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Paracetamol and Endothelial Function in Patients With Stable Coronary Artery Disease

Primary Purpose

Coronary Arteriosclerosis, Endothelial Function

Status

Completed

Phase

Phase 4

Locations

Switzerland

Study Type

Interventional

Intervention

Paracetamol

About this trial

This is an interventional prevention trial for Coronary Arteriosclerosis

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital

Outcomes

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.

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.

Secondary Outcome Measures

To investigate the effect of paracetamol on markers of inflammation and oxidative stress as well as platelet function

Full Information

NCT ID

NCT00534651

First Posted

September 24, 2007

Last Updated

November 28, 2019

Sponsor

University of Zurich

1. Study Identification

Unique Protocol Identification Number

NCT00534651

Brief Title

Paracetamol and Endothelial Function in Patients With Stable Coronary Artery Disease

Official Title

Paracetamol and Endothelial Function in Patients With Stable Coronary Artery Disease

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

November 2006 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Zurich

4. Oversight

Data Monitoring Committee

5. Study Description

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Arteriosclerosis, Endothelial Function

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Paracetamol

Intervention Description

Paracetamol 3x1000mg daily or Placebo for two weeks in a crossover design with a two-week washout-phase in between.

Primary Outcome Measure Information:

Title

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

Title

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 Measure Information:

Title

To investigate the effect of paracetamol on markers of inflammation and oxidative stress as well as platelet function

Time Frame

two weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frank Ruschitzka, MD

Organizational Affiliation

University of Zurich

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital

City

Zurich

ZIP/Postal Code

8091

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

20956208

Citation

Sudano I, Flammer AJ, Periat D, Enseleit F, Hermann M, Wolfrum M, Hirt A, Kaiser P, Hurlimann D, Neidhart M, Gay S, Holzmeister J, Nussberger J, Mocharla P, Landmesser U, Haile SR, Corti R, Vanhoutte PM, Luscher TF, Noll G, Ruschitzka F. Acetaminophen increases blood pressure in patients with coronary artery disease. Circulation. 2010 Nov 2;122(18):1789-96. doi: 10.1161/CIRCULATIONAHA.110.956490. Epub 2010 Oct 18.

Results Reference

derived

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Paracetamol and Endothelial Function in Patients With Stable Coronary Artery Disease

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