Treatment of Rivaroxaban Versus Aspirin for Non-disabling Cerebrovascular Events (TRACE)

Tracking Information
First Submitted Date ICMJE	July 19, 2013
First Posted Date ICMJE	August 16, 2013
Last Update Posted Date	August 16, 2013
Study Start Date ICMJE	September 2013
Estimated Primary Completion Date	September 2015 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: August 13, 2013)	percentage of patients with new stroke (ischemic or hemorrhage) [ Time Frame: 90 days ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE; (submitted: August 13, 2013)	Percentage of patients with new clinical vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death) [ Time Frame: 30 days ]; mRS score changes (continuous) and dichotomized at percentage with score 0 to 2 versus 3 to 6 [ Time Frame: 30 days and 90 days ]; Changes in NIHSS scores [ Time Frame: 90 days ]; moderate to severe bleeding events [ Time Frame: 90 days ]; Total mortality [ Time Frame: 90 days ]; Adverse events/severe adverse events reported by the investigators [ Time Frame: 90 days ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Treatment of Rivaroxaban Versus Aspirin for Non-disabling Cerebrovascular Events
Official Title ICMJE	Randomized,Double-blind Trial Comparing the Effects of a Rivaroxaban Regimen During the First 30 Days,Versus Aspirin for the Acute Treatment of TIA or Minor Stroke
Brief Summary	Transient ischemic attack (TIA) or minor ischemic stroke has a high risk of early recurrent stroke. As the golden standard, aspirin effect modestly on acute ischemic stroke, and slightly increase the risk of intracerebral hemorrhage. Recently, rivaroxaban, a new oral anticoagulant, is proved to be as effective as traditional anticoagulants, while carrying significantly less risk of intracranial hemorrhage. The TRACE trial is a randomized, double-blind, multicenter, controlled clinical trial in China. The investigators will assess the hypothesis that a 30-days rivaroxaban regimen is superior to aspirin alone for the treatment of high-risk patients with acute nondisabling cerebrovascular event.
Detailed Description	The TRACE study is a randomized, double-blind clinical trial with a target enrollment of 3,700 Chinese patients. Two subtypes of patients will be enrolled: I, acute disabling ischemic stroke (<24 hours of symptoms onset); II, acute TIA (<24 hours of symptoms onset). Patients will be randomized into 3 groups: Receiving a 100-mg dose of aspirin and placebo rivaroxaban from day 1 to day 30; Receiving a 5-mg dose of rivaroxaban and placebo aspirin from day 1 to day 30; Receiving a 10-mg dose of rivaroxaban and placebo aspirin from day 1 to day 30 The primary efficacy end point is percentage of patients with new stroke (ischemic or hemorrhage) at 90 days.
Study Type ICMJE	Interventional
Study Phase	Phase 2; Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
Condition ICMJE	Ischemic Stroke; TIA
Intervention ICMJE	Drug: rivaroxaban orally active direct factor Xa inhibitor Other Names: BAY 59-7939 Xarelto; Drug: Aspirin non-steroidal anti-inflammatory drugs Other Name: Acetylsalicylic acid; Drug: placebo
Study Arms	Active Comparator: aspirin Receiving a 100-mg dose of aspirin and placebo rivaroxaban from day 1 to day 30 Interventions: Drug: Aspirin Drug: placebo; Experimental: Rivaroxaban 5mg Receiving a 5-mg dose of rivaroxaban and placebo aspirin from day 1 to day 30 Interventions: Drug: rivaroxaban Drug: placebo; Experimental: rivaroxaban 10mg Receiving a 10-mg dose of rivaroxaban and placebo aspirin from day 1 to day 30 Interventions: Drug: rivaroxaban Drug: placebo
Publications *	Yang F, Jiang W, Bai Y, Han J, Liu X, Zhang G, Zhao G. Treatment of Rivaroxaban versus Aspirin for Non-disabling Cerebrovascular Events (TRACE): study protocol for a randomized controlled trial. BMC Neurol. 2015 Oct 12;15:195. doi: 10.1186/s12883-015-0453-7.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: August 13, 2013)	3700
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	April 2016
Estimated Primary Completion Date	September 2015 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Adult subjects (male or female ≥18 years old); Acute nondisabling ischemic stroke (NIHSS ≤3 at the time of randomization) that can be treated with study drug within 24 hours of symptoms onset. Symptom onset is defined by the "last see normal" principle; TIA (neurologic deficit attributed to focal brain ischemia, with resolution of the deficit within 24 hours of symptom onset), that can be treated with investigational medication within 24 hours of symptoms onset. Symptom onset is defined by the "last see normal" principle; Informed consent signed Exclusion Criteria: Diagnosis of hemorrhage or other pathology, such as vascular malformation, tumor, abscess or other major nonischemic brain disease, on baseline head CT or MRI scan; mRS score >2 at randomization (premorbid historical assessment); NIHSS ≥4 at randomization; Clear indication for anticoagulation (atrial fibrillation, mechanical cardiac valves, deep venous thrombosis, pulmonary embolism or known hypercoagulable state); Contraindication to investigational medications; Thrombolysis for ischemic stroke within preceding 7 days; History of intracranial hemorrhage; Current treatment (last dose given within 10 days before randomization) with heparin therapy or oral anticoagulation; Gastrointestinal bleed or major surgery within 3 months; Planned or likely revascularization (any angioplasty or vascular surgery) within the next 3 months; TIA or minor stroke induced by angiography or surgery; Severe noncardiovascular comorbidity with life expectancy <3 months; Women of childbearing age not practicing reliable contraception who do not have a documented negative pregnancy test result; Severe renal failure, defined as Glomerular Filtration Rate (GFR) <30 ml/min Severe hepatic insufficiency (Child-Pugh score B to C)
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	China
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01923818
Other Study ID Numbers ICMJE	Xijing-TRACE
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Xijing Hospital
Study Sponsor ICMJE	Xijing Hospital
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Gang Zhao, M.D. Neurology Department,Xijing Hospital
PRS Account	Xijing Hospital
Verification Date	August 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP