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Paracetamol and Endothelial Function in Patients With Stable Coronary Artery Disease

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

Condition Intervention Phase
Coronary Arteriosclerosis Endothelial Function Drug: Paracetamol Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Paracetamol and Endothelial Function in Patients With Stable Coronary Artery Disease

Resource links provided by NLM:

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • 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 ]
  • 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 ]

Secondary Outcome Measures:
  • To investigate the effect of paracetamol on markers of inflammation and oxidative stress as well as platelet function [ Time Frame: two weeks ]

Enrollment: 37
Study Start Date: November 2006
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Paracetamol
    Paracetamol 3x1000mg daily or Placebo for two weeks in a crossover design with a two-week washout-phase in between.
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


Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00534651

University Hospital
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Principal Investigator: Frank Ruschitzka, MD University of Zurich
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Prof Frank Ruschitzka, Cardiovascular Center, Cardiology University Hospital Zurich Identifier: NCT00534651     History of Changes
Other Study ID Numbers: EK1265
Study First Received: September 24, 2007
Last Updated: March 15, 2010

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics processed this record on September 21, 2017