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Stroke Interventions in Clinical Trials
Printable Version
COSSACS
Continue Or Stop post-Stroke Antihypertensives Collaborative Study



Principal Investigator
Thompson G Robinson

PI Address
Leicester General Hospital
Gwendolen Road
Leicester LE5 4PW England

Contact Address
N. Shah, MD
P. Eames, MD
Dept. of Cardiovascular Sciences
Aging and Stroke Research Group
University of Leicaster, UK

Anne Moore on am169@le.ac.uk

Contact Email
am169@le.ac.uk

Sponsor



Study Size Actual:763
Study Size Planned:2900
Centers Actual:68
Centers Planned:50
Max Time from onset:24 Hours
Follow-up Duration:6 Months
ISRCTN#UK CRIN 2134
Status:
COSSACS closed to recruitment on 31 March 2009, and last follow-up was completed on 31 October 2009. A total of 763 patients were recruited, and it is anticipated that the results will be presented at the European Stroke Conference in Barcelona in May 2010.

Purpose:
To determine whether antihypertensive therapy should be continued or discontinued in the acute situation.

Interventions:
Antihypertensives
This category includes all BP lowering drugs in stroke prevention trials

Location(s):
UK

Year Started: 2002
Year Finished: 2009
Year Presented: 2010

Design:
Multi-centre, prospective, randomised, open, blinded-endpoint study.

Inclusion Criteria
Patients within 24 hours of acute ischemic or hemorrhagic stroke and within 24 hours of last dose of antihypertensive therapy.

Exclusion Criteria
Unconscious or dysphagic patients, and patients with urgent indications for or contraindications to stopping antihypertensive therapy will be excluded from the study.

Patient Involvement:
Patients will receive antihypertensive therapy for a 2-week period, after which administration will be at the discretion of individual clinicians. All routine aspects of patient management with respect to investigation, acute management and rehabilitation will be continued as standard local practice.

Primary Outcome:
Primary outcome will be the mortality or dependent rate (Modified Rankin Score >2) at 14 days post-stroke.

Secondary Outcome:
Early secondary outcome measures will include neurological and functional status, discharge destination and blood pressure levels (compared to admission) at 2 weeks. Late secondary outcome measures will include death and dependency, discharge destination and health-related quality of life at 6 months post-stroke.

Source of Information:
Presented at the 30th International Stroke Conference [February 2005].
Stroke 2004 35: e359 - e368.
Trial Web site.
Presented at the European Stroke Conference [May 2005].
Presented at the 2007 International Stroke Conference [February 2007].
Presented at the 2008 International Stroke Conference (February 2008).
Presented atESC 2010 [May 2010].

Web Links and Publications:
COSSACS Web site.

The Continue Or Stop post-Stroke Antihypertensives Collaborative Study (COSSACS).
Ongoing Clinical Trials Session, 28th International Stroke Conference, 2003 [PDF Format]

COSSACS ESC 2010

This information last updated on: 6/18/2010

Reviewed on: 02/16/2010.

UID: 485

   

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