Scandinavian Candesartan Acute Stroke Trial (SCAST) - Full Text View

Sponsor:	Ullevaal University Hospital
Collaborators:	Southern-Eastern Norway Health Authorities RHF AstraZeneca Takeda Pharmaceutical Company Limited
Information provided by:	Ullevaal University Hospital
ClinicalTrials.gov Identifier:	NCT00120003

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:

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Scandinavian Candesartan Acute Stroke Trial

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack

Drug Information available for: CV 11974 Candesartan cilexetil

U.S. FDA Resources

Further study details as provided by Ullevaal 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
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Candesartan Cilexetil: Experimental Candesartan Cilexetil	Drug: Candesartan Cilexetil 4 mg on day 1; 8 mg on day 2; 16 mg on days 3-7
Placebo: Placebo Comparator 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

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

Contacts

Contact: Eivind Berge, MD, PhD	+47 22 11 91 01	eivind.berge@medisin.uio.no
Contact: Rune Aakvik, MD	+47 23 01 66 60	rune.aakvik@medisin.uio.no

Locations

Norway
Ullevaal University Hospital	Recruiting
Oslo, Norway, NO-0407
Contact: Eivind Berge, MD, PhD +47 22 11 91 01 eivind.berge@medisin.uio.no
Contact: Else Charlotte Sandset, MD +47 23 01 66 60 e.c.sandset@medisin.uio.no
Principal Investigator: Eivind Berge, MD, PhD

Sponsors and Collaborators

Ullevaal University Hospital

Southern-Eastern Norway Health Authorities RHF

AstraZeneca

Takeda Pharmaceutical Company Limited

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:

Click here for more information about this trial This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Ullevaal University Hospital ( Director of Research Andreas Moan )
Study ID Numbers:	050321
Study First Received:	July 6, 2005
Last Updated:	February 13, 2009
ClinicalTrials.gov Identifier:	NCT00120003 History of Changes
Health Authority:	Norway: Norwegian Medicines Agency; Sweden: Medical Products Agency; Denmark: Danish Medicines Agency; Belgium: Directorate general for the protection of Public health: Medicines

Keywords provided by Ullevaal University Hospital:

Acute stroke
Elevated blood pressure
Blood pressure lowering treatment

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Cerebral Infarction
Stroke
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Cardiovascular Agents
Brain Diseases
Antihypertensive Agents

Cerebrovascular Disorders
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Candesartan cilexetil
Therapeutic Uses
Candesartan
Brain Ischemia
Cardiovascular Diseases
Brain Infarction

ClinicalTrials.gov processed this record on February 08, 2010