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
Overview
- Phase
- Phase 2
- Intervention
- Aspirin
- Conditions
- Ischemic Stroke
- Sponsor
- Xijing Hospital
- Enrollment
- 3700
- Locations
- 1
- Primary Endpoint
- percentage of patients with new stroke (ischemic or hemorrhage)
- Last Updated
- 12 years ago
Overview
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.
Investigators
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
Arms & Interventions
aspirin
Receiving a 100-mg dose of aspirin and placebo rivaroxaban from day 1 to day 30
Intervention: Aspirin
aspirin
Receiving a 100-mg dose of aspirin and placebo rivaroxaban from day 1 to day 30
Intervention: placebo
Rivaroxaban 5mg
Receiving a 5-mg dose of rivaroxaban and placebo aspirin from day 1 to day 30
Intervention: rivaroxaban
Rivaroxaban 5mg
Receiving a 5-mg dose of rivaroxaban and placebo aspirin from day 1 to day 30
Intervention: placebo
rivaroxaban 10mg
Receiving a 10-mg dose of rivaroxaban and placebo aspirin from day 1 to day 30
Intervention: rivaroxaban
rivaroxaban 10mg
Receiving a 10-mg dose of rivaroxaban and placebo aspirin from day 1 to day 30
Intervention: placebo
Outcomes
Primary Outcomes
percentage of patients with new stroke (ischemic or hemorrhage)
Time Frame: 90 days
Secondary Outcomes
- 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)
- Adverse events/severe adverse events reported by the investigators(90 days)