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Continue Or Stop post-Stroke Antihypertensives Collaborative Study
ISRCTN ISRCTN89712435
DOI 10.1186/ISRCTN89712435
ClinicalTrials.gov identifier
EudraCT number
Public title Continue Or Stop post-Stroke Antihypertensives Collaborative Study
Scientific title A multicentre, prospective, randomised, open, blinded-endpoint study to assess whether existing antihypertensive therapy should be continued or discontinued within 24-hours of stroke onset and for the subsequent two weeks
Acronym COSSACS
Serial number at source 2134
Study hypothesis Up to 40% of acute stroke patients on hospital admission are already taking antihypertensive therapy, and most will develop elevated blood pressure levels as an acute complication of the stroke. However, no guidelines exist as to whether antihypertensive therapy should be continued or discontinued following acute stroke. The Continue Or Stop post-Stroke Antihypertensives Collaborative Study (COSSACS) is a multicentre, prospective, randomised, open, blinded-endpoint study to assess whether existing antihypertensive therapy should be continued or discontinued within 24-hours of stroke onset and for the subsequent two weeks.

A study population of 2900 patients with both cerebral infarction and haemorrhage on antihypertensive treatment at hospital admission will be recruited giving the study a 90% power at the 5% significance level to detect a relative reduction of 10% (absolute risk reduction of 6%) in death and dependency between continuation and discontinuation groups at two weeks. Non-dysphagic, hospital-admitted stroke patients will be recruited within 24 hours of stroke onset and also within 24 hours of last dose of pre-existing antihypertensive therapy.

Baseline investigations will include: blood pressure measurement using UA-767 monitor, modified Rankin Score, Barthel Index, National Institutes of Health Stroke Score and Oxfordshire Community Stroke Project Classification. Patients will be centrally randomised by telephone to continue or discontinue pre-existing antihypertensive treatment for a two-week period. Blood pressure, modified Rankin Score, Barthel Index and National Institutes of Health Stroke Score will be repeated at 2 weeks by an observer blinded to the randomised group. Mortality and health-related quality of life outcomes will be centrally recorded at 6 months.
Lay summary
Ethics approval Trent Research Ethics Committee approved on the 22nd August 2002 (ref: 02/4/051)
Study design Multicentre randomised interventional treatment trial
Countries of recruitment United Kingdom
Disease/condition/study domain Topic: Stroke Research Network; Subtopic: Acute Care; Disease: Therapy type
Participants - inclusion criteria 1. Aged greater than or equal to 18 years, either sex
2. Stroke onset greater than or equal to 48 hours (for suspected stroke, onset time is last time patient was asymptomatic)
3. Clinical diagnosis of suspected stroke by neuroimaging before or after study entry to exclude non-stroke diagnoses and define stroke type
4. Currently receiving antihypertensive treatment and within 48 hours or last dose
5. Informed patient consent or relative/carer consent
Participants - exclusion criteria 1. Hypertensive encephalopathy
2. Hypertension greater than 200/120 mmHg in association with intracerebral haemorrhage
3. Co-existing cardiac or vascular emergency
4. Contraindications to stopping antihypertensive therapy
5. Impaired conscious level
6. Dysphagia
7. Premorbid dependence
8. Co-existing life-threatening condition with life expectancy less than 6 months
9. Females of child-bearing potential
10. Non-stroke diagnoses
Anticipated start date 01/01/2001
Anticipated end date 31/03/2009
Status of trial Completed
Patient information material
Target number of participants Planned sample size: 3000; UK sample size: 3000
Interventions Baseline investigations include blood pressure measurement using UA-767 monitor, modified Rankin Score, Barthel Index, National Institutes of Health Stroke Score and Oxfordshire Community Stroke Project Classification.

Patients will be centrally randomised by telephone to continue or discontinue pre-existing antihypertensive treatment for a two-week period.

Blood pressure, modified Rankin Score, Barthel Index and National Institutes of Health Stroke Score will be repeated at 2 weeks by an observer blinded to the randomised group. Mortality and health-related quality of life outcomes will be centrally recorded at 6 months.

Follow-up length: 6 months
Study entry: single randomisation only
Primary outcome measure(s) Death or dependancy (modified Rankin Score greater than 3) at 2 weeks post-randomisation
Secondary outcome measure(s) Early outcomes, measured at 2 weeks and 6 months:
1. Neurological deterioration
2. Functional status
3. Blood pressure changes from admission and discharge

Late outcomes:
4. Death and dependency
5. Fatal and non-fatal stroke recurrence
6. Functional status
7. Health-related quality of life
Sources of funding Health Foundation (UK)
Trial website
Publications 1. 2005 protocol in http://www.ncbi.nlm.nih.gov/pubmed/15662235
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20621562
Contact name Prof  Thompson G  Robinson
  Address Department of Cardiovascular Sciences
University of Leicester
Robert Kilpatrick Clinical Sciences Building
Leicester Royal Infirmary
  City/town Leicester
  Zip/Postcode LE2 7LX
  Country United Kingdom
  Email tgr2@leicester.ac.uk
Sponsor University Hospitals of Leicester NHS Trust (UK)
  Address Leicester Royal Infirmary
Infirmary Square
  City/town Leicester
  Zip/Postcode LE1 5WW
  Country United Kingdom
  Sponsor website: http://www.uhl-tr.nhs.uk/
Date applied 28/05/2010
Last edited 19/11/2010
Date ISRCTN assigned 28/05/2010
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