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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

Page last updated: August 23, 2015

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