A Phase 4 interventional study of Paracetamol in Coronary Arteriosclerosis and Endothelial Function, sponsored by University of Zurich. Completed at 1 site in Switzerland. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-12-03.
Sponsored by University of Zurich · Phase 4, Interventional, and Prevention
The purpose of this study is to determine the effect of orally given paracetamol on the vascular function and on 24-hour blood pressure in patients with coronary artery disease
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 surrogate marker, on inflammatory markers and on oxidative stress in patients with coronary artery disease on top of standard medication, including aspirin
5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.
This study's enrollment of 37 is below the median of 123 across 3,481 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →University of Zurich is the lead sponsor of 1,048 studies on the registry; 131 are open to participants now.
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Inclusion Criteria:
Exclusion Criteria:- myocardial infarction, unstable angina, stroke within 3 months prior to study entry
Paracetamol 3x1000mg daily or Placebo for two weeks in a crossover design with a two-week washout-phase in between.
Primary Efficacy endpoint: To investigate the effect of paracetamol on endothelial function as compared to placebo in patients with stable coronary artery disease.
Time frame: 2 weeks
primary safety endpoint: to evaluate the effect of paracetamol on 24-hour systolic and diastolic blood pressure as compared to placebo in patients with stable coronary artery disease.
Time frame: 2 Weeks
To investigate the effect of paracetamol on markers of inflammation and oxidative stress as well as platelet function
Time frame: two weeks
The record gives a start of Nov 2006, a primary completion of Jan 2010 and a completion of Jan 2010. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Acetaminophen