Clinical trial NCT00272337: Aspirin Dose and Atherosclerosis in Patients With Heart Disease
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiovascular Diseases
Atherosclerosis
Myocardial Infarction
Keywords: Cardiovascular diseases
Aspirin
Atherosclerosis
Myocardial Infarction
Lead sponsor: Florida Atlantic University
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2006-01-05
Enrollment: 37
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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.

Primary outcomes:
measure: Change in Nitric Oxide Formation From Baseline to 3 Months.
timeFrame: Baseline to 3 Months (90-97 days)
Secondary outcomes:
Other outcomes:
measure: Change in Inflammatory Markers From Baseline to 3 Months.
timeFrame: Baseline to 3 Months (90-97 days)
measure: Change in Platelet Biomarkers From Baseline to 3 Months.
timeFrame: Baseline to 3 Months (90-97 days)
Locations:
city: Atlantis
country: United States
facility: Florida Cardiovascular Research
state: Florida
city: Tamarac
country: United States
facility: The Broward Heart Group, P.A.
state: Florida
Study officials:
affiliation: Florida Atlantic University
name: Charles H Hennekens, MD, DrPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Florida Atlantic University
name: Wendy R Schneider, MSN, CCRC
role: STUDY_DIRECTOR
References:
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citation: Grosser N, Abate A, Oberle S, Vreman HJ, Dennery PA, Becker JC, Pohle T, Seidman DS, Schroder H. Heme oxygenase-1 induction may explain the antioxidant profile of aspirin. Biochem Biophys Res Commun. 2003 Sep 5;308(4):956-60. doi: 10.1016/s0006-291x(03)01504-3.
citation: Hennekens CH, Dyken ML, Fuster V. Aspirin as a therapeutic agent in cardiovascular disease: a statement for healthcare professionals from the American Heart Association. Circulation. 1997 Oct 21;96(8):2751-3. doi: 10.1161/01.cir.96.8.2751. No abstract available.
citation: Hennekens CH, Hollar D, Baigent C. Sex-related differences in response to aspirin in cardiovascular disease: an untested hypothesis. Nat Clin Pract Cardiovasc Med. 2006 Jan;3(1):4-5. doi: 10.1038/ncpcardio0420. No abstract available.
citation: Hetzel S, DeMets D, Schneider R, Borzak S, Schneider W, Serebruany V, Schroder H, Hennekens CH. Aspirin increases nitric oxide formation in chronic stable coronary disease. J Cardiovasc Pharmacol Ther. 2013 May;18(3):217-21. doi: 10.1177/1074248413482753. Epub 2013 Mar 21.