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Completed

NCT Number: NCT01178034

Early Identification of Warfarin Maintenance Dosage

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Thrombosis Centre

Padova, 35128, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calculate warfarin dose using demographic/genetic algorithm

Genetic

Age, body weight and genetic to calculate warfarin dosage

Primary outcomes

  1. 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)

Secondary outcomes

  1. Number of changes in warfarin dosage

    Time frame: Day 0-19

  2. Difference between predicted and actual warfarin maintenance dose

    Time frame: Day 19

  3. Thromboembolic and Bleeding complications

    Time frame: Day 0-30

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 9, 2010
Registry last updated
Oct 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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