Design of the rivaroxaban for heparin-induced thrombocytopenia study

被引：29

作者：

Linkins, Lori-Ann ^{[1
]}

Warkentin, Theodore E. ^{[2
,3
]}

Pai, Menaka ^{[2
,3
,4
]}

Shivakumar, Sudeep ^{[5
]}

Manji, Rizwan A. ^{[6
]}

Wells, Philip S. ^{[7
]}

Crowther, Mark A. ^{[2
,3
]}

机构：

[1] McMaster Univ, Dept Med, Hamilton, ON L8S 4K1, Canada

[2] McMaster Univ, Dept Med, Hamilton, ON L8S 4K1, Canada

[3] McMaster Univ, Dept Pathol & Mol Med, Hamilton, ON L8S 4K1, Canada

[4] McMaster Univ, Hamilton Reg Lab, Program Med, Hamilton, ON L8S 4K1, Canada

[5] Dalhousie Univ, Dept Med, Halifax, NS, Canada

[6] Univ Manitoba, Dept Surg, Cardiac Sci Program, Winnipeg, MB R3T 2N2, Canada

[7] Univ Ottawa, Ottawa Hosp Res Inst, Dept Med, Ottawa, ON, Canada

来源：

JOURNAL OF THROMBOSIS AND THROMBOLYSIS | 2014年 / 38卷 / 04期

关键词：

Heparin-induced thrombocytopenia; Rivaroxaban; Study design; Clinical trial; FACTOR-XA INHIBITOR; VENOUS THROMBOEMBOLISM; ORAL RIVAROXABAN; FONDAPARINUX; PREVENTION; PHARMACOKINETICS; WARFARIN; THERAPY; FAILURE; PLACEBO;

D O I：

10.1007/s11239-014-1064-7

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Rivaroxaban is an ideal potential candidate for treatment of heparin-induced thrombocytopenia (HIT) because it is administered orally by fixed dosing, requires no laboratory monitoring and is effective in the treatment of venous and arterial thromboembolism in other settings. The Rivaroxaban for HIT study is a prospective, multicentre, single-arm, cohort study evaluating the incidence of new symptomatic venous and arterial thromboembolism in patients with suspected or confirmed HIT who are treated with rivaroxaban. Methodological challenges faced in the design of this study include heterogeneity of the patient population, differences in the baseline risk of thrombosis and bleeding dependent on whether HIT is confirmed or just suspected, and heterogeneity in laboratory confirmation of HIT. The rationale for how these challenges were addressed and the final design of the Rivaroxaban for HIT study is reviewed.

引用

页码：485 / 492

页数：8

共 42 条

[1]

[Anonymous], 2007, HEPARIN INDUCED THRO

[2] Oral Rivaroxaban for Symptomatic Venous Thromboembolism. [J].

Bauersachs, Rupert ;

Berkowitz, Scott D. ;

Brenner, Benjamin ;

Buller, Harry R. ;

Decousus, Herve ;

Gallus, Alex S. ;

Lensing, Anthonie W. ;

Misselwitz, Frank ;

Prins, Martin H. ;

Raskob, Gary E. ;

Segers, Annelise ;

Verhamme, Peter ;

Wells, Phil ;

Agnelli, Giancarlo ;

Bounameaux, Henri ;

Cohen, Alexander ;

Davidson, Bruce L. ;

Piovella, Franco ;

Schellong, Sebastian .

NEW ENGLAND JOURNAL OF MEDICINE, 2010, 363 (26) :2499-2510

[3] Challenges to the design and execution of controlled clinical studies of anticoagulants in patients with heparin-induced thrombocytopenia: lessons learned [J].

Boyce, Steven W. .

JOURNAL OF THROMBOSIS AND THROMBOLYSIS, 2012, 33 (01) :124-128

[4] A Randomized, Open-Label Pilot Study Comparing Desirudin and Argatroban in Patients With Suspected Heparin-Induced Thrombocytopenia With or Without Thrombosis: PREVENT-HIT Study [J].

Boyce, Steven W. ;

Bandyk, Dennis F. ;

Bartholomew, John R. ;

Frame, James N. ;

Rice, Lawrence .

AMERICAN JOURNAL OF THERAPEUTICS, 2011, 18 (01) :14-22

[5] Comparison of the Effectiveness and Safety of Low-Molecular Weight Heparin Versus Unfractionated Heparin Anticoagulation After Heart Valve Surgery [J].

Bucci, Claudia ;

Geerts, William H. ;

Sinclair, Andrew ;

Fremes, Stephen E. .

AMERICAN JOURNAL OF CARDIOLOGY, 2011, 107 (04) :591-594

[6] Oral Rivaroxaban for the Treatment of Symptomatic Pulmonary Embolism [J].

Buller, Harry R. ;

Prins, Martin H. ;

Lensing, Anthonie W. A. ;

Decousus, Herve ;

Jacobson, Barry F. ;

Minar, Erich ;

Chlumsky, Jaromir ;

Verhamme, Peter ;

Wells, Phil ;

Agnelli, Giancarlo ;

Cohen, Alexander ;

Berkowitz, Scott D. ;

Bounameaux, Henri ;

Davidson, Bruce L. ;

Misselwitz, Frank ;

Gallus, Alex S. ;

Raskob, Gary E. ;

Schellong, Sebastian ;

Segers, Annelise .

NEW ENGLAND JOURNAL OF MEDICINE, 2012, 366 (14) :1287-1297

[7] Efficacy and safety of fondaparinux for the prevention of venous thromboembolism in older acute medical patients: randomised placebo controlled trial [J].

Cohen, AT ;

Davidson, BL ;

Gallus, AS ;

Lassen, MR ;

Prins, MH ;

Tomkowski, W ;

Turpie, AGG ;

Egberts, JFM ;

Lensing, AWA .

BMJ-BRITISH MEDICAL JOURNAL, 2006, 332 (7537) :325-327

[8] Dalteparin versus Unfractionated Heparin in Critically Ill Patients [J].

Cook, Deborah ;

Meade, Maureen ;

Guyatt, Gordon ;

Walter, Stephen ;

Heels-Ansdell, Diane ;

Warkentin, Theodore E. ;

Zytaruk, Nicole ;

Crowther, Mark ;

Geerts, William ;

Cooper, D. Jamie ;

Vallance, Shirley ;

Qushmaq, Ismael ;

Rocha, Marcelo ;

Berwanger, Otavio ;

Vlahakis, Nicholas E. .

NEW ENGLAND JOURNAL OF MEDICINE, 2011, 364 (14) :1305-1314

[9] Thrombocytopenia in medical-surgical critically ill patients: prevalence, incidence, and risk factors [J].

Crowther, MA ;

Cook, DJ ;

Meade, MO ;

Griffith, LE ;

Guyatt, GH ;

Arnold, DM ;

Rabbat, CG ;

Geerts, WH ;

Warkentin, TE .

JOURNAL OF CRITICAL CARE, 2005, 20 (04) :348-353

[10] Predictive value of the 4Ts scoring system for heparin-induced thrombocytopenia: a systematic review and meta-analysis [J].

Cuker, Adam ;

Gimotty, Phyllis A. ;

Crowther, Mark A. ;

Warkentin, Theodore E. .

BLOOD, 2012, 120 (20) :4160-4167

← 1 2 3 4 5 →