Treatment of Rivaroxaban Versus Aspirin for Non-disabling Cerebrovascular Events

NCT01923818 | Unknown Phase 2 DMC

• 1 other identifier: Xijing-TRACE
• Study Type: interventional
• Target: 3,700
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke; TIA

Keywords

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

Outcome Measures

Primary Outcomes (1)

• percentage of patients with new stroke (ischemic or hemorrhage)

  90 days

Secondary Outcomes (6)

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

  30 days

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

  30 days and 90 days

• Changes in NIHSS scores

  90 days

• moderate to severe bleeding events

  90 days

• Total mortality

  90 days

Study Arms (3)

aspirin

ACTIVE COMPARATOR

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

Drug: Aspirin; Drug: placebo

Rivaroxaban 5mg

EXPERIMENTAL

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

Drug: rivaroxaban; Drug: placebo

rivaroxaban 10mg

EXPERIMENTAL

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

Drug: rivaroxaban; Drug: placebo

Interventions

rivaroxaban DRUG

orally active direct factor Xa inhibitor

Also known as: BAY 59-7939, Xarelto

Rivaroxaban 5mg; rivaroxaban 10mg

Aspirin DRUG

non-steroidal anti-inflammatory drugs

Also known as: Acetylsalicylic acid

aspirin

placebo DRUG

Rivaroxaban 5mg; aspirin; rivaroxaban 10mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

Related Publications (1)

• 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.

  PMID: 26458895 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Rivaroxaban; Aspirin

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Gang Zhao, M.D.

  Neurology Department,Xijing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuedong Liu, M.D.

CONTACT

+86 029 84775055; liuxued@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2013
• First Posted: August 16, 2013
• Study Start: September 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: April 1, 2016
• Last Updated: August 16, 2013

Record last verified: 2013-08

Locations

CN (1)