Scandinavian Candesartan Acute Stroke Trial (SCAST)

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to assess whether the blood pressure lowering agent candesartan (an angiotensin receptor type 1 blocker) is effective when given to patients with acute stroke and elevated blood pressure.

Hypothesis:

AT1 receptor blockade with candesartan in acute stroke will:

1. reduce the risk of death or major disability at 6 months by a 6% absolute risk reduction, relative to placebo.

2. reduce the risk of the combined event of "vascular" death, myocardial infarction, or stroke during the first 6 months by a 25% relative risk reduction, relative to placebo

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ullevaal University Hospital
• Collaborators: AstraZeneca; Southern-Eastern Norway Health Authorities RHF; Takeda
• Treatments: Candesartan; Candesartan cilexetil

Criteria

Inclusion Criteria:

• Clinical stroke syndrome with limb paresis, not likely to represent a transient ischaemic attack or non-stroke pathology (e.g. cerebral tumour)

• Systolic blood pressure ≥ 140 mm Hg

• Trial treatment possible within 30 hrs of symptom onset. If time of onset is not known, use the time when the patient was last known to be well.

• Consent (subsidiary, assent from legal acceptable representative, or waiver of consent)

• Age >18 years

Exclusion Criteria:

• Markedly reduced consciousness (i.e. Scandinavian Stroke Scale consciousness score ≤ 2)

• Patient already receiving AT1 receptor blocker

• Contraindication to treatment with AT1 receptor blocker, e.g.:

• known renal failure (women: creatinine ≥ 150 µmol/L; men: ≥ 180 µmol/L)

• previously diagnosed bilateral renal artery stenosis

• previously diagnosed high-grade aortic stenosis

• previously diagnosed seriously impaired liver function and/or cholestasis

• known intolerance to candesartan or other tablet ingredients

• Clear indication, in the clinician's view, for start of treatment with AT1 receptor blocker during the treatment period (e.g. chronic heart failure grade III-IV, in the presence of intolerance to ACE inhibitors)

• Clear indication, in the clinician's view, for antihypertensive therapy during the acute phase of stroke (i.e. concurrent hypertensive encephalopathy or aortic dissection, or other situations)

• Other serious or life-threatening disease before the stroke:

• Patient severely mentally or physically disabled (e.g. Mini Mental Status score < 20, or modified Rankin Scale score ≥ 4)

• Life expectancy < 12 months

• Patient unavailable for follow-up (e.g. no fixed address)

• Pregnant or breast-feeding woman