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12 February 2012
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| [ ...Back to search results ] | [ Print-friendly version ] |
| Continue Or Stop post-Stroke Antihypertensives Collaborative Study |
| ISRCTN | ISRCTN89712435 |
| ClinicalTrials.gov identifier | |
| 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 |
| 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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| © 2012 ISRCTN unless otherwise stated. | |
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