Stroke Prevention using an ORal Thrombin Inhibitor in atrial Fibrillation V (2005)


Prevention of VTE in non-valvular AF

Close this section


To compare the efficacy of ximelagatran with warfarin for the prevention of stroke and systemic embolism

Close this section

Trial design

Randomized, double-blind phase III study, non-inferiority design
Active treatment: ximelagatran 36 mg twice daily (n=1960)
Control treatment: warfarin (INR 2.0–3.0) (n=1962)

Close this section


Primary endpoint: all strokes (ischemic or hemorrhagic) and systemic embolic events
Secondary endpoints: composite of stroke, systemic embolic events, death, myocardial infarction; composite of ischemic stroke, TIA, systemic embolic events; major bleeding; major and minor bleeding; adverse events

Close this section

Trial participants

3922 patients with non-valvular AF and additional stroke risk factors

Close this section


Efficacy outcome: In the intent-to-treat population, primary events occurred in 51 of 1960 patients (1.6%) in the ximelagatran group and in 37 of 1962 patients (1.2%) in the warfarin group (absolute difference 0.45%; p<0.001 for the predefined non-inferiority hypothesis).The primary event or death occurred in 153 patients given ximelagatran (4.8%) and 151 patients given warfarin (4.7%)
Safety outcome: In the on-treatment population, major and minor bleeding occurred in 737 patients (37%) with ximelagatran compared to 903 patients (47%) with warfarin (relative risk reduction 21%). Almost all events were minor bleedings. There was no significant difference in major bleedings. Elevations of serum ALT levels above 3x ULN were observed in 6% of the patients treated with ximelagatran compared to 0.8% of the patients receiving warfarin

Close this section


Efficacy: In high-risk patients with atrial fibrillation, fixed-dose oral ximelagatran was non-inferior to warfarin

  • in the prevention of stroke and SEE
  • in the prevention of stroke, SEE and death

Safety: Compared to warfarin ximelagatran was associated with a

  • lower total bleeding rate
  • lower minor bleeding rate
  • comparable rate of major bleeding
  • higher incidence of liver enzyme elevations requiring further consideration

Close this section


Albers GW, Diener HC, Frison L, Grind M, Nevinson M, Partridge S, Halperin JL, Horrow J, Olsson SB, Petersen P, Vahanian A for the SPORTIV V investigators. Ximelagatran vs warfarin for stroke prevention in patients with nonvalvular atrial fibrillation: a randomized trial. J Am Med Ass 2005;293:690-698

Close this section

Corresponding author

Jonathan L. Halperin, MD, The Zena and Michael A. Wiener Cardiovascular Institute and The Marie-Josée and Henry R. Kravis Center for Cardiovascular Health, Mount Sinai Medical Center, One Gustave L. Levy Place, New York, NY 10024

Close this section

Back To List

Recommend pageBack to top