Acute stroke (ischemic or haemoragic)
Conditions
Interventions
Trade Name: Atacand
Product Name: Candesartan Cilexetil
Pharmaceutical Form: Tablet
INN or Proposed INN: Candesartan cilexetil
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrati
Sponsors
Ullevål University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Clinical stroke syndrome with limb paresis, not likely to represent a transient ischaemic attack or non-stroke pathology (e.g. cerebral tumour) 2. Systolic blood pressure = 140 mm Hg (see paragraph 7.1 for details) 3. 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. 4. Consent (subsidiary, assent from legal acceptable representative, or waiver of consent, see paragraph 7.2 in protocol for details) 5. Age >18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Markedly reduced consciousness (e.g. Scandinavian Stroke Scale consciousness score = 2) 2. Patient already receiving AT1 receptor blocker 3. 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 4. Clear indication, in the clinician’s view, for start of treatment with AT1 receptor blocker during the treatment period 5. 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) 6. Other serious or life-threatening disease before the stroke: • patient severely mentally or physically disabled (e.g. Mini Mental Status score < 15-20, or modified Rankin Scale score = 4) • life expectancy < 12 months 7. Patient unavailable for follow-up (e.g. no fixed address) 8. Pregnant or breast-feeding woman
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Is AT1 receptor blockade with candesartan in acute stroke effective in: 1. reducing the risk of death or major disability at 6 months? 2. preventing vascular death, myocardial infarction, or stroke during the first 6 months? ;Secondary Objective: Clinical outcomes: • Scandinavian Stroke Scale score at 7 days and 6 months • Modified Rankin scale score at 1, 3, and 6 months • Barthel Index score at 1, 3, and 6 months • EuroQol score at 6 months • Mini-Mental State score at 3 and 6 months Clinical events During the 6 months’ follow-up period: • Death (all-cause death and “vascular” death) • Recurrent stroke (ischaemic, haemorrhagic, or unspecified) • Myocardial infarction • Combination of the above events • Adverse events (symptomatic hypotension, renal failure, etc.) Health-economic measures: Costs related to: • Length of hospital stay • Discharge disposition • Re-hospitalisations during the first 6 months ;Primary end point(s): Hypothesis: AT1 receptor blockade with candesartan in acute stroke will: 1. reduce the risk of death or major disability at 6 months by 6% relative to placebo. 2. reduce the risk of death, myocardial infarction, or stroke by 25% during the first 6 months, relative to placebo. | — |
Countries
Belgium, Denmark, Estonia, Finland, Germany, Lithuania, Sweden
Outcome results
None listed