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
  Purpose

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.


Condition Intervention Phase
Ischemic Stroke
TIA
Drug: rivaroxaban
Drug: Aspirin
Drug: placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • percentage of patients with new stroke (ischemic or hemorrhage) [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 3700
Study Start Date: September 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: aspirin
Receiving a 100-mg dose of aspirin and placebo rivaroxaban from day 1 to day 30
Drug: Aspirin
non-steroidal anti-inflammatory drugs
Other Name: Acetylsalicylic acid
Drug: placebo
Experimental: Rivaroxaban 5mg
Receiving a 5-mg dose of rivaroxaban and placebo aspirin from day 1 to day 30
Drug: rivaroxaban
orally active direct factor Xa inhibitor
Other Names:
  • BAY 59-7939
  • Xarelto
Drug: placebo
Experimental: rivaroxaban 10mg
Receiving a 10-mg dose of rivaroxaban and placebo aspirin from day 1 to day 30
Drug: rivaroxaban
orally active direct factor Xa inhibitor
Other Names:
  • BAY 59-7939
  • Xarelto
Drug: placebo

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01923818

Contacts
Contact: Xuedong Liu, M.D. +86 029 84775055 liuxued@fmmu.edu.cn

Locations
China, Shaanxi
Xijing Hospital Not yet recruiting
Xi'an, Shaanxi, China, 710032
Contact: Fang Yang, M.D. Ph.D.    +86 029 84773214    fyangx@fmmu.edu.cn   
Principal Investigator: Gang Zhao, M.D.         
Sponsors and Collaborators
Xijing Hospital
Investigators
Principal Investigator: Gang Zhao, M.D. Neurology Department,Xijing Hospital
  More Information

No publications provided

Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT01923818     History of Changes
Other Study ID Numbers: Xijing-TRACE
Study First Received: July 19, 2013
Last Updated: August 13, 2013
Health Authority: China: Ethics Committee
China: Ministry of Health

Keywords provided by Xijing Hospital:
rivaroxaban
aspirin
new oral anticoagulant
TIA
acute minor ischemic stroke

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors

ClinicalTrials.gov processed this record on July 22, 2014