Continue Or Stop post-Stroke Antihypertensives Collaborative Study
| ISRCTN | ISRCTN89712435 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89712435 |
| Secondary identifying numbers | 2134 |
- Submission date
- 28/05/2010
- Registration date
- 28/05/2010
- Last edited
- 27/04/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Thompson G Robinson
Scientific
Scientific
Department of Cardiovascular Sciences
University of Leicester
Robert Kilpatrick Clinical Sciences Building
Leicester Royal Infirmary
Leicester
LE2 7LX
United Kingdom
| tgr2@leicester.ac.uk |
Study information
| Study design | Multicentre randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Study acronym | COSSACS |
| Study objectives | 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. |
| Ethics approval(s) | Trent Research Ethics Committee, 22/08/2002, ref: 02/4/051 |
| Health condition(s) or problem(s) studied | Topic: Stroke Research Network; Subtopic: Acute Care; Disease: Therapy type |
| Intervention | 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 |
| Intervention type | Other |
| Primary outcome measure | Death or dependancy (modified Rankin Score greater than 3) at 2 weeks post-randomisation |
| Secondary outcome measures | 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 |
| Overall study start date | 01/01/2001 |
| Completion date | 31/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned sample size: 3000; UK sample size: 3000 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2001 |
| Date of final enrolment | 31/03/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Leicester
Leicester
LE2 7LX
United Kingdom
LE2 7LX
United Kingdom
Sponsor information
University Hospitals of Leicester NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
England
United Kingdom
| Website | http://www.uhl-tr.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/02fha3693 |
Funders
Funder type
Charity
Health Foundation (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/02/2005 | Yes | No | |
| Results article | results | 01/08/2010 | Yes | No | |
| Results article | results | 01/06/2015 | Yes | No |
