NCT00120003

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:

  1. 1.reduce the risk of death or major disability at 6 months by a 6% absolute risk reduction, relative to placebo.
  2. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for phase_3 stroke

Timeline
Completed

Started Jun 2005

Typical duration for phase_3 stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 6, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 14, 2005

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

July 1, 2011

Status Verified

September 1, 2006

Enrollment Period

5.3 years

First QC Date

July 6, 2005

Last Update Submit

June 30, 2011

Conditions

Stroke

Keywords

Acute strokeElevated blood pressureBlood pressure lowering treatment

Outcome Measures

Primary Outcomes (2)

  • Death or major disability (defined by the modified Rankin scale) at 6 months

    6 months

  • The composite event "vascular" death, myocardial infarction, or stroke during the first 6 months

    6 months

Secondary Outcomes (10)

  • Scandinavian Stroke Scale score at 7 days

    7 days

  • Barthel Index score at 6 months

    6 months

  • EuroQol score at 6 months

    6 months

  • Mini-Mental State score at 6 months

    6 months

  • Death (all-cause death and "vascular" death)

    6 months

  • +5 more secondary outcomes

Study Arms (2)

Candesartan Cilexetil

EXPERIMENTAL

Candesartan Cilexetil

Drug: Candesartan Cilexetil

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Candesartan CilexetilDRUG

4 mg on day 1; 8 mg on day 2; 16 mg on days 3-7

Candesartan Cilexetil
PlaceboDRUG

4 mg on day 1; 8 mg on day 2; 16 mg on days 3-7

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ullevaal University Hospital

Oslo, NO-0407, Norway

Location

Related Publications (9)

  • 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: 32640944DERIVED

  • 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: 26486868DERIVED

  • 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: 25808741DERIVED

  • 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: 25657183DERIVED

  • 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: 25256183DERIVED

  • 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: 23660849DERIVED

  • 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: 22627991DERIVED

  • 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: 21316752DERIVED

  • 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.

    PMID: 20854630DERIVED

Related Links

MeSH Terms

Conditions

StrokeHypertension

Interventions

candesartan cilexetil

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Eivind Berge, MD, PhD

    Ullevaal University Hospital

    PRINCIPAL INVESTIGATOR

  • Per Morten Sandset, Prof

    Ullevaal University Hospital

    STUDY CHAIR

  • Povel Paus, MD, PhD

    Ullevaal University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 6, 2005

First Posted

July 14, 2005

Study Start

June 1, 2005

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

July 1, 2011

Record last verified: 2006-09

Locations

NO(1)