Treatment of Rivaroxaban Versus Aspirin for Non-disabling Cerebrovascular Events "TRACE"

Not yet recruiting

Phase 2/3 Results N/A

Trial Description

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.

Conditions

Interventions

  • Aspirin Drug
    Other Names: Aspirin at bedtime
    Intervention Desc: non-steroidal anti-inflammatory drugs
    ARM 1: Kind: Experimental
    Label: aspirin
    Description: Receiving a 100-mg dose of aspirin and placebo rivaroxaban from day 1 to day 30
  • Placebo Drug
    ARM 1: Kind: Experimental
    Label: aspirin
    Description: Receiving a 100-mg dose of aspirin and placebo rivaroxaban from day 1 to day 30
    ARM 2: Kind: Experimental
    Label: Rivaroxaban 5mg
    Description: Receiving a 5-mg dose of rivaroxaban and placebo aspirin from day 1 to day 30
    ARM 3: Kind: Experimental
    Label: rivaroxaban 10mg
    Description: Receiving a 10-mg dose of rivaroxaban and placebo aspirin from day 1 to day 30
  • Rivaroxaban Drug
    Intervention Desc: orally active direct factor Xa inhibitor
    ARM 1: Kind: Experimental
    Label: Rivaroxaban 5mg
    Description: Receiving a 5-mg dose of rivaroxaban and placebo aspirin from day 1 to day 30
    ARM 2: Kind: Experimental
    Label: rivaroxaban 10mg
    Description: Receiving a 10-mg dose of rivaroxaban and placebo aspirin from day 1 to day 30

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary percentage of patients with new stroke (ischemic or hemorrhage) 90 days No
Secondary Percentage of patients with new clinical vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death) 30 days Yes
Secondary mRS score changes (continuous) and dichotomized at percentage with score 0 to 2 versus 3 to 6 30 days and 90 days No
Secondary Changes in NIHSS scores 90 days No
Secondary moderate to severe bleeding events 90 days Yes
Secondary Total mortality 90 days Yes
Secondary Adverse events/severe adverse events reported by the investigators 90 days Yes

Sponsors