Contact information
Type
Scientific
Primary contact
Prof Chris Gray
ORCID ID
Contact details
City Hospitals Sunderland NHS Foundation Trust
Kayll Road
Sunderland
SR4 7TP
United Kingdom
+44 (0)191 5656256 ext 42143
chris.gray@chs.northy.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00108706
Protocol/serial number
0002
Study information
Scientific title
Acute Candesartan Cilexetil Outcomes Stroke Trial
Acronym
ACCOST
Study hypothesis
To determine the clinical effectiveness of the ARB Candesartan Cilexetil in improving outcome following acute stroke when administered within the first 72 hours.
Ethics approval
Not provided at time of registration
Study design
Randomised double blind placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Acute stroke
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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.
Secondary outcome measures
The early effects of Candesartan upon blood pressure following stroke when used within an explicit evidence based protocol.
Overall trial start date
01/12/2004
Overall trial end date
01/06/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
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.
Recruitment start date
01/12/2004
Recruitment end date
01/06/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
City Hospitals Sunderland NHS Foundation Trust
Sunderland
SR4 7TP
United Kingdom
Funders
Funder type
Industry
Funder name
Takeda UK Ltd. (UK) - Unrestricted educational grant
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list