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Scandinavian Candesartan Acute Stroke Trial (SCAST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00120003
Recruitment Status : Completed
First Posted : July 14, 2005
Last Update Posted : July 1, 2011
Southern-Eastern Norway Health Authorities RHF
Information provided by:
Oslo University Hospital

Brief 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.


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

Condition or disease Intervention/treatment Phase
Stroke Drug: Candesartan Cilexetil Drug: Placebo Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Scandinavian Candesartan Acute Stroke Trial
Study Start Date : June 2005
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Candesartan Cilexetil
Candesartan Cilexetil
Drug: Candesartan Cilexetil
4 mg on day 1; 8 mg on day 2; 16 mg on days 3-7

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

Primary Outcome Measures :
  1. Death or major disability (defined by the modified Rankin scale) at 6 months [ Time Frame: 6 months ]
  2. The composite event "vascular" death, myocardial infarction, or stroke during the first 6 months [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Scandinavian Stroke Scale score at 7 days [ Time Frame: 7 days ]
  2. Barthel Index score at 6 months [ Time Frame: 6 months ]
  3. EuroQol score at 6 months [ Time Frame: 6 months ]
  4. Mini-Mental State score at 6 months [ Time Frame: 6 months ]
  5. Death (all-cause death and "vascular" death) [ Time Frame: 6 months ]
  6. Recurrent stroke (ischaemic, haemorrhagic, or unspecified) [ Time Frame: 6 months ]
  7. Myocardial infarction [ Time Frame: 6 months ]
  8. Combination of the above events [ Time Frame: 6 months ]
  9. Symptomatic hypotension [ Time Frame: 7 days ]
  10. Renal failure [ Time Frame: 7 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00120003

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Ullevaal University Hospital
Oslo, Norway, NO-0407
Sponsors and Collaborators
Ullevaal University Hospital
Southern-Eastern Norway Health Authorities RHF
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Principal Investigator: Eivind Berge, MD, PhD Ullevaal University Hospital
Study Chair: Per Morten Sandset, Prof Ullevaal University Hospital
Study Director: Povel Paus, MD, PhD Ullevaal University Hospital

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Director of Research Andreas Moan, Ullevaal University Hospital Identifier: NCT00120003     History of Changes
Other Study ID Numbers: 050321
First Posted: July 14, 2005    Key Record Dates
Last Update Posted: July 1, 2011
Last Verified: September 2006
Keywords provided by Oslo University Hospital:
Acute stroke
Elevated blood pressure
Blood pressure lowering treatment
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Candesartan cilexetil
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action