Aspirin Dose and Atherosclerosis in Patients With Heart Disease

Last updated: December 4, 2018
Sponsor: Florida Atlantic University
Overall Status: Completed

Phase

4

Condition

Coronary Artery Disease

Hypercholesterolemia

Heart Defect

Treatment

N/A

Clinical Study ID

NCT00272337
H08-36
  • Ages 40-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  1. Age 40 to 80 years, inclusive.

  2. Patients with stable coronary disease, with and without diabetes mellitus, defined by:

  3. angiographic evidence of 70% or greater stenosis, or

  4. previous percutaneous coronary intervention (PCI), or

  5. coronary artery bypass graft (CABG), or

  6. history of a MI, or

  7. positive exercise test

Exclusion

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 planto take them for the first time during the next 3 months: ACE-inhibitors, angiotensinreceptor 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-steroidalanti-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, ortaking 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 bleedingulcers.

  11. Patients with any evidence of cancer or kidney, liver, lung, blood, or braindisorders.

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

  13. Patients with any abnormal laboratory value or physical finding that, in the view ofthe responsible clinician, may interfere with interpretation of the trial results, beindicative 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 forapproximately 30 seconds.

Study Design

Total Participants: 37
Study Start date:
October 01, 2006
Estimated Completion Date:
June 30, 2009

Study 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.

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.

Connect with a study center

  • Florida Cardiovascular Research

    Atlantis, Florida 33462
    United States

    Site Not Available

  • The Broward Heart Group, P.A.

    Tamarac, Florida 33321
    United States

    Site Not Available

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