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

被引：49

作者：

Do, E. J. ^{[1
]}

Lenzini, P. ^{[1
]}

Eby, C. S. ^{[1
,2
]}

Bass, A. R. ^{[3
]}

McMillin, G. A. ^{[4
]}

Stevens, S. M. ^{[5
]}

Woller, S. C. ^{[5
]}

Pendleton, R. C. ^{[6
]}

Anderson, J. L. ^{[5
]}

Proctor, P. ^{[6
]}

Nunley, R. M. ^{[7
]}

Davila-Roman, V. ^{[8
]}

Gage, B. F. ^{[1
]}

机构：

[1] Washington Univ, Dept Internal Med, St Louis, MO 63110 USA

[2] Washington Univ, Dept Pathol, St Louis, MO 63110 USA

[3] Hosp Special Surg, New York, NY 10021 USA

[4] Univ Utah, Dept Pathol, Salt Lake City, UT USA

[5] Intermt Med Ctr, Salt Lake City, UT USA

[6] Univ Utah, Dept Internal Med, Salt Lake City, UT 84112 USA

[7] Washington Univ, Dept Orthoped Surg, St Louis, MO 63110 USA

[8] Washington Univ, Div Cardiovasc, St Louis, MO 63110 USA

来源：

PHARMACOGENOMICS JOURNAL | 2012年 / 12卷 / 05期

关键词：

pharmacogenetics; warfarin; randomized controlled trial; dosing algorithm; VENOUS THROMBOEMBOLISM; ANTICOAGULANT-THERAPY; CLINICAL FACTORS; CYP2C9; GENOTYPE; RISK-FACTORS; LONG-TERM; VKORC1; INTENSITY; PHARMACOGENETICS; HOSPITALIZATION;

D O I：

10.1038/tpj.2011.18

中图分类号：

Q3 [遗传学];

学科分类号：

071007 ; 090102 ;

摘要：

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 x 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, INR >= 4, and death. The Pharmacogenomics Journal (2012) 12, 417-424; doi:10.1038/tpj.2011.18; published online 24 May 2011

引用

页码：417 / 424

页数：8

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