Abstract | BACKGROUND: METHODS AND DESIGN: The Treatment of Rivaroxaban versus Aspirin in Non-disabling Cerebrovascular Events (TRACE) study is a randomized, double-blind clinical trial with a target enrollment of 4400 patients. A 14-days regimen of rivaroxaban 10 mg daily or a 14-days regimen of aspirin 100 mg daily will be administrated to randomized participants with acute TIA or minor stroke, defined as National Institute of Health Stroke Scale scores ≤ 3. The primary efficacy end point is percentage of patients with any stroke (ischemic or hemorrhage) at 14 days. Study visits will be performed at the day of randomization, day 14 and day 90. DISCUSSION: Even though the new oral anticoagulants seem to be both safe and effective, few clinical trials have been carried out to test their effect on non-disabling cerebrovascular events. Treatment with rivaroxaban may prevent more cerebrovascular events with an acceptable risk profile after TIA or minor stroke, compared with aspirin, thus helping to improve the outcome of the disease. TRIAL REGISTRATION: No. NCT01923818.
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Authors | Fang Yang, Wenrui Jiang, Ya Bai, Junliang Han, Xuedong Liu, Guangyun Zhang, Gang Zhao |
Journal | BMC neurology
(BMC Neurol)
Vol. 15
Pg. 195
(Oct 12 2015)
ISSN: 1471-2377 [Electronic] England |
PMID | 26458895
(Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Factor Xa Inhibitors
- Platelet Aggregation Inhibitors
- Rivaroxaban
- Aspirin
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Topics |
- Adult
- Aspirin
(administration & dosage, pharmacology)
- Clinical Protocols
- Factor Xa Inhibitors
(administration & dosage, pharmacology)
- Female
- Humans
- Ischemic Attack, Transient
(prevention & control, therapy)
- Male
- Outcome Assessment, Health Care
- Platelet Aggregation Inhibitors
(administration & dosage, pharmacology)
- Recurrence
- Rivaroxaban
(administration & dosage, pharmacology)
- Stroke
(prevention & control, therapy)
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