Paracetamol and Endothelial Function in Patients With Stable Coronary Artery Disease

Phase 4

Completed

• Conditions: Coronary Arteriosclerosis; Endothelial Function

• Registration Number: NCT00534651
• Lead Sponsor: University of Zurich

Brief Summary

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

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 Timeline

• Study Start: 2006-11
• Study First Submitted: 2007-09-24
• Study First Submitted QC: 2007-09-24
• Study First Posted: 2007-09-26
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-28
• Last Update Posted: 2019-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Primary Efficacy endpoint: To investigate the effect of paracetamol on endothelial function as compared to placebo in patients with stable coronary artery disease.	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.	2 Weeks

Secondary Outcome Measures

Name	Time	Method
To investigate the effect of paracetamol on markers of inflammation and oxidative stress as well as platelet function	two weeks

Trial Locations

Locations (1)

University Hospital; 🇨🇭 Zurich, Switzerland