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Cervical Artery Dissection In Stroke Study
ISRCTN ISRCTN44555237
DOI 10.1186/ISRCTN44555237
ClinicalTrials.gov identifier NCT00238667
EudraCT number
Public title Cervical Artery Dissection In Stroke Study
Scientific title
Acronym CADISS
Serial number at source Protocol version 8.1 (19th Janurary 2010)
Study hypothesis Is therapy with anticoagulants better than treatment with antiplatelet agents for acute cervical artery dissection?

Please note that as of 26/05/10 this record has been updated to include changes in the protocol from v.3 (2007) to v.8.1 (2010). All updates can be found in the relevant field with the above update date. Please also note that the end date for this trial has been extended from 01/01/10 to 31/12/11.
Lay summary Not provided at time of registration
Ethics approval South West London 3 Research Ethics Committee (formerly known as Wandsworth REC) approved on the 22nd of December 2004 (ref: MREC 04/Q0803/215)
Study design Randomised multicentre open treatment trial
Countries of recruitment United Kingdom
Disease/condition/study domain Stroke, carotid artery dissection and vertebral artery dissection.
Participants - inclusion criteria 1. Extra cranial carotid or vertebral artery dissection with symptom onset within the last 7 days. This includes:
1.1. Ipsilateral Transient Ischemic Attack (TIA) or stroke with known date of onset
1.2. Ipsilateral Hornerís syndrome or neck pain with known date of onset
2. Imaging evidence of definite or probable dissection on Magnetic Resonance Imaging (MRI)/ Magnetic Resonance Angiography (MRA), Computed Tomographic Angiography (CTA) or ultrasound (patients can be initially randomised on ultrasound alone but subsequent MR or CTA confirmation is needed)
Participants - exclusion criteria 1. Intracranial cerebral artery dissection
2. Symptom onset >7 days
3. Contraindications to either antiplatelet agents or anticoagulation therapy, including active peptic ulceration, bleeding peptic ulcer within 1 year
4. Patient refusal to consent
5. Patients already taking antiplatelets or anticoagulants for other reasons e.g. prosthetic heart valves in whom the treatment cannot be replaced by either antiplatelets or anticoagulants
6. Women who are pregnant

Added 26/05/10:
7. Iatrogenic induced dissection
Anticipated start date 01/04/2006
Anticipated end date 31/12/2011
Status of trial Completed
Patient information material Patient information can be found at: http://www.sgul.ac.uk/dms/32EE671CBC5FEBFFE9794FC111A6BA0D.pdf
Target number of participants 250 in feasibility phase
Interventions This trial is currently recruiting in the United Kingdom as of 4 March 2007 - planning to extend internationally.

Patients will be randomised to either antiplatelet or anticoagulation therapy initially for at least 3 months, and thereafter at the discretion of the attending physician.

Arm 1: Antiplatelet therapy: Aspirin, dipyridamole or clopidogrel alone or in dual combination.
Arm 2: Anticoagulation with heparin (intravenous adminsitration, either unfractionated heparin or a therapeutic dose of low molecularweight heparin) followed by warfarin administered orally aiming for an coagulant response time (INR) in the range 2-3. Local protocols for heparin therapy can be used.

Treatment will be open-label. Low dose heparin prophylaxis for prevention of Deep Vein Thrombosis (DVT) is not a contra-indication, but its use should be recorded. Such prophylaxis may be continued after randomisation in the antiplatelet arm at the discretion of the local clinician. The doses of each drug used for antiplatelet therapy will be according to physician preference.
Primary outcome measure(s) Time to first ipsilateral stroke or death (any cause) within 3 months from randomisation
Secondary outcome measure(s) The following will be measured at the 3-month follow up:

1. Ipsilateral TIA, stroke or death (any cause) within 3 months from randomisation
2. Any TIA and stroke
3. Any stroke
4. Major bleeding
5. Presence of residual stenosis at 3 months (>50%)
6. Mortality
Sources of funding Stroke association (UK)
Trial website http://www.dissection.co.uk/
Publications 1. 2007 protocol in http://www.ncbi.nlm.nih.gov/pubmed/18705933
2. 2012 non-randomised arm results in http://www.ncbi.nlm.nih.gov/pubmed/22855862
Contact name Prof  Hugh  Markus
  Address Centre for Clinical Neuroscience
St George's University of London
Cranmer Terrace
  City/town London
  Zip/Postcode SW17 0RE
  Country United Kingdom
  Email hmarkus@sgul.ac.uk
Sponsor St George's University of London (UK)
  Address Research and Development Office
St George's University of London
Cranmer Terrace
  City/town London
  Zip/Postcode SW17 0RE
  Country United Kingdom
  Email cadiss@sgul.ac.uk
Date applied 04/03/2007
Last edited 19/09/2012
Date ISRCTN assigned 18/05/2007
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