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).

Forskningsoutput: TidskriftsbidragArtikel i vetenskaplig tidskrift

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 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.

Detaljer

Författare
  • Jonathan L Halperin
  • The Executive Steering Committee On behalf of the SPORTIF III and V Study Investigators:
  • Gregory W Albers
  • Hans Christoph Diener
  • Margaretha Grind
  • Jonathan L Halperin
  • Jay Horrow
  • Bertil Olsson
  • Palle Petersen
  • Alec Vahanian
  • Lars Frison
  • Mark Nevinson
  • Stephen Partridge
Externa organisationer
  • The Mount Sinai Medical Center
Forskningsområden

Ämnesklassifikation (UKÄ) – OBLIGATORISK

  • Kardiologi
Originalspråkengelska
Sidor (från-till)431-438
TidskriftAmerican Heart Journal
Volym146
Utgåva nummer3
StatusPublished - 2003
PublikationskategoriForskning
Peer review utfördJa
Externt publiceradJa