Scandinavian Candesartan Acute Stroke Trial (SCAST)

Stroke Clinical Trial

Official title:

Scandinavian Candesartan Acute Stroke Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00120003
• Other study ID #: 050321
• Status: Completed
• Phase: Phase 3
• First received: July 6, 2005
• Last updated: June 30, 2011
• Start date: June 2005
• Est. completion date: September 2010

Study information

• Verified date: September 2006
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencySweden: Medical Products AgencyDenmark: Danish Medicines AgencyBelgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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

Description:

It has long been a controversy whether elevated blood pressure should be lowered in the acute phase of stroke. Current clinical practice is generally to accept high blood pressure in the acute phase of stroke, to avoid reduction of cerebral blood perfusion. This practice has a well-founded theoretical basis, but is not supported by evidence from clinical trials. The newly published study ACCESS (Stroke 2003;34:1699) showed a clear beneficial effect of the angiotensin receptor blocker candesartan in the acute phase of stroke, but the trial was seriously underpowered.

The Scandinavian Candesartan Acute Stroke Trial (SCAST) is designed to provide reliable data on the effects of candesartan in a wide variety of patients with acute stroke (target recruitment 2,500). Patients presenting with acute stroke (<30 hours) and systolic blood pressure ≥140 mm Hg will be randomly assigned to candesartan 4 to 16 mg once daily or matching placebo for 7 days, followed by candesartan treatment for 6 months for patients who are hypertensive at the end of the treatment period (at clinician's discretion). Follow-up will be performed double-blind at 30 days, 3 months and 6 months.

The trial is co-ordinated from Ullevaal University Hospital in Oslo, Norway. Over 100 centres from Norway, Sweden, Denmark and Belgium have agreed to participate. Financial contributors: The Eastern Norway Regional Health Authority, AstraZeneca, and Ullevaal University Hospital (Oslo). AstraZeneca will supply drugs and placebo for the trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2500
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• Candesartan Cilexetil
4 mg on day 1; 8 mg on day 2; 16 mg on days 3-7
• Placebo
4 mg on day 1; 8 mg on day 2; 16 mg on days 3-7

Locations

Country	Name	City	State
Norway	Ullevaal University Hospital	Oslo

Sponsors (4)

Lead Sponsor	Collaborator
Ullevaal University Hospital	AstraZeneca, Southern-Eastern Norway Health Authorities RHF, Takeda

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death or major disability (defined by the modified Rankin scale) at 6 months		6 months	No
Primary	The composite event "vascular" death, myocardial infarction, or stroke during the first 6 months		6 months	No
Secondary	Scandinavian Stroke Scale score at 7 days		7 days	No
Secondary	Barthel Index score at 6 months		6 months	No
Secondary	EuroQol score at 6 months		6 months	No
Secondary	Mini-Mental State score at 6 months		6 months	No
Secondary	Death (all-cause death and "vascular" death)		6 months	No
Secondary	Recurrent stroke (ischaemic, haemorrhagic, or unspecified)		6 months	No
Secondary	Myocardial infarction		6 months	No
Secondary	Combination of the above events		6 months	No
Secondary	Symptomatic hypotension		7 days	Yes
Secondary	Renal failure		7 days	Yes

External Links

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