Atrial Fibrillation Clinical Trial
Official title:
Pharmacodynamic Drug Interaction Between Warfarin and Amoxicillin-clavulanic Acid
Several case reports indicate that the use of the antibiotic combination amoxicillin and
clavulanic acid (AM-CLAVAC) can interact with warfarin pharmacodynamics. However, fever per
se might also be responsible of these warfarin overdose reports, as well as the use of high
dose paracetamol.
The aim of the present study is to determine if AM-CLAVAC can increase the pharmacodynamics
of warfarin among patients at steady state Double blinded cross over controlled study vs
placebo performed in 12 evaluable patients treated with warfarin with an INR target 2 to 3
and a stable INR and a stable dose.
Double blinded cross over controlled study vs placebo performed in 12 evaluable patients
treated with warfarin with an INR target 2 to 3 and a stable INR and a stable dose
One period : seven consecutive days of amoxicillin(2g twice daily)- clavulanic acid (125 mg
twice daily) association Wash out period of at least 4 weak with the return to a stable INR
and warfarin dose One period : seven consecutive days of placebo twice daily
Main outcome INR delta Day7-Day
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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