NCT00534651

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

December 3, 2019

Status Verified

November 1, 2019

Enrollment Period

3.2 years

First QC Date

September 24, 2007

Last Update Submit

November 28, 2019

Conditions

Coronary ArteriosclerosisEndothelial Function

Outcome Measures

Primary Outcomes (2)

  • Primary Efficacy endpoint: To investigate the effect of paracetamol on endothelial function as compared to placebo in patients with stable coronary artery disease.

    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.

    2 Weeks

Secondary Outcomes (1)

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

    two weeks

Interventions

ParacetamolDRUG

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

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Zurich, 8091, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 20956208DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Frank Ruschitzka, MD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2007

First Posted

September 26, 2007

Study Start

November 1, 2006

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

December 3, 2019

Record last verified: 2019-11

Locations

CH(1)