ISRCTN ISRCTN76657275
DOI https://doi.org/10.1186/ISRCTN76657275
ClinicalTrials.gov number NCT00108706
Secondary identifying numbers 0002
Submission date
07/09/2005
Registration date
14/09/2005
Last edited
26/09/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
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

Contact information

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

Study information

Study designRandomised double blind placebo controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleAcute Candesartan Cilexetil Outcomes Stroke Trial
Study acronymACCOST
Study objectivesTo 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) studiedAcute stroke
InterventionPatients 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 typeOther
Primary outcome measureTo 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 measuresThe early effects of Candesartan upon blood pressure following stroke when used within an explicit evidence based protocol.
Overall study start date01/12/2004
Completion date01/06/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants50
Key inclusion criteria1. 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 criteria1. 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 enrolment01/12/2004
Date of final enrolment01/06/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

City Hospitals Sunderland NHS Foundation Trust (UK)
Hospital/treatment centre

Research & Development
Kayll Road
Sunderland
SR6 0LA
England
United Kingdom

Funders

Funder type

Industry

Takeda UK Ltd. (UK) - Unrestricted educational grant

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

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