Cervical Artery Dissection In Stroke Study

Not Applicable

Completed

• Conditions: Stroke, carotid artery dissection and vertebral artery dissection; Circulatory System; Cardiovascular

• Registration Number: ISRCTN44555237
• Lead Sponsor: St George's University of London (UK)

Brief Summary

2007 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/18705933 2012 non-randomised arm results in: http://www.ncbi.nlm.nih.gov/pubmed/22855862 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25684164 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30801621

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-05-18
• Study Completion: 2011-12-31
• Last Update Posted: 25 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 250

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)

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to first ipsilateral stroke or death (any cause) within 3 months from randomisation

Secondary Outcome Measures

Name	Time	Method
<br> The following will be measured at the 3-month follow up:<br><br> 1. Ipsilateral TIA, stroke or death (any cause) within 3 months from randomisation<br> 2. Any TIA and stroke<br> 3. Any stroke<br> 4. Major bleeding<br> 5. Presence of residual stenosis at 3 months (>50%)<br> 6. Mortality<br>