Treatment of Rivaroxaban Versus Aspirin for Non-disabling Cerebrovascular Events (TRACE)
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ClinicalTrials.gov Identifier: NCT01923818 |
Recruitment Status
: Unknown
Verified August 2013 by Xijing Hospital.
Recruitment status was: Not yet recruiting
First Posted
: August 16, 2013
Last Update Posted
: August 16, 2013
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Tracking Information | ||||
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First Submitted Date ICMJE | July 19, 2013 | |||
First Posted Date ICMJE | August 16, 2013 | |||
Last Update Posted Date | August 16, 2013 | |||
Study Start Date ICMJE | September 2013 | |||
Estimated Primary Completion Date | September 2015 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
percentage of patients with new stroke (ischemic or hemorrhage) [ Time Frame: 90 days ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Treatment of Rivaroxaban Versus Aspirin for Non-disabling Cerebrovascular Events | |||
Official Title ICMJE | 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 | |||
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. |
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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:
The primary efficacy end point is percentage of patients with new stroke (ischemic or hemorrhage) at 90 days. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 Phase 3 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * | 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
3700 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date | April 2016 | |||
Estimated Primary Completion Date | September 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | China | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01923818 | |||
Other Study ID Numbers ICMJE | Xijing-TRACE | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Xijing Hospital | |||
Study Sponsor ICMJE | Xijing Hospital | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Xijing Hospital | |||
Verification Date | August 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |