Effect of two distinct dosing regimen of acetaminophen on the anticoagulant effect of warfarin - INPAWA 2

Conditions: Arterial and venous thromboembolic disease including atrial fibrillation
MedDRA version: 8.1Level: LLTClassification code 10043565Term: Thromboembolic event

Registration Number: EUCTR2006-006416-30-FR

Lead Sponsor: nité de Recherches Thérapeutiques

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 45

Inclusion Criteria

- Adults patients with a stable INR (target 2-3) treated with warfarin for at least one month
- No recent paracetamol intake during the last two weeks
- No recent treatement modification during the last 7 days
- Who signed written information consent
- In whom a 10 day follow up is possible
- With at least 12g/dL hemoglobin serum level

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Who did not participate in a therapeutic trial during the month prior to the
current study
- Simultaneously participating to a therapeutic trial.
- In whom acetaminophen is contreindicated
- Presenting with severe cognitive impairement

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate that acetaminophen significantly increase the anticoagulant effect of warfarin as assessed by tne INR;Secondary Objective: - Time to INR significant increase<br>- Effect of age on these variation<br>- Effect of drug-drug interactionon anticoagulation factors<br>- Role of NAPQI , the acetaminophen toxic metabolite, on the clinical drug-drug interaction observed;Primary end point(s): To show that 2g per day of acetaminophen is increasing INR by at least 0,5 unit

Secondary Outcome Measures