Condition category
Circulatory System
Date applied
28/05/2010
Date assigned
28/05/2010
Last edited
27/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Thompson G Robinson

ORCID ID

Contact details

Department of Cardiovascular Sciences
University of Leicester
Robert Kilpatrick Clinical Sciences Building
Leicester Royal Infirmary
Leicester
LE2 7LX
United Kingdom
-
tgr2@leicester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2134

Study information

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

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.

Ethics approval

Trent Research Ethics Committee, 22/08/2002, ref: 02/4/051

Study design

Multicentre randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Phase III

Drug names

Primary outcome measures

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 trial start date

01/01/2001

Overall trial end date

31/03/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 3000; UK sample size: 3000

Participant 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

Recruitment start date

01/01/2001

Recruitment end date

31/03/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Leicester
Leicester
LE2 7LX
United Kingdom

Sponsor information

Organisation

University Hospitals of Leicester NHS Trust (UK)

Sponsor details

Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.uhl-tr.nhs.uk/

Funders

Funder type

Charity

Funder name

Health Foundation (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2005 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/15662235
2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20621562
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25908462

Publication citations

  1. Protocol

    COSSACS (Continue or Stop post-Stroke Antihypertensives Collaborative Study): rationale and design., J. Hypertens., 2005, 23, 2, 455-458.

  2. Results

    Robinson TG, Potter JF, Ford GA, Bulpitt CJ, Chernova J, Jagger C, James MA, Knight J, Markus HS, Mistri AK, Poulter NR, , Effects of antihypertensive treatment after acute stroke in the Continue or Stop Post-Stroke Antihypertensives Collaborative Study (COSSACS): a prospective, randomised, open, blinded-endpoint trial., Lancet Neurol, 2010, 9, 8, 767-775, doi: 10.1016/S1474-4422(10)70163-0.

  3. Results

    Manning LS, Mistri AK, Potter J, Rothwell PM, Robinson TG, Short-Term Blood Pressure Variability in Acute Stroke: Post Hoc Analysis of the Controlling Hypertension and Hypotension Immediately Post Stroke and Continue or Stop Post-Stroke Antihypertensives Collaborative Study Trials, Stroke, 2015, doi: 10.1161/STROKEAHA.115.009078.

Additional files

Editorial Notes