Paracetamol and Endothelial Function in Patients With Stable Coronary Artery Disease

Coronary Arteriosclerosis Clinical Trial

Official title:

Paracetamol and Endothelial Function in Patients With Stable Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00534651
• Other study ID #: EK1265
• Status: Completed
• Phase: Phase 4
• Start date: November 2006
• Est. completion date: January 2010

Study information

• Verified date: November 2019
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arteriosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Coronary Disease
• Endothelial Function
• Myocardial Ischemia

Intervention

Drug:
• Paracetamol
Paracetamol 3x1000mg daily or Placebo for two weeks in a crossover design with a two-week washout-phase in between.

Locations

Country	Name	City	State
Switzerland	University Hospital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	To investigate the effect of paracetamol on markers of inflammation and oxidative stress as well as platelet function		two weeks