Advanced

Ximelagatran Compared with Warfarain for prevention of thromboembolism in patients with nonvalvular atiral fibrillaton: Rationale. Objectives and design of a pair of clinical trials and baseline patient characteristics (SPORTIF III and V).

Halperin, Jonathan L; On behalf of the SPORTIF III and V Study Investigators:, The Executive Steering Committee; Albers, Gregory W; Diener, Hans Christoph; Grind, Margaretha; Halperin, Jonathan L; Horrow, Jay; Olsson, Bertil LU ; Petersen, Palle and Vahanian, Alec, et al. (2003) In American Heart Journal 146(3). p.431-438
Abstract
Background



Ximelagatran is a novel, oral direct thrombin inhibitor under investigation as an alternative to warfarin for prevention of thromboembolism in patients with nonvalvular atrial fibrillation (AF). Two long-term studies in patients with AF and at least one additional risk factor for stroke are underway to compare the safety and efficacy of fixed-dose ximelagatran (36 mg bid) without coagulation monitoring with dose-adjusted warfarin (international normalized ratio 2.0–3.0).

Methods



SPORTIF III is a randomized, open-label, parallel-group study with blinded event assessment involving 3407 patients at 259 sites in 23 countries. SPORTIF V is similar, but with double-blind treatment... (More)
Background



Ximelagatran is a novel, oral direct thrombin inhibitor under investigation as an alternative to warfarin for prevention of thromboembolism in patients with nonvalvular atrial fibrillation (AF). Two long-term studies in patients with AF and at least one additional risk factor for stroke are underway to compare the safety and efficacy of fixed-dose ximelagatran (36 mg bid) without coagulation monitoring with dose-adjusted warfarin (international normalized ratio 2.0–3.0).

Methods



SPORTIF III is a randomized, open-label, parallel-group study with blinded event assessment involving 3407 patients at 259 sites in 23 countries. SPORTIF V is similar, but with double-blind treatment allocation involving 3922 patients at 409 North American sites. The primary end point in each study is the incidence of all strokes and systemic embolic events, and the objective is to establish the noninferiority of ximelagatran relative to warfarin. Secondary end point constellations include (1) death, stroke, systemic embolism, and myocardial infarction; (2) ischemic stroke, transient ischemic attack, and systemic embolism; and (3) bleeding and treatment discontinuation. Blinded central committees adjudicate all end points and monitor patient safety. The studies commenced July 2000; enrollment ended in December 2001. Each study will accrue ≥4000 patient-years and ≥80 primary end points with a minimum per-patient exposure of 12 months. Combined analysis of both studies is also planned.

Results



The demographics of the 2 patient populations are similar and should allow the studies to meet the objective.

Conclusions



The program, the largest conducted in this indication, will determine the safety and antithrombotic efficacy of ximelagatran as an alternative to warfarin for prevention of thromboembolism in patients with AF. (Less)
Please use this url to cite or link to this publication:
author
, et al. (More)
(Less)
publishing date
type
Contribution to journal
publication status
published
subject
in
American Heart Journal
volume
146
issue
3
pages
431 - 438
publisher
Mosby
external identifiers
  • scopus:0041694480
ISSN
1097-6744
DOI
language
English
LU publication?
no
id
9e1d7247-799c-44fc-93f2-7b584a6fa95e (old id 1128274)
date added to LUP
2008-08-26 14:26:42
date last changed
2018-05-29 12:15:46
@article{9e1d7247-799c-44fc-93f2-7b584a6fa95e,
  abstract     = {Background<br/><br>
<br/><br>
Ximelagatran is a novel, oral direct thrombin inhibitor under investigation as an alternative to warfarin for prevention of thromboembolism in patients with nonvalvular atrial fibrillation (AF). Two long-term studies in patients with AF and at least one additional risk factor for stroke are underway to compare the safety and efficacy of fixed-dose ximelagatran (36 mg bid) without coagulation monitoring with dose-adjusted warfarin (international normalized ratio 2.0–3.0).<br/><br>
Methods<br/><br>
<br/><br>
SPORTIF III is a randomized, open-label, parallel-group study with blinded event assessment involving 3407 patients at 259 sites in 23 countries. SPORTIF V is similar, but with double-blind treatment allocation involving 3922 patients at 409 North American sites. The primary end point in each study is the incidence of all strokes and systemic embolic events, and the objective is to establish the noninferiority of ximelagatran relative to warfarin. Secondary end point constellations include (1) death, stroke, systemic embolism, and myocardial infarction; (2) ischemic stroke, transient ischemic attack, and systemic embolism; and (3) bleeding and treatment discontinuation. Blinded central committees adjudicate all end points and monitor patient safety. The studies commenced July 2000; enrollment ended in December 2001. Each study will accrue ≥4000 patient-years and ≥80 primary end points with a minimum per-patient exposure of 12 months. Combined analysis of both studies is also planned.<br/><br>
Results<br/><br>
<br/><br>
The demographics of the 2 patient populations are similar and should allow the studies to meet the objective.<br/><br>
Conclusions<br/><br>
<br/><br>
The program, the largest conducted in this indication, will determine the safety and antithrombotic efficacy of ximelagatran as an alternative to warfarin for prevention of thromboembolism in patients with AF.},
  author       = {Halperin, Jonathan L and On behalf of the SPORTIF III and V Study Investigators:, The Executive Steering Committee and Albers, Gregory W and Diener, Hans Christoph and Grind, Margaretha and Halperin, Jonathan L and Horrow, Jay and Olsson, Bertil and Petersen, Palle and Vahanian, Alec and Frison, Lars and Nevinson, Mark and Partridge, Stephen},
  issn         = {1097-6744},
  language     = {eng},
  number       = {3},
  pages        = {431--438},
  publisher    = {Mosby},
  series       = {American Heart Journal},
  title        = {Ximelagatran Compared with Warfarain for prevention of thromboembolism in patients with nonvalvular atiral fibrillaton: Rationale. Objectives and design of a pair of clinical trials and baseline patient characteristics (SPORTIF III and V).},
  url          = {http://dx.doi.org/},
  volume       = {146},
  year         = {2003},
}