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. |
ClinicalTrials.gov Identifier: NCT00534651 |
Recruitment Status
:
Completed
First Posted
: September 26, 2007
Last Update Posted
: March 16, 2010
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronary Arteriosclerosis Endothelial Function | Drug: Paracetamol | Phase 4 |
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 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 |

-
Drug: Paracetamol
- 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 ]
- To investigate the effect of paracetamol on markers of inflammation and oxidative stress as well as platelet function [ Time Frame: two weeks ]

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.
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

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
Switzerland | |
University Hospital | |
Zurich, Switzerland, 8091 |
Principal Investigator: | Frank Ruschitzka, MD | University of Zurich |
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 |