Paracetamol and Endothelial Function in Patients With Stable Coronary Artery Disease

University of Zurich (UZH)

Status and phase

Completed

Phase 4

Conditions

Endothelial Function

Coronary Arteriosclerosis

Treatments

Drug: Paracetamol

Study type

Interventional

Funder types

Other

Identifiers

NCT00534651

EK1265

Details and patient eligibility

About

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

Full 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

Enrollment

37 patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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