ARCADIA
Trial question
What is the role of apixaban in patients with cryptogenic stroke and evidence of atrial cardiopathy without AF?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
54.0% female
46.0% male
N = 1015
1015 patients (551 female, 464 male)
Inclusion criteria: patients with cryptogenic stroke and evidence of atrial cardiopathy without AF, within 180 days of stroke
Key exclusion criteria: major-risk cardioembolic source including any history of AF or LVEF < 30%; definite indication or contraindication to antiplatelet or anticoagulant therapy; history of spontaneous ICH; CKD; clinically significant bleeding diathesis
Interventions
N=507 apixaban (an oral dose of 5 mg or 2.5 mg BID plus aspirin placebo)
N=508 aspirin (an oral dose of 81 mg once daily plus apixaban placebo)
Primary outcome
Recurrent stroke
4.4
4.4
4.4 %
3.3 %
2.2 %
1.1 %
0.0 %
Apixaban
Aspirin
No significant difference ↔
No significant difference in recurrent stroke (4.4% vs. 4.4%; HR 1, 95% CI 0.64 to 1.55)
Secondary outcomes
No significant difference in recurrent ischemic stroke or systemic embolism (4.1% vs. 4.4%; HR 0.92, 95% CI 0.59 to 1.44)
No significant difference in recurrent stroke or death from any cause (7.3% vs. 6.8%; HR 1.08, 95% CI 0.76 to 1.52)
Safety outcomes
No significant differences in major hemorrhage, death from all causes.
Conclusion
In patients with cryptogenic stroke and evidence of atrial cardiopathy without AF, within 180 days of stroke, apixaban was not superior to aspirin with respect to recurrent stroke.
Reference
Hooman Kamel, W T Longstreth Jr, David L Tirschwell et al. Apixaban to Prevent Recurrence After Cryptogenic Stroke in Patients With Atrial Cardiopathy: The ARCADIA Randomized Clinical Trial. JAMA. 2024 Feb 7:e2327188.
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