Abstract | RATIONALE: AIMS: DESIGN: This is a randomized, open-label, blinded endpoint evaluation trial. Inclusion criteria are (1) nonvalvular AF, (2) presumed cardioembolic stroke or transient ischemic attack (TIA) confirmed by MRI within five-days from onset, and (3) mild to moderate stroke severity. We will randomize 196 patients to either rivaroxaban (10 mg once daily for five-days followed by 15 mg or 20 mg once daily) or dose-adjusted warfarin (coadministration of aspirin 100 mg per day until achieving international normalized ratio of 1·7). The study is registered in ClinicalTrials.gov (NCT02042534). STUDY OUTCOMES: The primary endpoint is the composite of recurrent ischemic lesion and intracranial bleeding on MRI at four-weeks. Secondary endpoints are recurrent ischemic lesions, intracranial bleeding, major bleeding, major vascular events, four-week modified Rankin Scale score, and duration of hospitalization after randomization. DISCUSSION: The results of this proof-of-concept trial will guide go/no-go decision to a large phase 3 confirmatory trial.
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Authors | Keun-Sik Hong, Yun Jung Choi, Sun U Kwon, Triple AXEL Investigators |
Journal | International journal of stroke : official journal of the International Stroke Society
(Int J Stroke)
Vol. 10
Issue 1
Pg. 128-33
(Jan 2015)
ISSN: 1747-4949 [Electronic] United States |
PMID | 25346499
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © 2014 The Authors. International Journal of Stroke published by John Wiley & Sons Ltd on behalf of World Stroke Organization. |
Chemical References |
- Factor Xa Inhibitors
- Morpholines
- Thiophenes
- Rivaroxaban
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Topics |
- Adult
- Atrial Fibrillation
(complications)
- Factor Xa Inhibitors
(therapeutic use)
- Female
- Humans
- Male
- Morpholines
(therapeutic use)
- Research Design
- Rivaroxaban
- Stroke
(complications, drug therapy)
- Thiophenes
(therapeutic use)
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