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Sponsored by: |
University of Zurich |
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Information provided by: | University of Zurich |
ClinicalTrials.gov Identifier: | NCT00534651 |
The purpose of this study is to determine the effect of orally given paracetamol on the vascular function in patients with coronary artery disease
Condition | Intervention | Phase |
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Coronary Arteriosclerosis Endothelial Function |
Drug: Paracetamol |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Paracetamol and Endothelial Function in Patients With Stable Coronary Artery Disease |
Estimated Enrollment: | 20 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | December 2007 |
Patients with chronic pain diseases (e.g. osteoarthritis) are dependent on effective medication. NSAIDs are very effective in lowering pain in these patients. Recently there has aroused major concern with regard to cardiovascular side effects and safety, especially in selective cyclooxygenase-2 inhibitors (coxibs) but also in "regular" NSAIDs.
At the moment, there is a big confusion, whether these drugs still should be used, especially in patients with known coronary artery disease. Physicians now try to switch to high dose paracetamol, despite the weaker efficacy in pain relieve, because this drug is considered generally as not harmful.
As there is very few information on the cardiovascular effect of this drug, we plan to perform this study and investigate the impact of paracetamol on endothelial function, an important cardiovascular surrogat marker, on inflammatory markers and on oxidative stress in patients with coronary artery disease on top of standart medication, including asprin
Ages Eligible for Study: | 30 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:- myocardial infarction, unstable angina, stroke within 3 months prior to study entry
Study ID Numbers: | EK1265 |
Study First Received: | September 24, 2007 |
Last Updated: | April 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00534651 |
Health Authority: | Switzerland: Ethikkommission; Switzerland: Swissmedic |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases |
Ischemia Arteriosclerosis Acetaminophen Coronary Artery Disease |
Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Physiological Effects of Drugs Cardiovascular Diseases |
Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions |