Paracetamol and Endothelial Function in Patients With Stable Coronary Artery Disease - Full Text View

Sponsor:	University of Zurich
Information provided by:	University of Zurich
ClinicalTrials.gov Identifier:	NCT00534651

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 IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Paracetamol and Endothelial Function in Patients With Stable Coronary Artery Disease

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Acetaminophen CT 2584

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 ]

Estimated Enrollment:	24
Study Start Date:	November 2006
Estimated Study Completion Date:	December 2010

Intervention Details:

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
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534651

Contacts

Contact: Rosy Hug

+41 44 255 93 20

rosy.hug@usz.ch

Locations

Switzerland
University Hospital	Recruiting
zurich, Switzerland, 8091

Sponsors and Collaborators

University of Zurich

Investigators

Principal Investigator:

Frank Ruschitzka, MD

University of Zurich

More Information

No publications provided

Responsible Party:	Cardiovascular Center, Cardiology University Hospital Zurich ( Prof Frank Ruschitzka )
Study ID Numbers:	EK1265
Study First Received:	September 24, 2007
Last Updated:	June 2, 2009
ClinicalTrials.gov Identifier:	NCT00534651 History of Changes
Health Authority:	Switzerland: Ethikkommission; Switzerland: Swissmedic

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Heart Diseases
Myocardial Ischemia
Physiological Effects of Drugs
Vascular Diseases
Arteriosclerosis
Pharmacologic Actions
Coronary Disease
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Cardiovascular Diseases
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Coronary Artery Disease
Acetaminophen

ClinicalTrials.gov processed this record on February 08, 2010