Treatment of Rivaroxaban Versus Aspirin for Non-disabling Cerebrovascular Events
Information source: Xijing Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ischemic Stroke; TIA
Intervention: rivaroxaban (Drug); Aspirin (Drug); placebo (Drug)
Phase: Phase 2/Phase 3
Status: Not yet recruiting
Sponsored by: Xijing Hospital Official(s) and/or principal investigator(s): Gang Zhao, M.D., Principal Investigator, Affiliation: Neurology Department,Xijing Hospital
Overall contact: Xuedong Liu, M.D., Phone: +86 029 84775055, Email: liuxued@fmmu.edu.cn
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: percentage of patients with new stroke (ischemic or hemorrhage)
Secondary outcome: Percentage of patients with new clinical vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death)mRS score changes (continuous) and dichotomized at percentage with score 0 to 2 versus 3 to 6 Changes in NIHSS scores moderate to severe bleeding events Total mortality Adverse events/severe adverse events reported by the investigators
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Xuedong Liu, M.D., Phone: +86 029 84775055, Email: liuxued@fmmu.edu.cn
Xijing Hospital, Xi'an, Shaanxi 710032, China; Not yet recruiting Fang Yang, M.D. Ph.D., Phone: +86 029 84773214, Email: fyangx@fmmu.edu.cn Gang Zhao, M.D., Principal Investigator
Additional Information
Starting date: September 2013
Last updated: August 13, 2013
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