Early Identification of Warfarin Maintenance Dosage

October 21, 2012 updated by: Vittorio Pengo, University of Padova

Early Identification of Warfarin Maintenance Dose in Patients With Atrial Fibrillation: a Randomized Trial Evaluating a New Genotype-based Versus Usual Care Initiation of Treatment

Initiation of warfarin therapy is problematic. The investigators goal was to evaluate if a new demographic/pharmacogenetic algorithm is better than a usual algorithm based on INR value at day five after four days of 5 mg/day warfarin. To this end patients with atrial fibrillation starting warfarin are randomized in two arms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of this randomized study is to evaluate the accuracy of a new demographic/pharmacogenetic as compared to usual warfarin dosing algorithm in predicting warfarin maintenance dose. In patients with atrial fibrillation starting anticoagulation, the loading dose of warfarin in the tested group is calculated on the basis of VKORC1 genotype and patient's body weight.The second day warfarin maintenance dose is calculated on the basis of surface area and CYP2C9, CYP4F2 e VKORC1 genotype. In the usual care group the maintenance dose at day 5 is calculated on the basis of a published algorithm (Pengo V, Am J Cardiol 2001). INR is checked on day 0, 5, 7, 9, 12, 15 and 19. Primary end-point of the trial is the number of INR outside the therapeutic range of 2.0 to 3.0. Secondary end-points are the number of changes in dose prescription, the difference between predicted and actual warfarin maintenance dose and thrombotic and bleeding events.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Padova, Italy, 35128
        • Thrombosis Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age >18 years
  • Indication to warfarin with INR between 2.0 and 3.0

Exclusion Criteria:

  • Pregnancy
  • Drug interactions
  • Basal INR > 1.2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pharmacogenetic warfarin dose
Warfarin maintenance dose on the basis of demographic/pharmacogenetic data
Genetic: Calculate warfarin dose using demographic/genetic algorithm
Age, body weight and genetic to calculate warfarin dosage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Normalized Ratio (INR)
Time Frame: Day 0, 5, 7, 9, 12, 15, 19.
Number of INR outside the therapeutic range (INR 2.0-3.0)
Day 0, 5, 7, 9, 12, 15, 19.

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of changes in warfarin dosage
Time Frame: Day 0-19
Day 0-19
Difference between predicted and actual warfarin maintenance dose
Time Frame: Day 19
Day 19
Thromboembolic and Bleeding complications
Time Frame: Day 0-30
Day 0-30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Padova

Investigators

  • Principal Investigator: Vittorio Pengo, M.D., University of Padova

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

August 6, 2010

First Submitted That Met QC Criteria

August 6, 2010

First Posted (Estimate)

August 9, 2010

Study Record Updates

Last Update Posted (Estimate)

October 23, 2012

Last Update Submitted That Met QC Criteria

October 21, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1643P

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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