CADISS

Introduction

Dissection of the carotid and vertebral arteries is a major cause of stroke in persons <50 years of age, mainly due to embolism from clot sealing the tear.  At present physicians treat these patients with anticoagulants or antiplatelet drugs to prevent further stroke, but neither therapy is evidence- based.  Anticoagulants may be powerful anti-embolic agents but are also more hazardous than aspirin, and potentially could encourage further dissection.  Most published studies are flawed by retrospective data, with no reference to the number of patients in the original study cohort and do not include the critical principles of randomisation and ‘blinding’ of outcomes.

CADISS is a randomised multicentre prospective study comparing antiplatelet therapy with anticoagulation for patients with carotid and vertebral artery dissection.  Randomisation must be within seven days of onset of symptoms.

The aim of the study is to:

determine the feasibility of a clinical trial comparing antiplatelet therapy with anticoagulant therapy in the acute treatment of patients with cervical artery dissection.  Specifically to address whether:

(a) There are sufficient clinical endpoints to provide the power to determine treatment effect

(b) Adequate numbers of patients can be recruited

Please see the protocol for further information or contact the study co-ordinator.

News

27/11/09 - Our latest newsletter is available here.

27/11/09 - We have now reached 50 randomised patients.  Thank you to all the research teams recruiting to the randomised arm.

07/10/09 - The data and safety monitoring committee recently met, chaired by Professor Gary Ford.  No concerns were raised about outcomes in either treatment arm which was reassuring.

11/08/09 - Professor Markus has been appointed as the new chief investigator working alongside co-chief investigator Professor John Norris. Please ensure that your site file contains  a copy of the application form, MREC and MHRA approval letters.

03/07/09 - Our amended CTA, which now specifies the pharmaceutical forms of CADISS IMPs, has been reviewed and approved. Please ensure that your site file contains the application form, MREC and MHRA approval letters.

April 09 - Our latest newsletter is available.  If you would like to be added to the email distribution list, please contact cadiss@sgul.ac.uk

30/03/09 - CADISS recruitment period has been extended until 31st of December 2011. Please ensure that your site file contains the coverletter and MREC approval letter.

December 08- Our December newsletter is available.

August 08- Our August newsletter is available. 

17/03/08 - CADISS has been reopened at St George's.  Please ensure you do not start recruiting until you have implemented the new IMP managment procedures and have received a fully signed sponsorship agreement between your site and St George's. 

November 2007 - The CADISS Methodology has been published in the International Journal of Stroke.

18/10/07 - Our most recent substantial amendment has been approved.  Please ensure that you are using the latest versions of the protocol (Version 7), consent form, patient information sheet, GP letter.