Paracetamol and Endothelial Function in Patients With Stable Coronary Artery Disease

NCT ID: NCT00534651

Last Updated: 2019-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2010-01-31

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

Conditions

Coronary Arteriosclerosis; Endothelial Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Interventions

Paracetamol

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

Intervention Type: DRUG

Eligibility 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

• 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frank Ruschitzka, MD

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

University Hospital

Zurich, , Switzerland

Countries

Switzerland

References

Sudano I, Flammer AJ, Periat D, Enseleit F, Hermann M, Wolfrum M, Hirt A, Kaiser P, Hurlimann D, Neidhart M, Gay S, Holzmeister J, Nussberger J, Mocharla P, Landmesser U, Haile SR, Corti R, Vanhoutte PM, Luscher TF, Noll G, Ruschitzka F. Acetaminophen increases blood pressure in patients with coronary artery disease. Circulation. 2010 Nov 2;122(18):1789-96. doi: 10.1161/CIRCULATIONAHA.110.956490. Epub 2010 Oct 18.

Reference Type: DERIVED

PMID: 20956208 (View on PubMed)

Other Identifiers

EK1265

Identifier Type: -

Identifier Source: org_study_id