Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-26 @ 9:31 PM
Study NCT ID:
NCT00120003
Status:
COMPLETED
Last Update Posted:
2011-07-01
First Post:
2005-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Scandinavian Candesartan Acute Stroke Trial (SCAST)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C077793', 'term': 'candesartan cilexetil'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-09', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-30', 'studyFirstSubmitDate': '2005-07-06', 'studyFirstSubmitQcDate': '2005-07-06', 'lastUpdatePostDateStruct': {'date': '2011-07-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death or major disability (defined by the modified Rankin scale) at 6 months', 'timeFrame': '6 months'}, {'measure': 'The composite event "vascular" death, myocardial infarction, or stroke during the first 6 months', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Scandinavian Stroke Scale score at 7 days', 'timeFrame': '7 days'}, {'measure': 'Barthel Index score at 6 months', 'timeFrame': '6 months'}, {'measure': 'EuroQol score at 6 months', 'timeFrame': '6 months'}, {'measure': 'Mini-Mental State score at 6 months', 'timeFrame': '6 months'}, {'measure': 'Death (all-cause death and "vascular" death)', 'timeFrame': '6 months'}, {'measure': 'Recurrent stroke (ischaemic, haemorrhagic, or unspecified)', 'timeFrame': '6 months'}, {'measure': 'Myocardial infarction', 'timeFrame': '6 months'}, {'measure': 'Combination of the above events', 'timeFrame': '6 months'}, {'measure': 'Symptomatic hypotension', 'timeFrame': '7 days'}, {'measure': 'Renal failure', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acute stroke', 'Elevated blood pressure', 'Blood pressure lowering treatment'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '32640944', 'type': 'DERIVED', '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.'}, {'pmid': '26486868', 'type': 'DERIVED', '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.'}, {'pmid': '25808741', 'type': 'DERIVED', '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.'}, {'pmid': '25657183', 'type': 'DERIVED', '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.'}, {'pmid': '25256183', 'type': 'DERIVED', '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.'}, {'pmid': '23660849', 'type': 'DERIVED', '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.'}, {'pmid': '22627991', 'type': 'DERIVED', '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.'}, {'pmid': '21316752', 'type': 'DERIVED', '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.'}, {'pmid': '20854630', 'type': 'DERIVED', '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.'}], 'seeAlsoLinks': [{'url': 'http://www.scast.no', 'label': 'Click here for more information about this trial'}]}, 'descriptionModule': {'briefSummary': '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.\n\nHypothesis:\n\nAT1 receptor blockade with candesartan in acute stroke will:\n\n1. reduce the risk of death or major disability at 6 months by a 6% absolute risk reduction, relative to placebo.\n2. 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', 'detailedDescription': "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.\n\nThe 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical stroke syndrome with limb paresis, not likely to represent a transient ischaemic attack or non-stroke pathology (e.g. cerebral tumour)\n* Systolic blood pressure ≥ 140 mm Hg\n* 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.\n* Consent (subsidiary, assent from legal acceptable representative, or waiver of consent)\n* Age \\>18 years\n\nExclusion Criteria:\n\n* Markedly reduced consciousness (i.e. Scandinavian Stroke Scale consciousness score ≤ 2)\n* Patient already receiving AT1 receptor blocker\n* Contraindication to treatment with AT1 receptor blocker, e.g.:\n\n * known renal failure (women: creatinine ≥ 150 µmol/L; men: ≥ 180 µmol/L)\n * previously diagnosed bilateral renal artery stenosis\n * previously diagnosed high-grade aortic stenosis\n * previously diagnosed seriously impaired liver function and/or cholestasis\n * known intolerance to candesartan or other tablet ingredients\n* 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)\n* 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)\n* Other serious or life-threatening disease before the stroke:\n* Patient severely mentally or physically disabled (e.g. Mini Mental Status score \\< 20, or modified Rankin Scale score ≥ 4)\n* Life expectancy \\< 12 months\n* Patient unavailable for follow-up (e.g. no fixed address)\n* Pregnant or breast-feeding woman"}, 'identificationModule': {'nctId': 'NCT00120003', 'briefTitle': 'Scandinavian Candesartan Acute Stroke Trial (SCAST)', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Scandinavian Candesartan Acute Stroke Trial', 'orgStudyIdInfo': {'id': '050321'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Candesartan Cilexetil', 'description': 'Candesartan Cilexetil', 'interventionNames': ['Drug: Candesartan Cilexetil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Candesartan Cilexetil', 'type': 'DRUG', 'description': '4 mg on day 1; 8 mg on day 2; 16 mg on days 3-7', 'armGroupLabels': ['Candesartan Cilexetil']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '4 mg on day 1; 8 mg on day 2; 16 mg on days 3-7', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NO-0407', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Ullevaal University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Eivind Berge, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ullevaal University Hospital'}, {'name': 'Per Morten Sandset, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Ullevaal University Hospital'}, {'name': 'Povel Paus, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ullevaal University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ullevaal University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Southern-Eastern Norway Health Authorities RHF', 'class': 'UNKNOWN'}, {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, {'name': 'Takeda', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Director of Research Andreas Moan', 'oldOrganization': 'Ullevaal University Hospital'}}}}