StrokePhase 3NCT00120003
Scandinavian Candesartan Acute Stroke Trial (SCAST)
A Phase 3 study testing Candesartan Cilexetil in people with Stroke, run by Ullevaal University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Candesartan Cilexetil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,500 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2005to Sep 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Scandinavian Candesartan Acute Stroke Trial
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
Read the 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.
- Conditions
- Stroke
- Being tested
- Candesartan Cilexetil, Placebo
- Keywords
- Acute stroke, Elevated blood pressure, Blood pressure lowering treatment
- Medical subject headings
- Stroke, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Candesartan CilexetilDrug
4 mg on day 1; 8 mg on day 2; 16 mg on days 3-7
PlaceboDrug
4 mg on day 1; 8 mg on day 2; 16 mg on days 3-7
| Study group | Role | What they receive |
|---|---|---|
| Candesartan Cilexetil | Experimental | Candesartan Cilexetil Receives: Drug: Candesartan Cilexetil |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death or major disability (defined by the modified Rankin scale) at 6 months
Measured: 6 months
The composite event "vascular" death, myocardial infarction, or stroke during the first 6 months
Measured: 6 months
Secondary outcomes (10)
Scandinavian Stroke Scale score at 7 days
Measured: 7 days
Barthel Index score at 6 months
Measured: 6 months
EuroQol score at 6 months
Measured: 6 months
Mini-Mental State score at 6 months
Measured: 6 months
Death (all-cause death and "vascular" death)
Measured: 6 months
Recurrent stroke (ischaemic, haemorrhagic, or unspecified)
Measured: 6 months
Myocardial infarction
Measured: 6 months
Combination of the above events
Measured: 6 months
Symptomatic hypotension
Measured: 7 days
Renal failure
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2005 (estimated)
- Study startJun 2005
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Southern-Eastern Norway Health Authorities RHF, AstraZeneca, Takeda
- Investigators
- Eivind Berge, MD, PhD, Principal investigator, Ullevaal University HospitalPer Morten Sandset, Prof, Study chair, Ullevaal University HospitalPovel Paus, MD, PhD, Study director, Ullevaal University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00120003
- Sponsor's protocol ID
- 050321
- Status last verified
- Sep 2006
- First submitted
- 6 Jul 2005
- Last updated
- 1 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32640944Berge 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.
PubMed 26486868Hornslien 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.
PubMed 25808741Sandset 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.
PubMed 25657183Jusufovic 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.
PubMed 25256183Hornslien 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.
PubMed 23660849Sandset 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.
PubMed 22627991Sandset 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.
PubMed 21316752Sandset 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.
PubMed 20854630
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scandinavian Candesartan Acute Stroke Trial
- ClinicalTrials.gov ID
- NCT00120003
- Acronym / sponsor ID
- 050321
- Conditions
- Stroke
- Keywords
- Acute stroke, Elevated blood pressure, Blood pressure lowering treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Collaborators
- Southern-Eastern Norway Health Authorities RHF, AstraZeneca, Takeda
- Study start
- Jun 2005
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 14 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Candesartan Cilexetil | Experimental | Drug: Candesartan CilexetilCandesartan Cilexetil |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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.:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Candesartan Cilexetil4 mg on day 1; 8 mg on day 2; 16 mg on days 3-7 | Drug | Candesartan Cilexetil |
| Placebo4 mg on day 1; 8 mg on day 2; 16 mg on days 3-7 | Drug | Placebo |
Primary outcome
Death or major disability (defined by the modified Rankin scale) at 6 months
Time frame: 6 months
The composite event "vascular" death, myocardial infarction, or stroke during the first 6 months
Time frame: 6 months
10 secondary outcomes
Scandinavian Stroke Scale score at 7 days
Time frame: 7 days
Barthel Index score at 6 months
Time frame: 6 months
EuroQol score at 6 months
Time frame: 6 months
Mini-Mental State score at 6 months
Time frame: 6 months
Death (all-cause death and "vascular" death)
Time frame: 6 months
Recurrent stroke (ischaemic, haemorrhagic, or unspecified)
Time frame: 6 months
Myocardial infarction
Time frame: 6 months
Combination of the above events
Time frame: 6 months
Symptomatic hypotension
Time frame: 7 days
Renal failure
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2011.
- Derived from this study: PubMed 32640944Wang 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.
- Derived from this study: PubMed 26486868Berge 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.
- Derived from this study: PubMed 25808741Hornslien 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.
- Derived from this study: PubMed 25657183Sandset 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.
- Derived from this study: PubMed 25256183Jusufovic 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.
- Derived from this study: PubMed 23660849Hornslien 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.
- Derived from this study: PubMed 22627991Sandset 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.
- Derived from this study: PubMed 21316752Sandset 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.
- Derived from this study: PubMed 20854630Sandset 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.
- Click here for more information about this trialLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eivind Berge, MD, PhD principal investigator
Ullevaal University Hospital
Per Morten Sandset, Prof study chair
Ullevaal University Hospital
Povel Paus, MD, PhD study director
Ullevaal University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Candesartan Cilexetil in people with Stroke, run by Ullevaal University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death or major disability (defined by the modified Rankin scale) at 6 months (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00120003, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2011.