Genetics informatics trial (GIFT) of warfarin to prevent deep vein thrombosis (DVT): Rationale and study design

E. J. Do; P. Lenzini; C. S. Eby; A. R. Bass; G. A. McMillin; S. M. Stevens; S. C. Woller; R. C. Pendleton; J. L. Anderson; P. Proctor; R. M. Nunley; V. Davila-Roman; B. F. Gage

doi:10.1038/tpj.2011.18

Genetics informatics trial (GIFT) of warfarin to prevent deep vein thrombosis (DVT): Rationale and study design

E. J. Do, P. Lenzini, C. S. Eby, A. R. Bass, G. A. McMillin, S. M. Stevens, S. C. Woller, R. C. Pendleton, J. L. Anderson, P. Proctor, R. M. Nunley, V. Davila-Roman, B. F. Gage

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63 Scopus citations

Abstract

The risk of venous thromboembolism (VTE) is higher after the total hip or knee replacement surgery than after almost any other surgical procedure; warfarin sodium is commonly prescribed to reduce this peri-operative risk. Warfarin has a narrow therapeutic window with high inter-individual dose variability and can cause hemorrhage. The genetics-informatics trial (GIFT) of warfarin to prevent deep vein thrombosis (DVT) is a 2 × 2 factorial-design, randomized controlled trial designed to compare the safety and effectiveness of warfarin-dosing strategies. GIFT will answer two questions: (1) does pharmacogenetic (PGx) dosing reduce the rate of adverse events in orthopedic patients; and (2) is a lower target international normalized ratio (INR) non-inferior to a higher target INR in orthopedic participants? The composite primary endpoint of the trial is symptomatic and asymptomatic VTE (identified on screening ultrasonography), major hemorrhage, INR4, and death.

Original language	English
Pages (from-to)	417-424
Number of pages	8
Journal	Pharmacogenomics Journal
Volume	12
Issue number	5
DOIs	https://doi.org/10.1038/tpj.2011.18
State	Published - Oct 2012

Keywords

dosing algorithm
pharmacogenetics
randomized controlled trial
warfarin

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Do, E. J., Lenzini, P., Eby, C. S., Bass, A. R., McMillin, G. A., Stevens, S. M., Woller, S. C., Pendleton, R. C., Anderson, J. L., Proctor, P., Nunley, R. M., Davila-Roman, V., & Gage, B. F. (2012). Genetics informatics trial (GIFT) of warfarin to prevent deep vein thrombosis (DVT): Rationale and study design. Pharmacogenomics Journal, 12(5), 417-424. https://doi.org/10.1038/tpj.2011.18

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title = "Genetics informatics trial (GIFT) of warfarin to prevent deep vein thrombosis (DVT): Rationale and study design",

abstract = "The risk of venous thromboembolism (VTE) is higher after the total hip or knee replacement surgery than after almost any other surgical procedure; warfarin sodium is commonly prescribed to reduce this peri-operative risk. Warfarin has a narrow therapeutic window with high inter-individual dose variability and can cause hemorrhage. The genetics-informatics trial (GIFT) of warfarin to prevent deep vein thrombosis (DVT) is a 2 × 2 factorial-design, randomized controlled trial designed to compare the safety and effectiveness of warfarin-dosing strategies. GIFT will answer two questions: (1) does pharmacogenetic (PGx) dosing reduce the rate of adverse events in orthopedic patients; and (2) is a lower target international normalized ratio (INR) non-inferior to a higher target INR in orthopedic participants? The composite primary endpoint of the trial is symptomatic and asymptomatic VTE (identified on screening ultrasonography), major hemorrhage, INR4, and death.",

keywords = "dosing algorithm, pharmacogenetics, randomized controlled trial, warfarin",

author = "Do, {E. J.} and P. Lenzini and Eby, {C. S.} and Bass, {A. R.} and McMillin, {G. A.} and Stevens, {S. M.} and Woller, {S. C.} and Pendleton, {R. C.} and Anderson, {J. L.} and P. Proctor and Nunley, {R. M.} and V. Davila-Roman and Gage, {B. F.}",

note = "Funding Information: This research is funded by the NIH (R01 HL097036). We thank the NIH, FDA and CMS whose constructive criticism improved the trial design. We appreciate the comments of Gerald Moskowitz, PhD, on an earlier draft of the manuscript.",

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doi = "10.1038/tpj.2011.18",

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AU - Bass, A. R.

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AU - Anderson, J. L.

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AU - Nunley, R. M.

AU - Davila-Roman, V.

AU - Gage, B. F.

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Genetics informatics trial (GIFT) of warfarin to prevent deep vein thrombosis (DVT): Rationale and study design

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Keywords

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