Aspirin Dose and Atherosclerosis in Patients With Metabolic Syndrome (PAD)

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: NCT00272311
Recruitment Status : Completed
First Posted : January 5, 2006
Results First Posted : June 19, 2012
Last Update Posted : June 25, 2012
Information provided by (Responsible Party):
Florida Atlantic University

Brief Summary:
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 or disease Intervention/treatment Phase
Cardiovascular Diseases Metabolic Syndrome X Atherosclerosis Drug: Aspirin Phase 4

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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)
Study Start Date : October 2006
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Arm Intervention/treatment
Active Comparator: 1
81 mg Aspirin
Drug: Aspirin
Active Comparator: 2
162 mg Aspirin
Drug: Aspirin
Active Comparator: 3
325 mg Aspirin
Drug: Aspirin
Active Comparator: 4
650 mg Aspirin
Drug: Aspirin
Active Comparator: 5
1300 mg Aspirin
Drug: Aspirin

Primary Outcome Measures :
  1. Change in Inflammatory Markers From Baseline to 3 Months [ Time Frame: Baseline to 3 Months (90-97 days) ]
  2. Change in Platelet Biomarkers From Baseline to 3 Months [ Time Frame: Baseline to 3 Months (90-97 days) ]
  3. Change in Nitric Oxide Formation From Baseline to 3 Months [ Time Frame: Baseline to 3 Months (90-97 days) ]
    Changes in Heme oxygenase (HO-1) a downstream target of nitric oxide (NO) formation.

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 1. Age 40 to 80 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 greater than 81mg aspirin daily.
  2. 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.
  3. Patients taking any of the following medications for less than 3 months, or who plan to take them for the first time during the next 3 months: ACE-inhibitors, angiotensin receptor blockers, calcium channel blockers, or statins.
  4. Patients who are currently cigarette smokers.
  5. Women patients who are pregnant, planning to become pregnant, nursing a child, or taking hormone replacement therapy.
  6. Patients with any coagulation, bleeding or blood disorders.
  7. Patients who are sensitive or allergic to aspirin.
  8. Patients with documented history of any gastrointestinal disorders, including bleeding ulcers.
  9. 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.
  10. Patients with asthma, rhinitis, or nasal polyps.
  11. 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.
  12. Patients with Class IV heart failure.
  13. Patients with severe aortic insufficiency, or aortic regurgitation.
  14. Patients with hearing loss or tinnitus.
  15. Patients with tremors which cause them not to be able to remain motionless for approximately 30 seconds.

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): NCT00272311

United States, Maryland
HeartDrug Research, LLC
Towson, Maryland, United States, 21204
Sponsors and Collaborators
Florida Atlantic University
Principal Investigator: Charles H Hennekens, MD, DrPH Florida Atlantic University
Study Director: Wendy R Schneider, MSN, CCRC Florida Atlantic University


Responsible Party: Florida Atlantic University Identifier: NCT00272311     History of Changes
Other Study ID Numbers: H08-35
First Posted: January 5, 2006    Key Record Dates
Results First Posted: June 19, 2012
Last Update Posted: June 25, 2012
Last Verified: June 2012

Keywords provided by Florida Atlantic University:
Primary prevention
Cardiovascular diseases
Metabolic Syndrome X

Additional relevant MeSH terms:
Metabolic Syndrome X
Cardiovascular Diseases
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Arterial Occlusive Diseases
Vascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors