Stroke Clinical Trial
Official title:
Dose-dependent Drug-drug Interaction Between Paracetamol and Warfarin in Adults Receiving Long-term Oral Anticoagulants: A Randomized Controlled Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Screening
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