Acute Candesartan Cilexetil Outcomes Stroke Trial
ISRCTN | ISRCTN76657275 |
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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
Scientific
City Hospitals Sunderland NHS Foundation Trust
Kayll Road
Sunderland
SR4 7TP
United Kingdom
Phone | +44 (0)191 5656256 ext 42143 |
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chris.gray@chs.northy.nhs.uk |
Study information
Study design | Randomised double blind placebo controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 | 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 study start date | 01/12/2004 |
Completion date | 01/06/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
City Hospitals Sunderland NHS Foundation Trust
Sunderland
SR4 7TP
United Kingdom
SR4 7TP
United Kingdom
Sponsor information
City Hospitals Sunderland NHS Foundation Trust (UK)
Hospital/treatment centre
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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