Treatment of Rivaroxaban Versus Aspirin for Non-disabling Cerebrovascular Events

Ischemic Stroke Clinical Trial

— TRACE  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01923818
• Other study ID #: Xijing-TRACE
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: July 19, 2013
• Last updated: August 13, 2013
• Start date: September 2013
• Est. completion date: April 2016

Study information

• Verified date: August 2013
• Source: Xijing Hospital
• Contact: Xuedong Liu, M.D.
• Phone: +86 029 84775055
• Email: liuxued[@]fmmu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeChina: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3700
• Est. completion date: April 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Ischemic Stroke
• TIA

Intervention

Drug:
• rivaroxaban
orally active direct factor Xa inhibitor
• Aspirin
non-steroidal anti-inflammatory drugs
• placebo

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	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