Aspirin Dose and Atherosclerosis in Patients With Heart Disease
Condition: Cardiovascular Diseases; Atherosclerosis; Myocardial Infarction
MeSH terms: Cardiovascular Diseases; Myocardial Infarction; Atherosclerosis; Infarction
Intervention: Aspirin
Intervention description: Dosage
Intervention MeSH terms: Aspirin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 37.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cardiovascular diseases; Aspirin; Atherosclerosis; Myocardial Infarction

Summary:

      The purpose of the study is to test higher versus lower doses of aspirin on markers of
      atherosclerosis in patients who have had a heart attack.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 40 to 80 years, inclusive.

          2. Patients with stable coronary disease, with and without diabetes mellitus, defined by:

               1. angiographic evidence of 70% or greater stenosis, or

               2. previous percutaneous coronary intervention (PCI), or

               3. coronary artery bypass graft (CABG), or

               4. history of a MI, or

               5. positive exercise test

        Exclusion Criteria:

          1. Patients taking greater than 81mg aspirin daily.

          2. 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.

          3. Patients within 6 months of a coronary intervention, including PCI or CABG.

          4. Patients with a planned coronary intervention.

          5. Patients taking anti-platelet drugs such as clopidogrel or non-steroidal
             anti-inflammatory drugs (NSAIDs) or anticoagulant drugs such as warfarin.

          6. Patients who are currently cigarette smokers.

          7. Women patients who are pregnant, planning to become pregnant, nursing a child, or
             taking hormone replacement therapy.

          8. Patients with any coagulation, bleeding or blood disorders.

          9. Patients who are sensitive or allergic to aspirin.

         10. Patients with documented history of any gastrointestinal disorders, including bleeding
             ulcers.

         11. Patients with any evidence of cancer or kidney, liver, lung, blood, or brain
             disorders.

         12. Patients with asthma, rhinitis, or nasal polyps.

         13. Patients with any abnormal laboratory value or physical finding that, in the view of
             the responsible clinician, may interfere with interpretation of the trial results, be
             indicative of an underlying disease state, or compromise the safety.

         14. Patients with Class IV heart failure.

         15. Patients with severe aortic insufficiency, or aortic regurgitation.

         16. Patients with hearing loss or tinnitus.

         17. Patients with tremors which cause them not to be able to remain motionless for
             approximately 30 seconds.