Status:
COMPLETED
Aspirin Dose and Atherosclerosis in Patients With Heart Disease
Lead Sponsor:
Florida Atlantic University
Collaborating Sponsors:
Bayer
Conditions:
Cardiovascular Diseases
Atherosclerosis
Eligibility:
All Genders
40-80 years
Phase:
PHASE4
Brief 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.
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. Low dose aspirin is suffici...
Eligibility Criteria
Inclusion
- Age 40 to 80 years, inclusive.
- Patients with stable coronary disease, with and without diabetes mellitus, defined by:
- angiographic evidence of 70% or greater stenosis, or
- previous percutaneous coronary intervention (PCI), or
- coronary artery bypass graft (CABG), or
- history of a MI, or
- positive exercise test
Exclusion
- Patients taking greater than 81mg aspirin daily.
- 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.
- Patients within 6 months of a coronary intervention, including PCI or CABG.
- Patients with a planned coronary intervention.
- Patients taking anti-platelet drugs such as clopidogrel or non-steroidal anti-inflammatory drugs (NSAIDs) or anticoagulant drugs such as warfarin.
- Patients who are currently cigarette smokers.
- Women patients who are pregnant, planning to become pregnant, nursing a child, or taking hormone replacement therapy.
- Patients with any coagulation, bleeding or blood disorders.
- Patients who are sensitive or allergic to aspirin.
- Patients with documented history of any gastrointestinal disorders, including bleeding ulcers.
- Patients with any evidence of cancer or kidney, liver, lung, blood, or brain disorders.
- Patients with asthma, rhinitis, or nasal polyps.
- 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.
- Patients with Class IV heart failure.
- Patients with severe aortic insufficiency, or aortic regurgitation.
- Patients with hearing loss or tinnitus.
- Patients with tremors which cause them not to be able to remain motionless for approximately 30 seconds.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00272337
Start Date
October 1 2006
End Date
June 1 2009
Last Update
December 28 2018
Active Locations (2)
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1
Florida Cardiovascular Research
Atlantis, Florida, United States, 33462
2
The Broward Heart Group, P.A.
Tamarac, Florida, United States, 33321