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

Primary Purpose

Ischemic Stroke, TIA

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

rivaroxaban

Aspirin

placebo

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring rivaroxaban, aspirin, new oral anticoagulant, TIA, acute minor ischemic stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Xijing Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

aspirin

Rivaroxaban 5mg

rivaroxaban 10mg

Arm Description

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

Outcomes

Primary Outcome Measures

percentage of patients with new stroke (ischemic or hemorrhage)

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01923818

First Posted

July 19, 2013

Last Updated

August 13, 2013

Sponsor

Xijing Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01923818

Brief Title

Treatment of Rivaroxaban Versus Aspirin for Non-disabling Cerebrovascular Events

Acronym

TRACE

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 Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Unknown status

Study Start Date

September 2013 (undefined)

Primary Completion Date

September 2015 (Anticipated)

Study Completion Date

April 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xijing Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Stroke, TIA

Keywords

rivaroxaban, aspirin, new oral anticoagulant, TIA, acute minor ischemic stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

3700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

aspirin

Arm Type

Active Comparator

Arm Description

Receiving a 100-mg dose of aspirin and placebo rivaroxaban from day 1 to day 30

Arm Title

Rivaroxaban 5mg

Arm Type

Experimental

Arm Description

Receiving a 5-mg dose of rivaroxaban and placebo aspirin from day 1 to day 30

Arm Title

rivaroxaban 10mg

Arm Type

Experimental

Arm Description

Receiving a 10-mg dose of rivaroxaban and placebo aspirin from day 1 to day 30

Intervention Type

Drug

Intervention Name(s)

rivaroxaban

Other Intervention Name(s)

BAY 59-7939, Xarelto

Intervention Description

orally active direct factor Xa inhibitor

Intervention Type

Drug

Intervention Name(s)

Aspirin

Other Intervention Name(s)

Acetylsalicylic acid

Intervention Description

non-steroidal anti-inflammatory drugs

Intervention Type

Drug

Intervention Name(s)

placebo

Primary Outcome Measure Information:

Title

percentage of patients with new stroke (ischemic or hemorrhage)

Time Frame

90 days

Secondary Outcome Measure Information:

Title

Percentage of patients with new clinical vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death)

Time Frame

30 days

Title

mRS score changes (continuous) and dichotomized at percentage with score 0 to 2 versus 3 to 6

Time Frame

30 days and 90 days

Title

Changes in NIHSS scores

Time Frame

90 days

Title

moderate to severe bleeding events

Time Frame

90 days

Title

Total mortality

Time Frame

90 days

Title

Adverse events/severe adverse events reported by the investigators

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xuedong Liu, M.D.

Phone

+86 029 84775055

liuxued@fmmu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gang Zhao, M.D.

Organizational Affiliation

Neurology Department,Xijing Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Xijing Hospital

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710032

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fang Yang, M.D. Ph.D.

Phone

+86 029 84773214

fyangx@fmmu.edu.cn

First Name & Middle Initial & Last Name & Degree

Gang Zhao, M.D.

12. IPD Sharing Statement

Citations:

PubMed Identifier

26458895

Citation

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.

Results Reference

derived

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Treatment of Rivaroxaban Versus Aspirin for Non-disabling Cerebrovascular Events

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