Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2026-03-06 @ 11:49 AM
Study NCT ID:
NCT01923818
Status:
UNKNOWN
Last Update Posted:
2013-08-16
First Post:
2013-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Rivaroxaban Versus Aspirin for Non-disabling Cerebrovascular Events
Sponsor:
Xijing Hospital
Organization:
Study Overview
Official Title:
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
Status:
UNKNOWN
Status Verified Date:
2013-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRACE
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: