NCT01104337

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2007

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 15, 2010

Completed
Last Updated

April 15, 2010

Status Verified

February 1, 2010

Enrollment Period

1.7 years

First QC Date

April 12, 2010

Last Update Submit

April 13, 2010

Conditions

Deep Venous ThrombosisPulmonary EmbolismAtrial FibrillationStrokeAntiphospholipid Syndrome

Keywords

paracetamolwarfarindrug interactionpathogenic mechanism

Outcome Measures

Primary Outcomes (1)

  • The mean maximum increase in INR from baseline to Day 10 (INR (max-D1))

    10 days

Secondary Outcomes (7)

  • The mean maximum INR (INRmax)

    10 days

  • The time to the first variation of INR observed

    10 days

  • Day 10 - Day 1 differences in factors II, V, VII, AT-III plasma concentrations between groups.

    10 days

  • Day 10 - Day 1 differences in paracetamol plasma concentration between groups.

    10 days

  • Day 10 - Day 1 differences in R(-), S(-)warfarin plasma concentrations between groups.

    10 days

  • +2 more secondary outcomes

Study Arms (3)

Paracetamol 2g/d

EXPERIMENTAL

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

Drug: paracetamol

Paracetamol 3g/d

EXPERIMENTAL

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

Drug: paracetamol

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

paracetamolDRUG

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 2g/d
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Therapeutic Research Unit, Department of Internal Medicine, Hospital Lariboière

Paris, 75010, France

Location

MeSH Terms

Conditions

Venous ThrombosisPulmonary EmbolismAtrial FibrillationStrokeAntiphospholipid Syndrome

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolismArrhythmias, CardiacHeart DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Stephane Mouly, MD, PhD

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

    PRINCIPAL INVESTIGATOR

  • Guy Simoneau, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 12, 2010

First Posted

April 15, 2010

Study Start

March 1, 2007

Primary Completion

November 1, 2008

Study Completion

February 1, 2010

Last Updated

April 15, 2010

Record last verified: 2010-02

Locations

FR(1)