Aspirin Dose and Atherosclerosis in Patients With Metabolic Syndrome
Condition: Cardiovascular Diseases; Metabolic Syndrome X; Atherosclerosis
MeSH terms: Cardiovascular Diseases; Atherosclerosis; Microvascular Angina; Metabolic Syndrome; Syndrome
Intervention: Aspirin
Intervention description: Dosage
Intervention MeSH terms: Aspirin
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 70.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Primary prevention; Cardiovascular diseases; Aspirin; Metabolic Syndrome X; Atherosclerosis

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.
    

Eligibility criteria:

        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.