title: Treatment of Rivaroxaban versus Aspirin for Non-disabling Cerebrovascular Events (TRACE): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Transient ischemic attack (TIA) or minor ischemic stroke represents the largest group of cerebrovascular disease, and those patients have a high risk of early recurrent stroke. Over decades, anticoagulation therapy has been used prudently in them for likely increasing the risk of intra-/extra-cranial hemorrhagic complications. However, recently rivaroxaban, a new oral anticoagulant, is proved to be as effective as traditional anticoagulants, while carrying significantly less risk of intracranial hemorrhage. Therefore, we assumed that patients may benefit from rivaroxaban if treated soon after TIA or minor stroke, and designed this adequately powered randomized study, TRACE.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  No. NCT01923818.
authors.affiliation: Department of Neurology, Xijing Hospital, No. 15 West Changle Road, Xi'an, 710032, China. fyangx@fmmu.edu.cn.
authors.forename: Fang
authors.initials: F
authors.lastname: Yang
authors.affiliation: Emergency Department, Xijing Hospital, No. 15 West Changle Road, Xi'an, 710032, China. jiangwr@fmmu.edu.cn.
authors.forename: Wenrui
authors.initials: W
authors.lastname: Jiang
authors.affiliation: Department of Neurology, Xijing Hospital, No. 15 West Changle Road, Xi'an, 710032, China. xiabing616@163.com.
authors.forename: Ya
authors.initials: Y
authors.lastname: Bai
authors.affiliation: Department of Neurology, Xijing Hospital, No. 15 West Changle Road, Xi'an, 710032, China. hanjunliang@gmail.com.
authors.forename: Junliang
authors.initials: J
authors.lastname: Han
authors.affiliation: Department of Neurology, Xijing Hospital, No. 15 West Changle Road, Xi'an, 710032, China. liuxued@fmmu.edu.cn.
authors.forename: Xuedong
authors.initials: X
authors.lastname: Liu
authors.affiliation: Department of Neurology, Xijing Hospital, No. 15 West Changle Road, Xi'an, 710032, China. zhgyun@fmmu.edu.cn.
authors.forename: Guangyun
authors.initials: G
authors.lastname: Zhang
authors.affiliation: Department of Neurology, Xijing Hospital, No. 15 West Changle Road, Xi'an, 710032, China. zhaogang@fmmu.edu.cn.
authors.forename: Gang
authors.initials: G
authors.lastname: Zhao
mesh_terms: D000328:Adult; D001241:Aspirin / Q000008:administration & dosage / Q000494:pharmacology*; D002985:Clinical Protocols; D065427:Factor Xa Inhibitors / Q000008:administration & dosage / Q000494:pharmacology*; D005260:Female; D006801:Humans; D002546:Ischemic Attack, Transient / Q000517:prevention & control / Q000628:therapy*; D008297:Male; D017063:Outcome Assessment, Health Care; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage / Q000494:pharmacology*; D012008:Recurrence; D000069552:Rivaroxaban / Q000008:administration & dosage / Q000494:pharmacology*; D020521:Stroke / Q000517:prevention & control / Q000628:therapy*
chemical_list: D065427:Factor Xa Inhibitors; D010975:Platelet Aggregation Inhibitors; D000069552:Rivaroxaban; D001241:Aspirin