- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00534651
Paracetamol and Endothelial Function in Patients With Stable Coronary Artery Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Zurich, Switzerland, 8091
- University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age: 30 - 80 years
- History of coronary artery disease (documented by coronary angiogram, nuclear imaging, positive stress test)
- Stable cardiovascular medication for at least 1 month
- Written obtained informed consent
Exclusion Criteria:- myocardial infarction, unstable angina, stroke within 3 months prior to study entry
- coronary intervention/revascularisation procedure within 3 months prior to study entry
- Left ventricular ejection fraction <50%
- Other analgesics (Platelet inhibition therapy with Aspirin 100mg/d will be continued)
- Long acting nitrates
- Smoking
- Chronic heart failure (> NYHA II)
- Ventricular tachyarrhythmias
- Renal failure (serum creatinine >200umol)
- Liver disease (ALT or AST >100 IU), especially acute hepatitis
- Hyperbilirubinemia
- Alcohol abuse
- Oral Anticoagulation
- Concomitant therapy with Phenobarbital, Phenytoin, Carbamazepin, Isonicotinic Acid, Chloramphenicol Chlorzoxazone, Zidovudine, Salicylamide
- Insulin-dependent diabetes mellitus
- Drug abuse
- Anemia (Hb<10 g/dl)
- Known allergies on Paracetamol
- Pregnancy
- Malignancy (unless healed or remission > 5 years)
- Symptomatic hypotension, hypertension >160/100 mmHg
- Disease with systemic inflammation (e.g. rheumatoid arthritis, M. Crohn)
- Participation in another study within the last month
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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2 weeks
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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
|
2 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To investigate the effect of paracetamol on markers of inflammation and oxidative stress as well as platelet function
Time Frame: two weeks
|
two weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Frank Ruschitzka, MD, University of Zurich
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arterial Occlusive Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Arteriosclerosis
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antipyretics
- Acetaminophen
Other Study ID Numbers
- EK1265
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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