Drug Interaction Between Paracetamol and Warfarin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2010-02-28

Brief Summary

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The objective of this study is to investigate whether paracetamol, given at therapeutic doses (2g/day and 3 g/day), may potentiate the anticoagulant effect of warfarin.

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Detailed Description

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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) activites12. The question remaining to be dealt with is whether this in vitro observation can explain the in vivo paracetamol-warfarin interaction. We aim to evaluate the effect of paracetamol at the most widely used doses 2 and 3g/day on INR in stable patients treated with warfarin in a double blind randomized placebo-controlled trial and to identify the mechanism involved in this interaction in vivo.

Conditions

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Deep Venous Thrombosis Pulmonary Embolism Atrial Fibrillation Stroke Antiphospholipid Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Paracetamol 2g/d

18 patients on stable warfarin therapy received a 10-day regimen of paracetamol 2g/d

Group Type EXPERIMENTAL

paracetamol

Intervention Type DRUG

Treatment consisted of two paracetamol 500mg (Doliprane® 500mg, Sanofi-aventis, Paris, France) tablets twice a day along with two matching placebo tablets once daily

Paracetamol 3g/d

18 patients on stable warfarin therapy received a 10-day regimen of paracetamol 3g/d

Group Type EXPERIMENTAL

paracetamol

Intervention Type DRUG

Treatment consisted of two paracetamol 500mg (Doliprane® 500mg, Sanofi-aventis, Paris, France) tablets three times a day

Placebo

9 patients on stable warfarin therapy received a 10-day regimen of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Treatment consisted of two matching placebo tablets three times a day.

Interventions

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paracetamol

Treatment consisted of two paracetamol 500mg (Doliprane® 500mg, Sanofi-aventis, Paris, France) tablets twice a day along with two matching placebo tablets once daily

Intervention Type DRUG

paracetamol

Treatment consisted of two paracetamol 500mg (Doliprane® 500mg, Sanofi-aventis, Paris, France) tablets three times a day

Intervention Type DRUG

Placebo

Treatment consisted of two matching placebo tablets three times a day.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No