Paracetamol and Endothelial Function in Patients With Stable Coronary Artery Disease
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|ClinicalTrials.gov Identifier: NCT00534651|
Recruitment Status : Completed
First Posted : September 26, 2007
Last Update Posted : March 16, 2010
|Condition or disease||Intervention/treatment||Phase|
|Coronary Arteriosclerosis Endothelial Function||Drug: Paracetamol||Phase 4|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Paracetamol and Endothelial Function in Patients With Stable Coronary Artery Disease|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
- Drug: Paracetamol
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00534651
|Zurich, Switzerland, 8091|
|Principal Investigator:||Frank Ruschitzka, MD||University of Zurich|