Ischemic Stroke, TIA
Conditions
Keywords
rivaroxaban, aspirin, new oral anticoagulant, TIA, acute minor ischemic stroke
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.
Interventions
DRUGrivaroxaban
orally active direct factor Xa inhibitor
DRUGAspirin
non-steroidal anti-inflammatory drugs
DRUGplacebo
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| percentage of patients with new stroke (ischemic or hemorrhage) | 90 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Percentage of patients with new clinical vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death) | 30 days |
| Total mortality | 90 days |
| Adverse events/severe adverse events reported by the investigators | 90 days |
| moderate to severe bleeding events | 90 days |
Countries
China
Contacts
Primary ContactXuedong Liu, M.D.
Outcome results
None listed