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Paracetamol and Endothelial Function in Patients With Stable Coronary Artery Disease

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ClinicalTrials.gov Identifier: NCT00534651
Recruitment Status : Completed
First Posted : September 26, 2007
Last Update Posted : March 16, 2010
Sponsor:
Information provided by:
University of Zurich

Study Description
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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


Study Design
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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

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U.S. FDA Resources

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

Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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 ClinicalTrials.gov identifier (NCT number): NCT00534651


Locations
Switzerland
University Hospital
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Frank Ruschitzka, MD University of Zurich
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof Frank Ruschitzka, Cardiovascular Center, Cardiology University Hospital Zurich
ClinicalTrials.gov Identifier: NCT00534651     History of Changes
Other Study ID Numbers: EK1265
First Posted: September 26, 2007    Key Record Dates
Last Update Posted: March 16, 2010
Last Verified: March 2010

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arteriosclerosis
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
 Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics