Cerebrovascular Accident Clinical Trial
Official title:
Acute Candesartan Cilexetil Outcomes Stroke Trial (ACCOST)
The aim of this study is to determine whether it is safe and effective to give the Angiotensin Receptor Blocker (ARB) Candesartan within the first 72 hours following acute stroke.
Lowering blood pressure reduces the risk of first ever and recurrent stroke. There is
extensive evidence that blood pressure should be lowered following acute stroke, even from
so called normal levels. However, it is not clear how soon after acute stroke that blood
pressure should be lowered. Observational studies have demonstrated increased mortality with
both high and low blood pressure. The optimal management of blood pressure in the immediate
post-stroke period remains controversial.
Although uncertainty exists with regard to lowering blood pressure in the acute stages of
stroke, two large randomised controlled trials have demonstrated unequivocally that intense
management of blood pressure started >4 weeks from the onset of stroke significantly reduces
the risk of recurrent stroke. Both of these trials have used an Angiotensin Converting
Enzyme Inhibitor (ACE-I) based regime. It has been proposed that these benefits may be due
to a direct result of the ACE-I rather than blood pressure lowering per se. Similar
vasculoprotective effects have been seen in ARBs, but evidence of their safety and efficacy
in acute stroke is limited to those patients with the highest blood pressures (>200/110).
The trial (ACCESS) was terminated prematurely due to a positive imbalance in favour of
intervention with the ARB Candesartan. If such interventions are to convey potential benefit
they need to be started as soon as possible following the acute event in order that the
ischaemic cascade which leads to neuronal death may be modified. Further research is first
required in order to demonstrate their safety and efficacy when used in this way.
ACCOST is a two phase randomised controlled trial designed to address this important
research question. Phase I is a four week double blind placebo controlled phase where
patients receive either Candesartan 4 mg daily or matched placebo, with no blood pressure
treatment target. A treatment titration step occurs after two weeks where, subject to
titration criteria, subjects will receive either Candesartan 8 mg daily or matched placebo.
After the first four weeks, the subjects are unblinded and enter Phase II of the trial.
Phase II is an eight week open label comparison of Candesartan and 'usual care' with an
ACE-I based treatment regime. Blood pressure is now treated to reach the British
Hypertension Society target blood pressure of <140/85, with or without additional therapy.
Blinded outcome measures will include neurological recovery based on the National Institutes
of Health Stroke Scale, as well as functional recovery. Incidence of first dose hypotension
and changes in renal function will also be collected.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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