Paracetamol and Endothelial Function in Patients With Stable Coronary Artery Disease

This study has been completed.
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00534651
First received: September 24, 2007
Last updated: March 15, 2010
Last verified: March 2010

September 24, 2007
March 15, 2010
November 2006
January 2010   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
To investigate the effect of paracetamol on endothelial function as compared to placebo in patients with stable coronary artery disease. [ Time Frame: 2 weeks ]
Complete list of historical versions of study NCT00534651 on ClinicalTrials.gov Archive Site
To investigate the effect of paracetamol on markers of inflammation and oxidative stress as well as platelet function [ Time Frame: two weeks ] [ Designated as safety issue: No ]
To investigate the effect of paracetamol on markers of inflammation and oxidative stress as well as platelet function [ Time Frame: two weeks ]
Not Provided
Not Provided
 
Paracetamol and Endothelial Function in Patients With Stable Coronary Artery Disease
Paracetamol and Endothelial Function in Patients With Stable Coronary Artery Disease

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

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Coronary Arteriosclerosis
  • Endothelial Function
Drug: Paracetamol
Paracetamol 3x1000mg daily or Placebo for two weeks in a crossover design with a two-week washout-phase in between.
Not Provided
Sudano I, Flammer AJ, Périat 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, Lüscher TF, Noll G, Ruschitzka F. Acetaminophen increases blood pressure in patients with coronary artery disease. Circulation. 2010 Nov 2;122(18):1789-96. Epub 2010 Oct 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
January 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
30 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00534651
EK1265
No
Prof Frank Ruschitzka, Cardiovascular Center, Cardiology University Hospital Zurich
University of Zurich
Not Provided
Principal Investigator: Frank Ruschitzka, MD University of Zurich
University of Zurich
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP