Paracetamol and Endothelial Function in Patients With Stable Coronary Artery Disease
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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 |
- 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 ]
- 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) |
-
Drug: Paracetamol
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 |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00534651
| Switzerland | |
| University Hospital | |
| Zurich, Switzerland, 8091 | |
| Principal Investigator: | Frank Ruschitzka, MD | University of Zurich |
More Information
No publications provided by University of Zurich
Additional 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 Coronary Disease Myocardial Ischemia Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Heart Diseases Vascular Diseases Acetaminophen |
Analgesics Analgesics, Non-Narcotic Antipyretics Central Nervous System Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015