CADISS
Trial question
What is the effect of antiplatelet therapy in patients with extracranial carotid and vertebral artery dissection?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
30.0% female
70.0% male
N = 250
250 patients (76 female, 174 male).
Inclusion criteria: patients with extracranial carotid and vertebral dissection with onset of symptoms within the past 7 days.
Key exclusion criteria: intracranial cerebral artery dissection; contraindications to either antiplatelet or anticoagulation drugs, including active peptic ulceration or bleeding peptic ulcer within 1 year; use of antiplatelet or anticoagulants drugs for other reasons (eg, prosthetic heart valves); and pregnancy.
Interventions
N=126 antiplatelet treatment (aspirin, dipyridamole, or clopidogrel alone or in combination, aiming for an INR of 2-3).
N=124 anticoagulant treatment (heparin (either UFH or a therapeutic dose of low-molecular-weight heparin) followed by warfarin, aiming for an INR of 2-3).
Primary outcome
Ipsilateral stroke or death at 3 months, in intention-to-treat population
2%
1%
2.0 %
1.5 %
1.0 %
0.5 %
0.0 %
Antiplatelet
treatment
Anticoagulant
treatment
No significant
difference ↔
No significant difference in ipsilateral stroke or death at 3 months, in the intention-to-treat population (2% vs. 1%; OR 0.335, 95% CI 0.01 to 4.23).
Secondary outcomes
No significant difference in stroke, major bleeding, or death (3% vs. 2%; OR 0.673, 95% CI 0.06 to 5.98).
Safety outcomes
No significant differences in adverse events, including major bleeding (0% vs. 1%).
Conclusion
In patients with extracranial carotid and vertebral dissection with onset of symptoms within the past 7 days, antiplatelet treatment was not superior to anticoagulant treatment with respect to ipsilateral stroke or death at 3 months, in the intention-to-treat population.
Reference
CADISS trial investigators, Markus HS, Hayter E et al. Antiplatelet treatment compared with anticoagulation treatment for cervical artery dissection (CADISS): a randomised trial. Lancet Neurol. 2015 Apr;14(4):361-7.
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