- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01923818
Treatment of Rivaroxaban Versus Aspirin for Non-disabling Cerebrovascular Events (TRACE)
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710032
- Xijing Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: aspirin
Receiving a 100-mg dose of aspirin and placebo rivaroxaban from day 1 to day 30
|
non-steroidal anti-inflammatory drugs
Other Names:
|
Experimental: Rivaroxaban 5mg
Receiving a 5-mg dose of rivaroxaban and placebo aspirin from day 1 to day 30
|
orally active direct factor Xa inhibitor
Other Names:
|
Experimental: rivaroxaban 10mg
Receiving a 10-mg dose of rivaroxaban and placebo aspirin from day 1 to day 30
|
orally active direct factor Xa inhibitor
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
percentage of patients with new stroke (ischemic or hemorrhage)
Time Frame: 90 days
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total mortality
Time Frame: 90 days
|
90 days
|
Percentage of patients with new clinical vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death)
Time Frame: 30 days
|
30 days
|
mRS score changes (continuous) and dichotomized at percentage with score 0 to 2 versus 3 to 6
Time Frame: 30 days and 90 days
|
30 days and 90 days
|
Changes in NIHSS scores
Time Frame: 90 days
|
90 days
|
moderate to severe bleeding events
Time Frame: 90 days
|
90 days
|
Adverse events/severe adverse events reported by the investigators
Time Frame: 90 days
|
90 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gang Zhao, M.D., Neurology Department,Xijing Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Stroke
- Ischemic Stroke
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Protease Inhibitors
- Factor Xa Inhibitors
- Antithrombins
- Serine Proteinase Inhibitors
- Anticoagulants
- Aspirin
- Rivaroxaban
Other Study ID Numbers
- Xijing-TRACE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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