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Acute Candesartan Cilexetil Outcomes Stroke Trial

Not Applicable
Completed
Conditions
Acute stroke
Circulatory System
Stroke, not specified as haemorrhage or infarction
Registration Number
ISRCTN76657275
Lead Sponsor
City Hospitals Sunderland NHS Foundation Trust (UK)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
50
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.

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
The early effects of Candesartan upon blood pressure following stroke when used within an explicit evidence based protocol.
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