may interfere with interpretation of the study results, be indicative of an underlying disease state, or compromise the safety.

    10. Patients with hearing loss or tinnitus.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00272311

Danielle Hollar, PhD      561-297-6984    hollard@fau.edu
Charles H Hennekens, MD, DrPH       chenneke@fau.edu

Maryland
      HeartDrug Research, LLC, Towson,  Maryland,  21204,  United States
Victor L Serebruany, MD, PhD  410-847-9491    heartdrug@aol.com 
Victor L Serebruany, MD, PhD,  Principal Investigator

Study chairs or principal investigators

Charles H Hennekens, MD, DrPH,  Principal Investigator,  Florida Atlantic University   
Danielle Hollar, PhD,  Study Director,  Florida Atlantic University   

More Information

Study ID Numbers:  H04-260
Last Updated:  January 4, 2006
Record first received:  January 3, 2006
ClinicalTrials.gov Identifier:  NCT00272311
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2006-01-10


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Page Updated: December 9, 2005
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