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Scandinavian Candesartan Acute Stroke Trial (SCAST)

Primary Purpose

Stroke

Status
Completed
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
Candesartan Cilexetil
Placebo
Sponsored by
Ullevaal University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Acute stroke, Elevated blood pressure, Blood pressure lowering treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ullevaal University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Candesartan Cilexetil

Placebo

Arm Description

Candesartan Cilexetil

Placebo

Outcomes

Primary Outcome Measures

Death or major disability (defined by the modified Rankin scale) at 6 months
The composite event "vascular" death, myocardial infarction, or stroke during the first 6 months

Secondary Outcome Measures

Scandinavian Stroke Scale score at 7 days
Barthel Index score at 6 months
EuroQol score at 6 months
Mini-Mental State score at 6 months
Death (all-cause death and "vascular" death)
Recurrent stroke (ischaemic, haemorrhagic, or unspecified)
Myocardial infarction
Combination of the above events
Symptomatic hypotension
Renal failure

Full Information

First Posted
July 6, 2005
Last Updated
June 30, 2011
Sponsor
Ullevaal University Hospital
Collaborators
Southern-Eastern Norway Health Authorities RHF, AstraZeneca, Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT00120003
Brief Title
Scandinavian Candesartan Acute Stroke Trial (SCAST)
Official Title
Scandinavian Candesartan Acute Stroke Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ullevaal University Hospital
Collaborators
Southern-Eastern Norway Health Authorities RHF, AstraZeneca, Takeda

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Acute stroke, Elevated blood pressure, Blood pressure lowering treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Candesartan Cilexetil
Arm Type
Experimental
Arm Description
Candesartan Cilexetil
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Candesartan Cilexetil
Intervention Description
4 mg on day 1; 8 mg on day 2; 16 mg on days 3-7
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
4 mg on day 1; 8 mg on day 2; 16 mg on days 3-7
Primary Outcome Measure Information:
Title
Death or major disability (defined by the modified Rankin scale) at 6 months
Time Frame
6 months
Title
The composite event "vascular" death, myocardial infarction, or stroke during the first 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Scandinavian Stroke Scale score at 7 days
Time Frame
7 days
Title
Barthel Index score at 6 months
Time Frame
6 months
Title
EuroQol score at 6 months
Time Frame
6 months
Title
Mini-Mental State score at 6 months
Time Frame
6 months
Title
Death (all-cause death and "vascular" death)
Time Frame
6 months
Title
Recurrent stroke (ischaemic, haemorrhagic, or unspecified)
Time Frame
6 months
Title
Myocardial infarction
Time Frame
6 months
Title
Combination of the above events
Time Frame
6 months
Title
Symptomatic hypotension
Time Frame
7 days
Title
Renal failure
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eivind Berge, MD, PhD
Organizational Affiliation
Ullevaal University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Per Morten Sandset, Prof
Organizational Affiliation
Ullevaal University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Povel Paus, MD, PhD
Organizational Affiliation
Ullevaal University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Ullevaal University Hospital
City
Oslo
ZIP/Postal Code
NO-0407
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
32640944
Citation
Wang X, Moullaali TJ, Li Q, Berge E, Robinson TG, Lindley R, Zheng D, Delcourt C, Arima H, Song L, Chen X, Yang J, Chalmers J, Anderson CS, Sandset EC. Utility-Weighted Modified Rankin Scale Scores for the Assessment of Stroke Outcome: Pooled Analysis of 20 000+ Patients. Stroke. 2020 Aug;51(8):2411-2417. doi: 10.1161/STROKEAHA.119.028523. Epub 2020 Jul 9.
Results Reference
derived
PubMed Identifier
26486868
Citation
Berge E, Cohen G, Lindley RI, Sandercock P, Wardlaw JM, Sandset EC, Whiteley W. Effects of Blood Pressure and Blood Pressure-Lowering Treatment During the First 24 Hours Among Patients in the Third International Stroke Trial of Thrombolytic Treatment for Acute Ischemic Stroke. Stroke. 2015 Dec;46(12):3362-9. doi: 10.1161/STROKEAHA.115.010319. Epub 2015 Oct 20.
Results Reference
derived
PubMed Identifier
25808741
Citation
Hornslien AG, Sandset EC, Igland J, Terent A, Boysen G, Bath PM, Murray GD, Berge E. Effects of candesartan in acute stroke on vascular events during long-term follow-up: results from the Scandinavian Candesartan Acute Stroke Trial (SCAST). Int J Stroke. 2015 Aug;10(6):830-5. doi: 10.1111/ijs.12477. Epub 2015 Mar 22.
Results Reference
derived
PubMed Identifier
25657183
Citation
Sandset EC, Jusufovic M, Sandset PM, Bath PM, Berge E; SCAST Study Group. Effects of blood pressure-lowering treatment in different subtypes of acute ischemic stroke. Stroke. 2015 Mar;46(3):877-9. doi: 10.1161/STROKEAHA.114.008512. Epub 2015 Feb 5.
Results Reference
derived
PubMed Identifier
25256183
Citation
Jusufovic M, Sandset EC, Bath PM, Berge E; Scandinavian Candesartan Acute Stroke Trial Study Group. Blood pressure-lowering treatment with candesartan in patients with acute hemorrhagic stroke. Stroke. 2014 Nov;45(11):3440-2. doi: 10.1161/STROKEAHA.114.006433. Epub 2014 Sep 25.
Results Reference
derived
PubMed Identifier
23660849
Citation
Hornslien AG, Sandset EC, Bath PM, Wyller TB, Berge E; Scandinavian Candesartan Acute Stroke Trial Study Group. Effects of candesartan in acute stroke on cognitive function and quality of life: results from the Scandinavian Candesartan Acute Stroke Trial. Stroke. 2013 Jul;44(7):2022-4. doi: 10.1161/STROKEAHA.113.001022. Epub 2013 May 9.
Results Reference
derived
PubMed Identifier
22627991
Citation
Sandset EC, Murray GD, Bath PM, Kjeldsen SE, Berge E; Scandinavian Candesartan Acute Stroke Trial (SCAST) Study Group. Relation between change in blood pressure in acute stroke and risk of early adverse events and poor outcome. Stroke. 2012 Aug;43(8):2108-14. doi: 10.1161/STROKEAHA.111.647362. Epub 2012 May 24.
Results Reference
derived
PubMed Identifier
21316752
Citation
Sandset EC, Bath PM, Boysen G, Jatuzis D, Korv J, Luders S, Murray GD, Richter PS, Roine RO, Terent A, Thijs V, Berge E; SCAST Study Group. The angiotensin-receptor blocker candesartan for treatment of acute stroke (SCAST): a randomised, placebo-controlled, double-blind trial. Lancet. 2011 Feb 26;377(9767):741-50. doi: 10.1016/S0140-6736(11)60104-9.
Results Reference
derived
PubMed Identifier
20854630
Citation
Sandset EC, Murray G, Boysen G, Jatuzis D, Korv J, Luders S, Richter PS, Roine RO, Terent A, Thijs V, Berge E; SCAST Study Group. Angiotensin receptor blockade in acute stroke. The Scandinavian Candesartan Acute Stroke Trial: rationale, methods and design of a multicentre, randomised- and placebo-controlled clinical trial (NCT00120003). Int J Stroke. 2010 Oct;5(5):423-7. doi: 10.1111/j.1747-4949.2010.00473.x.
Results Reference
derived
Links:
URL
http://www.scast.no
Description
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Scandinavian Candesartan Acute Stroke Trial (SCAST)

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