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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2013 by Xijing Hospital
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01923818
First received: July 19, 2013
Last updated: August 13, 2013
Last verified: August 2013

July 19, 2013
August 13, 2013
September 2013
September 2015   (final data collection date for primary outcome measure)
percentage of patients with new stroke (ischemic or hemorrhage) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01923818 on ClinicalTrials.gov Archive Site
  • Percentage of patients with new clinical vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • mRS score changes (continuous) and dichotomized at percentage with score 0 to 2 versus 3 to 6 [ Time Frame: 30 days and 90 days ] [ Designated as safety issue: No ]
  • Changes in NIHSS scores [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • moderate to severe bleeding events [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • Total mortality [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • Adverse events/severe adverse events reported by the investigators [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Treatment of Rivaroxaban Versus Aspirin for Non-disabling Cerebrovascular Events
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

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Ischemic Stroke
  • TIA
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
3700
April 2016
September 2015   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Xuedong Liu, M.D. +86 029 84775055 liuxued@fmmu.edu.cn
China
 
NCT01923818
Xijing-TRACE
Yes
Xijing Hospital
Xijing Hospital
Not Provided
Principal Investigator: Gang Zhao, M.D. Neurology Department,Xijing Hospital
Xijing Hospital
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP