Treatment of Rivaroxaban Versus Aspirin for Non-disabling Cerebrovascular Events

NCT ID: NCT01923818

Last Updated: 2013-08-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 3700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2016-04-30

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.

Conditions

Ischemic Stroke; TIA

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

aspirin

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

Group Type: ACTIVE_COMPARATOR

Aspirin

Intervention Type: DRUG

non-steroidal anti-inflammatory drugs

placebo

Intervention Type: DRUG

Rivaroxaban 5mg

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

Group Type: EXPERIMENTAL

rivaroxaban

Intervention Type: DRUG

orally active direct factor Xa inhibitor

placebo

Intervention Type: DRUG

rivaroxaban 10mg

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

Group Type: EXPERIMENTAL

rivaroxaban

Intervention Type: DRUG

orally active direct factor Xa inhibitor

placebo

Intervention Type: DRUG

Interventions

rivaroxaban

orally active direct factor Xa inhibitor

Intervention Type: DRUG

Aspirin

non-steroidal anti-inflammatory drugs

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Other Intervention Names

BAY 59-7939; Xarelto; Acetylsalicylic acid

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gang Zhao, M.D.

Role: PRINCIPAL_INVESTIGATOR

Neurology Department,Xijing Hospital

Locations

Xijing Hospital

Xi'an, Shaanxi, China

Countries

China

Central Contacts

Xuedong Liu, M.D.

Role: CONTACT

Phone: +86 029 84775055

Email: liuxued@fmmu.edu.cn

Facility Contacts

Fang Yang, M.D. Ph.D.

Role: primary

References

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.

Reference Type: DERIVED

PMID: 26458895 (View on PubMed)

Other Identifiers

Xijing-TRACE

Identifier Type: -

Identifier Source: org_study_id