• Int J Stroke · Nov 2007

    Randomized Controlled Trial Multicenter Study Comparative Study

    Antiplatelet therapy vs. anticoagulation in cervical artery dissection: rationale and design of the Cervical Artery Dissection in Stroke Study (CADISS).

    • Cervical Artery Dissection in Stroke Study Trial Investigators.
    • Clinical Neuroscience, St George's University of London, Cranmer Terrace, Tooting, London SW17 0RE, UK. hmarkus@sgul.ac.uk
    • Int J Stroke. 2007 Nov 1; 2 (4): 292-6.

    RationaleCervical artery dissection is an important cause of stroke in the young. It can present with local symptoms or stroke/transient ischaemic attacks. Following presentation there is a risk of stroke, particularly in the first month following presentation. The mechanism of stroke is believed to be thromboembolic in the majority of cases. Many clinicians anticoagulate patients with cervical dissection for 3-6 months. This is not evidence based and is supported by a paucity of data and no data from randomised control trials.AimsCADISS is a prospective multicentre randomised-controlled trial in acute (within 7 days of onset) carotid and vertebral artery dissection. Intracerebral artery dissection is excluded.DesignPatients are randomised to antiplatelet therapy (aspirin, dipyridamole or clopidogrel alone or in dual combination) or anticoagulation therapy [heparin followed by warfarin aiming for an International Normalised Ratio (INR) in the range 2-3] for at least 3 months. Treatment is open-label.Study OutcomeThe primary end-point is ipsilateral stroke or death within 3 months from randomisation. Secondary end-points include any TIA or stroke, major bleeding and presence of residual stenosis at 3 months (>50%). All neuroimaging and serious adverse events will be adjudicated blinded to treatment. An initial feasibility phase of 250 subjects will allow us to determine whether *there are sufficient clinical end-points to provide the power to determine a treatment effect and *adequate numbers of patients can be recruited. The feasibility phase will be continued into a fully powered definitive treatment trial. Initial power calculations based on limited natural history data suggest a sample size of approximately 3000. Sample size calculations will be refined once the frequency of outcome events during the feasibility phase is known.

      Pubmed     Full text   Copy Citation     Plaintext  

      Add institutional full text...

    Notes

     
    Knowledge, pearl, summary or comment to share?
    300 characters remaining
    help        
    You can also include formatting, links, images and footnotes in your notes
    • Simple formatting can be added to notes, such as *italics*, _underline_ or **bold**.
    • Superscript can be denoted by <sup>text</sup> and subscript <sub>text</sub>.
    • Numbered or bulleted lists can be created using either numbered lines 1. 2. 3., hyphens - or asterisks *.
    • Links can be included with: [my link to pubmed](http://pubmed.com)
    • Images can be included with: ![alt text](https://bestmedicaljournal.com/study_graph.jpg "Image Title Text")
    • For footnotes use [^1](This is a footnote.) inline.
    • Or use an inline reference [^1] to refer to a longer footnote elseweher in the document [^1]: This is a long footnote..

    hide…