Sunday, March 01, 2009

CaSTIA, fASTER AND ARCH


CASTIA
Can acute antiplatelet treatment make a
difference in stroke recurrence? Clopidogrel
in Acute Stroke and TIA (CASTIA) will randomize
a projected 2400 patients with
acute, minor ischemic stroke or TIA within
the first 24 hours of symptom onset; all
patients will be treated with aspirin,
75 mg/day, and will also receive either
placebo or clopidogrel at an initial loading
dose of 300 mg/day followed by maintenance
at 75 mg/day.10,19,20 Primary
composite outcome will include stroke, new
infarction documented by MRI, MI, and
vascular death at 90 days of follow-up.19,20
FASTER
The preventive benefits of acute care are
also the subject of FASTER (Fast Assessment
of Stroke and Transient ischemic attack
to prevent Early Recurrence).21,22 This randomized,
double-blind trial is expected to
enroll 500 stroke/TIA patients at 19 centers
in a pilot phase, eventually enrolling
7500 patients if the pilot proves feasibility.19-23
FASTER will use a 2x2 factorial design: in the
first 24 hours after stroke/TIA, all patients will
be treated with aspirin, and randomized to
placebo or clopidogrel (300 mg/day load,
followed by 75 mg/day) and to placebo or
simvastatin 40 mg/day.19-22 This creates
4 possible treatment arms: aspirin alone,
aspirin + clopidogrel, aspirin + simvastatin,
and aspirin + clopidogrel + simvastatin.23
Eligible patients will not be candidates for
acute thrombolytic therapy.21,22 Patients will
be treated for 1 month, and follow-up will be
90 days.19-22 The primary outcome measure
is recurrent stroke.19,20 Results of FASTER’s
pilot program are anticipated soon,19,20 and
will provide some indication of the utility of
dual antiplatelet therapy, with or without a
statin for short-term stroke prevention.

ARCH
Aortic arch atheroma is a significant risk
factor for ischemic stroke.9 To date, there
has been no evidence regarding the choice
of preventive strategies for recurrent stroke
in this population.9 ARCH (Aortic Arch
Related Cerebral Hazard) is an open,
randomized trial with a projected enrollment
of 1500 patients at 15 centers, enrolling
patients with atherosclerosis of the aortic
arch and a recent (less than 6 months)
cerebral or peripheral embolic event.9,17 The
study will compare oral anticoagulation with
warfarin (target INR, 2-3) vs aspirin 75 to
325 mg/day + clopidogrel 75 mg/day.9 The
primary outcome is a composite of recurrent
stroke, acute MI, peripheral embolism, or
vascular death.9 ARCH will be the first trial to
assess prevention of secondary stroke in
this subpopulation.9

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