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Paracetamol and Endothelial Function in Patients With Stable Coronary Artery Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00534651
Recruitment Status : Completed
First Posted : September 26, 2007
Last Update Posted : December 3, 2019
Information provided by (Responsible Party):
University of Zurich

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

Condition or disease Intervention/treatment Phase
Coronary Arteriosclerosis Endothelial Function Drug: Paracetamol Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
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
Study Start Date : November 2006
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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 ]
  2. 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 :
  1. To investigate the effect of paracetamol on markers of inflammation and oxidative stress as well as platelet function [ Time Frame: two weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00534651

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Zurich Identifier: NCT00534651    
Other Study ID Numbers: EK1265
First Posted: September 26, 2007    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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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