Scandinavian Candesartan Acute Stroke Trial (SCAST)

This study has been completed.
Sponsor:
Collaborators:
Southern-Eastern Norway Health Authorities RHF
AstraZeneca
Takeda
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00120003
First received: July 6, 2005
Last updated: June 30, 2011
Last verified: September 2006
  Purpose

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

Condition Intervention Phase
Stroke
Drug: Candesartan Cilexetil
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Scandinavian Candesartan Acute Stroke Trial

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Death or major disability (defined by the modified Rankin scale) at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The composite event "vascular" death, myocardial infarction, or stroke during the first 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Scandinavian Stroke Scale score at 7 days [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Barthel Index score at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • EuroQol score at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Mini-Mental State score at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Death (all-cause death and "vascular" death) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Recurrent stroke (ischaemic, haemorrhagic, or unspecified) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Myocardial infarction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Combination of the above events [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Symptomatic hypotension [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • Renal failure [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2500
Study Start Date: June 2005
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo
Drug: Placebo
4 mg on day 1; 8 mg on day 2; 16 mg on days 3-7

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00120003

Locations
Norway
Ullevaal University Hospital
Oslo, Norway, NO-0407
Sponsors and Collaborators
Ullevaal University Hospital
Southern-Eastern Norway Health Authorities RHF
AstraZeneca
Takeda
Investigators
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
  More Information

Additional Information:
No publications provided by Oslo University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director of Research Andreas Moan, Ullevaal University Hospital
ClinicalTrials.gov Identifier: NCT00120003     History of Changes
Other Study ID Numbers: 050321
Study First Received: July 6, 2005
Last Updated: June 30, 2011
Health Authority: Norway: Norwegian Medicines Agency
Sweden: Medical Products Agency
Denmark: Danish Medicines Agency
Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by Oslo University Hospital:
Acute stroke
Elevated blood pressure
Blood pressure lowering treatment

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Candesartan
Candesartan cilexetil
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014