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ISRCTN
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ISRCTN76657275
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ClinicalTrials.gov identifier
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Public title
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Acute Candesartan Cilexetil Outcomes Stroke Trial
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Scientific title
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Acronym
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ACCOST
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Serial number at source
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0002
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Study hypothesis
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To determine the clinical effectiveness of the ARB Candesartan Cilexetil in improving outcome following acute stroke when administered within the first 72 hours.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised double blind placebo controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Acute stroke
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Participants - inclusion criteria
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1. Clinical diagnosis of acute ischaemic stroke within 72 hours of symptom onset (proven on CT imaging).
2. Medically stable with no evidence of acute infection and not receiving antibiotic therapy.
3. Neurologically stable with no progression on NIHSS.
4. Able to swallow safely and able to tolerate unthickened oral fluids without risk of aspiration.
5. Mean blood pressure in the unaffected arm >120/70 from three readings taken within one hour at twenty minute intervals using a calibrated Omron M5-1 BP monitor.
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Participants - exclusion criteria
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1. Previous severe disability (Modified Rankin Score greater to or equal to 3).
2. Nursing home resident.
3. Previous history of congestive cardiad failure requiring treatment with an ACE inhibitor or Angiotensin Receptor Blocker (ARB).
4. Renal impairment (defined serum creatinine >200 umol/l).
5. Women of child bearing potential.
6. Minors aged less than 18.
7. History of evidence of dementia without capacity for consent.
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Anticipated start date
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01/12/2004
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Anticipated end date
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01/06/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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50
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Interventions
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Patients will be randomised to receive either Candesartan (intervention group) or placebo. After four weeks of double blind treatment, patients will have their clinic blood pressure treated to target level (<140/85) with either a Candesartan based regimen (active group) or an Angiotensin Concerting Enzyme Inhibitor (ACEI) based regimen 'usual best care' (control group). Patients will be followed to 12 weeks post stroke.
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Primary outcome measure(s)
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To determine the safety of the proposed methodology and how many primary end points (combined or single) may be configured for evaluation in a large randomised controlled trial.
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Secondary outcome measure(s)
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The early effects of Candesartan upon blood pressure following stroke when used within an explicit evidence based protocol.
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Sources of funding
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Takeda UK Ltd. (UK) - Unrestricted educational grant
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Trial website
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Publications
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Contact name
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Prof
Chris
Gray
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Address
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City Hospitals Sunderland NHS Foundation Trust
Kayll Road
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City/town
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Sunderland
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Zip/Postcode
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SR4 7TP
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Country
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United Kingdom
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Tel
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+44 (0)191 5656256 ext 42143
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Fax
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+44 (0)191 5699238
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Email
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chris.gray@chs.northy.nhs.uk
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Sponsor
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City Hospitals Sunderland NHS Foundation Trust (UK)
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Address
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Research & Development
Kayll Road
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City/town
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Sunderland
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Zip/Postcode
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SR6 0LA
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Country
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United Kingdom
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Date applied
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07/09/2005
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Last edited
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07/10/2009
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Date ISRCTN assigned
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14/09/2005
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