Aspirin and Oxycodone |
ASA and Oxycodone; Endodan; Percodan; Percodan-Demi; Roxiprin |
Clinical Trial: Aspirin Dose and Atherosclerosis in Patients With Heart Disease
This study is not yet open for patient recruitment.
Verified by Florida Atlantic University October 2005
|
Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Cardiovascular Diseases Atherosclerosis Myocardial Infarction | Drug: Aspirin | Phase IV |
MedlinePlus related topics: Heart Attack; Heart Diseases; Vascular Diseases
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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 and Endothelial Function in Secondary Prevention (Patients With Chronic Stable Coronary Disease)
Expected Total Enrollment: 100
Study start: January 2006
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. Aspirin also prevents a first 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
Inclusion Criteria:
- Age 40 to 75 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 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, during the last two weeks.
- 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 hearing loss or tinnitus.
Location and Contact Information
Charles H Hennekens, MD, DrPH chenneke@fau.edu
Florida
Florida Cardiovascular Research, Atlantis, Florida, 33462, United States
Jamie S Kosik, RN,BSN,CCRC 561-548-5538 jamiekosi@aol.com
Steven Borzak, MD, Principal Investigator
The Broward Heart Group, P.A., Tamarac, Florida, 33321, United States
Amy Abreu 954-721-6680 research@browardheartgroup.com
Ricky M Schneider, MD, Principal Investigator
Charles H Hennekens, MD, DrPH, Principal Investigator, Florida Atlantic University
Danielle Hollar, PhD, Study Director, Florida Atlantic University
More Information
Last Updated: January 4, 2006
Record first received: January 3, 2006
ClinicalTrials.gov Identifier: NCT00272337
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10
Resources
- ASA and Oxycodone (Drug Digest)
- Aspirin and Oxycodone (Drug Digest)

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