Clinical Trial: To Determine the Feasibility of a Clinical Trial Comparing Anticoagulants Versus Antiplatelets in the Acute Treatment of Patients With Cervical Artery Dissection
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Cervical Artery Dissection in Stroke Study
Brief Summary: This is a feasibility study to determine if a sufficient number of patients can be recruited throughout the United Kingdom and whether sufficient endpoints can be generated for a full scale therapeutic trial of anticoagulants versus antiplatelets in acute cervical artery dissection treatment.
Detailed Summary:
ST. GEORGE'S HEADED NOTEPAPER
CADISS FEASIBILITY STUDY (Cervical Artery Dissection in Stroke Study) PROTOCOL
Aim:
To determine the feasibility of a clinical trial comparing antiplatelet therapy with anticoagulation in the acute treatment of patients with cervical artery dissection. Specifically to address whether:
- There are sufficient clinical endpoints to provide the power to determine treatment effect;
- Adequate numbers of patients can be recruited.
Dissection of the carotid and vertebral arteries is a major cause of stroke in persons < 50 years of age, mainly due to embolism from clot sealing the tear. At present physicians treat these patients with anticoagulants or antiplatelet drugs to prevent further stroke, but neither therapy is evidence-based. Anticoagulants may be powerful anti-embolic agents but are also more dangerous than aspirin, and potentially could encourage further dissection. Most published studies are flawed by retrospective data, with no reference to the number of patients in the original study cohort and do not include the critical principles of randomisation and 'blinding'.
Proposal of present 'feasibility'study:
The only prospective data available (1) suggest that anticoagulants are more effective than antiplatelet agents in reducing further TIA and stroke after dissection, but the numbers were small and lack reliable statistical confirmation. This study was not a randomised controlled trial and therefore may be open to bias in selection of treatment. As well, it found that most
Sponsor: St George's, University of London
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: St George's, University of London
Dates:
Date Received: October 11, 2005
Date Started: November 2005
Date Completion:
Last Updated: May 19, 2015
Last Verified: September 2005
