Acute Candesartan Cilexetil Outcomes Stroke Trial

ISRCTN	ISRCTN76657275
DOI	https://doi.org/10.1186/ISRCTN76657275
ClinicalTrials.gov (NCT)	NCT00108706
Protocol serial number	0002
Sponsor	City Hospitals Sunderland NHS Foundation Trust (UK)
Funder	Takeda UK Ltd. (UK) - Unrestricted educational grant

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof Chris Gray
Scientific

City Hospitals Sunderland NHS Foundation Trust
Kayll Road
Sunderland
SR4 7TP
United Kingdom

Phone	+44 (0)191 5656256 ext 42143
Email	chris.gray@chs.northy.nhs.uk

Primary study design	Interventional
Study design	Randomised double blind placebo controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Acute Candesartan Cilexetil Outcomes Stroke Trial
Study acronym	ACCOST
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	The early effects of Candesartan upon blood pressure following stroke when used within an explicit evidence based protocol.
Completion date	01/06/2006

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	50
Key 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.
Key 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.
Date of first enrolment	01/12/2004
Date of final enrolment	01/06/2006

City Hospitals Sunderland NHS Foundation Trust

Sunderland
SR4 7TP
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

26/09/2019: ClinicalTrials.gov number added.
24/05/2016: No publications found, verifying study status with principal investigator