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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
History of Changes
  Purpose
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Paracetamol and Endothelial Function in Patients With Stable Coronary Artery Disease

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ 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 ]

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 ] [ Designated as safety issue: No ]
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

  Eligibility
Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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 
Study First Received: September 24, 2007
Last Updated: March 15, 2010
Health Authority: Switzerland: Ethikkommission
Switzerland: Swissmedic

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

ClinicalTrials.gov processed this record on September 30, 2016