Early Identification of Warfarin Maintenance Dosage
1 other identifier
interventional
180
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 atrial-fibrillation
Started Oct 2009
Typical duration for phase_3 atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 6, 2010
CompletedFirst Posted
Study publicly available on registry
August 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedOctober 23, 2012
October 1, 2012
3 years
August 6, 2010
October 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
International Normalized Ratio (INR)
Number of INR outside the therapeutic range (INR 2.0-3.0)
Day 0, 5, 7, 9, 12, 15, 19.
Secondary Outcomes (3)
Number of changes in warfarin dosage
Day 0-19
Difference between predicted and actual warfarin maintenance dose
Day 19
Thromboembolic and Bleeding complications
Day 0-30
Study Arms (1)
pharmacogenetic warfarin dose
EXPERIMENTALWarfarin maintenance dose on the basis of demographic/pharmacogenetic data
Interventions
Age, body weight and genetic to calculate warfarin dosage
Eligibility Criteria
You may qualify if:
- Age \>18 years
- Indication to warfarin with INR between 2.0 and 3.0
You may not qualify if:
- Pregnancy
- Drug interactions
- Basal INR \> 1.2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Thrombosis Centre
Padua, 35128, Italy
Related Publications (1)
Pengo V, Zambon CF, Fogar P, Padoan A, Nante G, Pelloso M, Moz S, Frigo AC, Groppa F, Bozzato D, Tiso E, Gnatta E, Denas G, Padayattil Jose S, Padrini R, Basso D, Plebani M. A Randomized Trial of Pharmacogenetic Warfarin Dosing in Naive Patients with Non-Valvular Atrial Fibrillation. PLoS One. 2015 Dec 28;10(12):e0145318. doi: 10.1371/journal.pone.0145318. eCollection 2015.
PMID: 26710337DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vittorio Pengo, M.D.
University of Padova
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Cardiology
Study Record Dates
First Submitted
August 6, 2010
First Posted
August 9, 2010
Study Start
October 1, 2009
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
October 23, 2012
Record last verified: 2012-10