Condition category
Circulatory System
Date applied
07/09/2005
Date assigned
14/09/2005
Last edited
24/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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 measures

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

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

Sponsor information

Organisation

City Hospitals Sunderland NHS Foundation Trust (UK)

Sponsor details

Research & Development
Kayll Road
Sunderland
SR6 0LA
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/05/2016: No publications found, verifying study status with principal investigator