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Search / Trial NCT01104337

Drug Interaction Between Paracetamol and Warfarin

Launched by HOPITAL LARIBOISIÈRE · Apr 13, 2010

Trial Information

Current as of April 25, 2025

Completed

Keywords

Paracetamol Warfarin Drug Interaction Pathogenic Mechanism

ClinConnect Summary

Paracetamol is recommended as a first-line analgesic and antipyretic therapy in patients receiving short- and long-term oral anticoagulation, especially elderly patient.However,Increased INR was previously observed in patients treated with warfarin and paracetamol given at the maximum recommended dose (4g/day).

To date, the mechanism of this interaction has not been determined.A recent in vitro study suggested that the toxic metabolite N-acetyl-para-benzoquinoneimine (NAPQI) appeared to interfere with vitamin K-dependent γ-carboxylase (VKD-carb) and vitamin K epoxide reductase (VKOR) activ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients treated with warfarin (target INR 2 to 3) stable anticoagulation at 2 to 9 mg for more than 30 days
  • Aged 18 years or older
  • Laboratory values (hemoglobin, blood cell counts, albumin, blood ionogram, complementary hemostasis parameters and aspartate, alanine transaminases (AST and ALT))remained within normal limits
  • Exclusion Criteria:
  • Any treatment change within 7 days before enrollment
  • Any paracetamol intake within the last 14 days
  • Drug allergy Concomitant drug ( 5-fluorouracile, acetylsalicylic acid, non steroidal anti-inflammatory drugs, chloramphenicol, diflunisal, miconazole)
  • St John's wort treatment
  • Pregnancy

About Hopital Lariboisière

Hôpital Lariboisière, a key institution within the Assistance Publique - Hôpitaux de Paris (AP-HP), is a renowned medical facility dedicated to providing high-quality patient care and advancing medical research. With a focus on innovative clinical trials, Hôpital Lariboisière aims to enhance treatment methodologies and improve patient outcomes across various medical specialties. The hospital's multidisciplinary approach fosters collaboration among healthcare professionals, ensuring rigorous adherence to ethical standards and regulatory requirements in clinical research. By prioritizing patient safety and scientific integrity, Hôpital Lariboisière is committed to contributing to the advancement of medical knowledge and the development of effective therapies.

Locations

Paris, , France

Patients applied

0 patients applied

Trial Officials

Stephane Mouly, MD, PhD

Principal Investigator

Therapeutic Research Unit, Department of Internal Medicine, Hospital Lariboisière, Paris, France

Guy Simoneau, MD

Principal Investigator

Therapeutic Research Unit, Department of Internal Medicine, Hospital Lariboisière, Paris, France

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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