Cervical Artery Dissection In Stroke Study
| ISRCTN | ISRCTN44555237 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44555237 |
| ClinicalTrials.gov number | NCT00238667 |
| Secondary identifying numbers | Protocol version 8.1 (19th Janurary 2010) |
- Submission date
- 04/03/2007
- Registration date
- 18/05/2007
- Last edited
- 27/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof Hugh Markus
Scientific
Scientific
Centre for Clinical Neuroscience
St George's University of London
Cranmer Terrace
London
SW17 0RE
United Kingdom
| hmarkus@sgul.ac.uk |
Study information
| Study design | Randomised multicentre open treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Patient information can be found at: http://www.sgul.ac.uk/dms/32EE671CBC5FEBFFE9794FC111A6BA0D.pdf |
| Scientific title | Cervical Artery Dissection In Stroke Study |
| Study acronym | CADISS |
| Study hypothesis | Is therapy with anticoagulants better than treatment with antiplatelet agents for acute cervical artery dissection? On 26/05/10 this record was 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 overall trial end date was changed from 01/01/10 to 31/12/11. |
| Ethics approval(s) | South West London 3 Research Ethics Committee (formerly known as Wandsworth REC), 22/12/2004, ref: MREC 04/Q0803/215 |
| Condition | Stroke, carotid artery dissection and vertebral artery dissection |
| Intervention | This trial is currently recruiting in the United Kingdom as of 04/03/2007 - 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | anticoagulants, antiplatelet agents |
| Primary outcome measure | Time to first ipsilateral stroke or death (any cause) within 3 months from randomisation |
| Secondary outcome measures | 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 |
| Overall study start date | 01/04/2006 |
| Overall study end date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 250 in feasibility phase |
| Participant 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) |
| Participant 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 |
| Recruitment start date | 01/04/2006 |
| Recruitment end date | 31/12/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Centre for Clinical Neuroscience
London
SW17 0RE
United Kingdom
SW17 0RE
United Kingdom
Sponsor information
St George's University of London (UK)
University/education
University/education
Research and Development Office
St George's University of London
Cranmer Terrace
London
SW17 0RE
England
United Kingdom
| cadiss@sgul.ac.uk | |
"ROR" |
https://ror.org/040f08y74 |
Funders
Funder type
Charity
Stroke association (UK)
Private sector organisation / Associations and societies (private and public)
Private sector organisation / Associations and societies (private and public)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/11/2007 | Yes | No | |
| Results article | non-randomised arm results | 14/08/2012 | Yes | No | |
| Results article | results | 01/04/2015 | Yes | No | |
| Results article | results | 01/06/2019 | Yes | No |
Editorial Notes
27/02/2019: Publication reference added.
