WSO - April 2023 - 395

Li et al.
395
International Journal of Stroke, 18(4)
Table 2. Characteristics of included randomized clinical trials.
WASH
Publication year
Study design
2004
Multicenter, openlabel,
randomized,
controlled trial
(PROBE)
Major eligibility
criteria
Clinical diagnosis
of HF requiring
diuretic
therapy and no
contraindications
to aspirin and
warfarin
HELAS
2006
International,
multicenter,
randomized,
double-blind,
placebo-controlled
trial
Symptomatic HF
with New York
Heart Association
(NYHA) class
II-IV and EF < 35%
ischemic heart
disease or dilated
cardiomyopathy, no
history of AF
Treatment arms Warfarin (target
INR 2.5) versus
aspirin (300 mg/
day) versus no
antithrombotic
treatment
Warfarin (target
INR 2-3) versus
ASA (325 mg
once daily or
according to sham
adjustment) versus
placebo
Follow-up
duration
(median or
mean), months
Outcomes of
interest
Stroke or systemic
embolism,
major bleeding,
myocardial
infarction, and allcause
mortality
Stroke or systemic
embolism,
major bleeding,
myocardial
infarction, all-cause
mortality, and HF
hospitalization
Stroke or systemic
embolism,
major bleeding,
myocardial
infarction, all-cause
mortality, and HF
hospitalization
Stroke or systemic
embolism, major
bleeding, myocardial
infarction, all-cause
mortality, and HF
hospitalization
Stroke or systemic
embolism,
major bleeding,
myocardial
infarction,
all-cause
mortality, and HF
hospitalization
Major bleeding,
all-cause
mortality, and HF
hospitalization
Stroke or systemic
embolism and major
bleeding,
27
19.3
Symptomatic
HF for at least
3 months with SR
and LV ejection
fraction of ⩽ 35%
Patients in SR who
have a reduced LV
ejection fraction
At least 3-month
history of
chronic HF, a
LV EF ⩽ 40%,
coronary artery
disease, and
treated for
an episode of
worsening HF, no
history of AF
Open-label
warfarin (target
INR 2.5-3.0)
and double-blind
treatment with
either aspirin
(162 mg/day) or
clopidogrel (75 mg/
day)
21
Warfarin (target
INR 2.0- 3.5) versus
aspirin (325 mg/day)
Rivaroxaban
(2.5 mg twice
daily) versus
placebo
WATCH
2009
WARCEF
2012
Multinational,
prospective,
randomized trial
Multicenter, doubleblind
randomized
trial
COMMANDERHF
2018
Multicenter,
randomized,
double-blind
trial
COMPASS
2019
Multicenter,
double-blind,
randomized,
placebocontrolled
trial
Stable patients
with HF and
chronic CAD
or PAD without
need for OAC
Patients with
ischemic stroke, not
associated with more
than 50% luminal
stenosis of the artery
supplying the area of
ischemia, identified
high-risk sources of
cardiac embolism,
including AF
Rivaroxaban
2.5 mg twice
daily plus aspirin
100 mg once daily
or rivaroxaban
5 mg twice daily
to aspirin 100 mg
once daily
42
21.1
23
Rivaroxaban (15 mg
once daily) versus
aspirin (100 mg once
daily)
NAVIGATE ESUS
2021
International,
multicenter, doubleblinded,
randomized
trial
10.4

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