Aspirin Dose and Atherosclerosis in Patients With Heart Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Double-Blind Trial to Test Higher- Versus Lower-Doses of Aspirin on Inflammatory Markers and Platelet Biomarkers and Nitric Oxide Formation & Endothelial Function in Secondary Prevention (Pts w/Chronic Stable Coronary Disease)

Conditions
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Cardiovascular Diseases, Atherosclerosis, Myocardial Infarction

Intervention / Treatment
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* Drug: Aspirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>81 mg Aspirin | Drug: Aspirin<br>* Dosage<br>|
| Active Comparator: 2<br>162 mg Aspirin | Drug: Aspirin<br>* Dosage<br>|
| Active Comparator: 3<br>325 mg Aspirin | Drug: Aspirin<br>* Dosage<br>|
| Active Comparator: 4<br>650 mg Aspirin | Drug: Aspirin<br>* Dosage<br>|
| Active Comparator: 5<br>1300 mg Aspirin | Drug: Aspirin<br>* Dosage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Nitric Oxide Formation From Baseline to 3 Months. | Heme oxygenase a downstream target of nitric oxide formation | Baseline to 3 Months (90-97 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular diseases, Aspirin, Atherosclerosis, Myocardial Infarction