Main characteristics of the included studies
Trial |
Treatments |
Patients |
Methods |
SPORTIF II (ximelagatran vs warfarin standard dose), 2002
|
ximelegatran 20,40,60 mg twice daily
versus
warfarin standard dose(target INR 2-3)
|
Medium to high risk patients with chronic non valvular atrial fibrillation.
|
follow-up 16 weeks
n=187/67
Parallel groups
Open
Europe ,USA
|
SPORTIF III, 2003
|
ximelagatran 36 mg twice daily
versus
warfarin standard dose (target INR 2-3)
|
One or more stroke risk factor in addition to AF.High risk patients with non valvular atrial fibrillation.
|
follow-up 17.4 months
n=1704/1703
Parallel groups
Open
europe,asia,australasia
|
SPORTIF V, 2005
|
ximelegatran 36 mg twice daily
versus
warfarin standard dose(target INR 2-3)
|
One or more stroke risk factor in addition to atrial fibrillation.High risk patients with non valvular atrial fibrillation.
|
follow-up 20 months
n=1960/1962
Parallel groups
Double blind
north america
|
PETRO (150mg), 2007
|
dabigatran
150 mg twice daily (alone or combined with 81- or 325-mg aspirin)
versus
warfarin administered to achieve an international normalized ratio of 2 to 3 for
|
patients
with AF at high risk for thromboembolic events
|
follow-up 12 weeks
n=166/70
Factorial plan
double blind
Denmark, The netehrlands, Sweden, US
|
RE-LY (150mg), 2009
NCT00262600
|
dabigatran 150 mg twice a day
versus
warfarin adjusted-dose to a 2.0 to 3.0 INR
|
Patients With Non-Valvular Atrial Fibrillation
|
follow-up 2 y (median)
n=6076/6022
Parallel groups
open (blind assessment)
44 countries
|
RE-LY (110mg), 2009
NCT00262600
|
dabigatran 110 mg twice a day
versus
warfarin adjusted dose to a 2-3 INR
|
Patients With Non-Valvular Atrial Fibrillation
|
follow-up 2 y (median)
n=6015/6022
Parallel groups
open (blind assessment)
44 countries
|
References
SPORTIF II (ximelagatran vs warfarin standard dose), 2002 :
Petersen P, Grind M, Adler JXimelagatran versus warfarin for stroke prevention in patients with nonvalvular atrial fibrillation. SPORTIF II: a dose-guiding, tolerability, and safety study.
J Am Coll Cardiol 2003 May 7;41:1445-51
[PMID 12742279]
SPORTIF III, 2003 :
Olsson SBStroke prevention with the oral direct thrombin inhibitor ximelagatran compared with warfarin in patients with non-valvular atrial fibrillation (SPORTIF III): randomised controlled trial.
Lancet 2003 Nov 22;362:1691-8
[PMID 14643116]
SPORTIF V, 2005 :
Halperin JLXimelagatran compared with warfarin for prevention of thromboembolism in patients with nonvalvular atrial fibrillation: Rationale, objectives, and design of a pair of clinical studies and baseline patient characteristics (SPORTIF III and V).
Am Heart J 2003 Sep;146:431-8
[PMID 12947359]
SPORTIF V, 2005 :
Albers GW, Diener HC, Frison L, Grind M, Nevinson M, Partridge S, Halperin JL, Horrow J, Olsson SB, Petersen P, Vahanian AXimelagatran vs warfarin for stroke prevention in patients with nonvalvular atrial fibrillation: a randomized trial.
JAMA 2005 Feb 9;293:690-8
[PMID 15701910]
PETRO (150mg), 2007 :
Ezekowitz MD, Reilly PA, Nehmiz G, Simmers TA, Nagarakanti R, Parcham-Azad K, Pedersen KE, Lionetti DA, Stangier J, Wallentin LDabigatran with or without concomitant aspirin compared with warfarin alone in patients with nonvalvular atrial fibrillation (PETRO Study).
Am J Cardiol 2007;100:1419-26
[PMID 17950801]
RE-LY (150mg), 2009 :
Ezekowitz MD, Connolly S, Parekh A, Reilly PA, Varrone J, Wang S, Oldgren J, Themeles E, Wallentin L, Yusuf SRationale and design of RE-LY: randomized evaluation of long-term anticoagulant therapy, warfarin, compared with dabigatran.
Am Heart J 2009;157:805-10, 810.e1-2
[PMID 19376304]
RE-LY (150mg), 2009 :
Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener HC, Joyner CD, Wallentin LDabigatran versus warfarin in patients with atrial fibrillation.
N Engl J Med 2009 Sep 17;361:1139-51
[PMID 19717844] 10.1056/NEJMoa0905561
RE-LY (110mg), 2009 :
Ezekowitz MD, Connolly S, Parekh A, Reilly PA, Varrone J, Wang S, Oldgren J, Themeles E, Wallentin L, Yusuf S
Am Heart J 2009;157:805-10, 810.e1-2
[PMID 19376304]
RE-LY (110mg), 2009 :
Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener HC, Joyner CD, Wallentin LDabigatran versus Warfarin in Patients with Atrial Fibrillation.
N Engl J Med 2009 Aug 30;:
[PMID 19717844] 10.1056.NEJM0a0905561