Early Identification of Warfarin Maintenance Dosage

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vittorio Pengo, University of Padova
ClinicalTrials.gov Identifier:
NCT01178034
First received: August 6, 2010
Last updated: October 21, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Genetic: Calculate warfarin dose using demographic/genetic algorithm
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by University of Padova:

Primary Outcome Measures:
  • International Normalized Ratio (INR) [ Time Frame: Day 0, 5, 7, 9, 12, 15, 19. ] [ Designated as safety issue: Yes ]
    Number of INR outside the therapeutic range (INR 2.0-3.0)


Secondary Outcome Measures:
  • Number of changes in warfarin dosage [ Time Frame: Day 0-19 ] [ Designated as safety issue: Yes ]
  • Difference between predicted and actual warfarin maintenance dose [ Time Frame: Day 19 ] [ Designated as safety issue: Yes ]
  • Thromboembolic and Bleeding complications [ Time Frame: Day 0-30 ] [ Designated as safety issue: Yes ]

Enrollment: 180
Study Start Date: October 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01178034

Locations
Italy
Thrombosis Centre
Padova, Italy, 35128
Sponsors and Collaborators
University of Padova
Investigators
Principal Investigator: Vittorio Pengo, M.D. University of Padova
  More Information

No publications provided

Responsible Party: Vittorio Pengo, Professor of Cardiology, University of Padova
ClinicalTrials.gov Identifier: NCT01178034     History of Changes
Other Study ID Numbers: 1643P
Study First Received: August 6, 2010
Last Updated: October 21, 2012
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by University of Padova:
Warfarin
Dose
Pharmacogenetic
INR

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014