Table 10Summary of Included Trials

Study and
Design
DispositionPopulationInterventionsFollow-upPrimary
Outcome(s)
ACTIVE-W1922
OL RCT, 2006.
Multicentre, 32
countries
(including Europe /
America).
Randomized: n = 6706
Completed: n = 6026
(90%)
AF patients eligible /
willing to take
anticoagulant therapy,
with ≥ 1 pre-specified
risk factor for stroke.
Clopidogrel plus low-dose ASA
(n = 3335)
Warfarin – INR 2.0 to 3.0 (n = 3371)
1.3 years
(stopped
early)
First occurrence of
stroke, non-CNS SE,
MI, or vascular
death.
AFASAK23
OL/DB RCT, 1989.
Multicentre,
Copenhagen.
Randomized: n = 1007
Completed: n = 785 (80%)
AF patients, with no
recent anticoagulation
or cerebrovascular
event, valve
replacement or
rheumatic heart
disease.
OL Warfarin – INR 2.8 to 4.2 a
(n = 335)
Low-dose ASA (n = 336)
PL (n = 336)
2 yearsThromboembolic
complication: stroke,
TIA or embolic
complication to
viscera /extremities.
AFASAK-224,25
OL RCT, 1998.
Multicentre,
Copenhagen.
Randomized: n = 677
Completed: n = 507 (75%)
AF patients ≥ 60 years
(unless with CV or
pulmonary disease),
without recent TIA or
risk factors for bleeding.
Fixed-dose Warfarin a (n = 167)
Fixed-dose Warfarin plus medium-
dose ASA a (n = 171)
Medium Dose ASA (n = 169)
Warfarin – INR 2.0 to 3.0 (n = 170)
3.5 yearsStroke or SE.
ARISTOTLE2629
DB RCT, 2011.
Multicentre, 39
countries
(including Europe /
America).
Randomized: n = 18201
Completed: n = 13468
(74%)
AF patients with ≥ 1 risk
factor for stroke, without
recent stroke or ASA
> 165 mg.
Apixaban 5 mg b.i.d. (n = 9120;
however, 428 of these patients received
a reduced dose of 2.5 mg b.i.d.)
Warfarin – INR 2.0 to 3.0 (n = 9081)
Concomitant use of ASA (≤ 165 mg daily)
or NSAIDs permitted.
NRStroke or SE;
Major bleeding.
ARISTOTLE-J30
OL/DB RCT, 2011.
Multicentre, Japan.
Randomized: n = 222
Completed: n = 197 (89%)
AF patients with ≥ 1 risk
factor for stroke, without
recent TIA or ASA
> 100 mg.
Apixaban 2.5 mg b.i.d.(n = 74)
Apixaban 5 mg b.i.d.(n = 74)
OL Warfarin – INR 2.0 to 3.0
(n = 74)
Concomitant use of ASA
(≤ 100 mg daily) permitted.
12 weeksComposite of major
bleeding and CRNM
bleeding events.
BAFTA31
OL RCT, 2007.
Multicentre, UK.
Randomized: n = 973
Completed: n = 694 (72%)
AF patients ≥ 75 years,
with clinical uncertainty
around optimal
treatment.
Low-dose ASA (n = 485)
Warfarin – INR 2.0 to 3.0 (n = 488)
2.7 yearsDisabling stroke,
ICH and other
clinically significant
arterial embolism.
CAFA32
DB RCT, 1991.
Multicentre,
Canada.
Randomized: n = 378
Completed: n = 286 (76%)
AF patients without
recent stroke, TIA or MI,
and who did not require
antiplatelet drug
therapy.
Warfarin – INR 2.0 to 3.0 (n = 187)
PL (n = 191)
1.2 years
(stopped
early)
Ischemic stroke, SE,
ICH or fatal
hemorrhage.
JAST33
OL RCT, 2006.
Multicentre, Japan.
Randomized: n = 871
Completed: n = 686 (79%)
AF patients without
recent symptomatic
thromboembolic
disease, ICH or GI
bleeding.
Medium-dose ASA (n = 426)
No treatment (n = 445)
2.1 years
(stopped
early)
CV death,
symptomatic brain
infarction, or TIA.
PETRO34
OL/DB RCT, 2007.
Multicentre, 4
countries (Europe
and USA).
Randomized: n = 502
Completed: n = 464 (92%)
AF patients with ≥ 1 risk
factor for stroke and with
coronary artery disease
(removed halfway to
facilitate recruitment).
No recent MI, stroke,
TIA or major bleed.
Warfarin pre-treatment
required for ≥ 8 weeks.
Dabigatran 50 mg b.i.d. ± Low-dose or
High-dose ASA a (n = 105)
Dabigatran 300 mg b.i.d. ± Low-dose
or High-dose ASA a (n = 161)
Dabigatran 150 mg b.i.d. ± Low-dose
or High-dose ASA b (n = 166)
OL Warfarin – INR 2.0 to 3.0 (n = 70)
12 weeksThromboembolic
events and bleeding
events.
RE-LY3542
OL/DB RCT, 2009.
Multicentre, 44
countries
(including
Europe/America).
Randomized: n = 18113
Completed: n = 14580 (80%)
AF patients with ≥ 1 risk
factor for stroke, without
recent stroke or
increased risk of
bleeding.
Dabigatran 110 mg b.i.d.(n = 6015)
Dabigatran 150 mg b.i.d.(n = 6076)
OL Warfarin – INR 2.0 to 3.0 (n = 6022)
Concomitant use of ASA (< 100 mg daily)
or other antiplatelet agents permitted.
2 yearsStroke or SE and
major hemorrhage.
ROCKET-AF4345
DB RCT, 2011.
Multicentre, 45
countries
(including
Europe/America).
Randomized: n = 14264
Completed: n = 10957
(77%)
AF patients at moderate
to high risk of stroke
(CHADS2 score ≥ 2).
Rivaroxaban 20 mg q.d. (n = 7131;
however, 1,474 of these patients
received a reduced dose of 15 mg q.d.)
Warfarin – INR 2.0 to 3.0 (n = 7133)
Concomitant use of ASA (< 100 mg daily)
permitted. Chronic NSAIDs not allowed.
1.9 yearsComposite of stroke
and SE;
Composite of major
and NMCR bleeding.
WASPO46
OL RCT, 2007.
Multicentre, UK.
Randomized: n = 75
Completed: n = 64 (85%)
Ambulant AF patients >
80 and < 90 years with
Folstein score > 25,
without previous fall,
ICH or GI bleeding.
Patients with prior stroke
or TIA were excluded.
Warfarin – INR 2.0 to 3.0 (n = 36)
Medium-dose ASA (n = 39)
1 yearCombined
endpoints: death;
stroke, TIA or SE;
serious bleeding;
withdrawal.

AF = atrial fibrillation; ASA = acetylsalicylic acid; b.i.d. = twice daily CNS = central nervous system; CRNM = clinically relevant non-major bleeding; CV = cardiovascular; DB = double-blind; GI = gastrointestinal; ICH = intracerebral hemorrhage; MI = myocardial infarction; NR = not reported; NSAIDs = non-steroidal anti-inflammatory drugs; OL = open label; PL = placebo; q.d. = once daily; RCT = randomized controlled trial; SE = systemic embolism; TIA = transient ischemic attack; UK = United-Kingdom; VKA = vitamin K antagonist.

a

No data was extracted from these treatment arms since they did not meet the inclusion criteria specified in the protocol. These trials were nevertheless included in the systematic review because they had at least one relevant comparison between two interventions of interest.

b

Data was extracted only for dabigatran without ASA (n = 100).

From: 4, RESULTS

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Antithrombotic Agents for the Prevention of Stroke and Systemic Embolism in Patients With Atrial Fibrillation [Internet].
CADTH Therapeutic Review, No. 1.1B.
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