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

A

Air Force Military Medical University of People's Liberation Army

Status and phase

Unknown
Phase 3
Phase 2

Conditions

TIA
Ischemic Stroke

Treatments

Drug: Aspirin
Drug: rivaroxaban
Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01923818
Xijing-TRACE

Details and patient eligibility

About

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.

Full 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.

Enrollment

3,700 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

3,700 participants in 3 patient groups

aspirin
Active Comparator group
Description:
Receiving a 100-mg dose of aspirin and placebo rivaroxaban from day 1 to day 30
Treatment:
Drug: Aspirin
Drug: placebo
Rivaroxaban 5mg
Experimental group
Description:
Receiving a 5-mg dose of rivaroxaban and placebo aspirin from day 1 to day 30
Treatment:
Drug: rivaroxaban
Drug: placebo
rivaroxaban 10mg
Experimental group
Description:
Receiving a 10-mg dose of rivaroxaban and placebo aspirin from day 1 to day 30
Treatment:
Drug: rivaroxaban
Drug: placebo

Trial contacts and locations

1

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Central trial contact

Xuedong Liu, M.D.

Data sourced from clinicaltrials.gov

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