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21 May 2012
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| [ ...Back to search results ] | [ Print-friendly version ] |
| Cervical Artery Dissection In Stroke Study |
| ISRCTN | ISRCTN44555237 |
| ClinicalTrials.gov identifier | NCT00238667 |
| 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 | |
| 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 Horner’s 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. Latrogenic 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 | 2007 protocol in http://www.ncbi.nlm.nih.gov/pubmed/18705933 |
| 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 |
| 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 |
| cadiss@sgul.ac.uk | |
| Date applied | 04/03/2007 |
| Last edited | 24/11/2010 |
| Date ISRCTN assigned | 18/05/2007 |
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