Acute Candesartan Cilexetil Outcomes Stroke Trial (ACCOST)
3 other identifiers
interventional
50
1 country
1
Brief Summary
The aim of this study is to determine whether it is safe and effective to give the Angiotensin Receptor Blocker (ARB) Candesartan within the first 72 hours following acute stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2004
Typical duration for phase_4
1 active site
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
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 18, 2005
CompletedFirst Posted
Study publicly available on registry
April 19, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedSeptember 13, 2006
September 1, 2006
April 18, 2005
September 11, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mortality (all causes)
Mortality (vascular causes)
Secondary Outcomes (2)
Neurological Recovery (NIHSS [National Institutes of Health Stroke Scale])
Functional Recovery (Modified Rankin/Barthel)
Interventions
Eligibility Criteria
You may qualify if:
- Acute ischaemic stroke \<72 hours from symptom onset (CT proven)
- Medically stable with no evidence of acute infection and not receiving antibiotic therapy
- Neurologically stable (no progression on NIHSS)
- Able to swallow unthickened fluids safely
- Mean BP (blood pressure) \>120/70 in unaffected arm
You may not qualify if:
- Previous severe disability (Modified Rankin Score \>2)
- Nursing home residents
- Previous history of congestive heart failure requiring treatment with ACE-Inhibitors or angiotensin receptor blockers
- Renal impairment (creatinine \>200 mcgmol/L)
- Women of child bearing potential
- Minors \<18 years of age
- History of dementia without ability to consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- City Hospitals Sunderland NHS Foundation Trustlead
- Takedacollaborator
Study Sites (1)
Sunderland Royal Hospital
Sunderland, Tyne and Wear, SR4 7TP, United Kingdom
Related Publications (3)
Heart Outcomes Prevention Evaluation Study Investigators; Yusuf S, Sleight P, Pogue J, Bosch J, Davies R, Dagenais G. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. N Engl J Med. 2000 Jan 20;342(3):145-53. doi: 10.1056/NEJM200001203420301.
PMID: 10639539BACKGROUNDPROGRESS Collaborative Group. Randomised trial of a perindopril-based blood-pressure-lowering regimen among 6,105 individuals with previous stroke or transient ischaemic attack. Lancet. 2001 Sep 29;358(9287):1033-41. doi: 10.1016/S0140-6736(01)06178-5.
PMID: 11589932BACKGROUNDSchrader J, Luders S, Kulschewski A, Berger J, Zidek W, Treib J, Einhaupl K, Diener HC, Dominiak P; Acute Candesartan Cilexetil Therapy in Stroke Survivors Study Group. The ACCESS Study: evaluation of Acute Candesartan Cilexetil Therapy in Stroke Survivors. Stroke. 2003 Jul;34(7):1699-703. doi: 10.1161/01.STR.0000075777.18006.89. Epub 2003 Jun 19.
PMID: 12817109BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher S Gray, MD
University of Newcastle Upon-Tyne
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 18, 2005
First Posted
April 19, 2005
Study Start
December 1, 2004
Study Completion
September 1, 2007
Last Updated
September 13, 2006
Record last verified: 2006-09