Early Rivaroxaban for Acute Ischemic Stroke or TIA Patients With Atrial Fibrillation

NCT03749057 | Completed Phase 4 DMC

• 1 other identifier: k （2018）39
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Anticoagulant treatment for non-valvular atrial fibrillation (AF) associated with cerebral infarction/ TIA is one of the recognized treatment of stroke prevention. The ACC/AHA and national guidelines for the management of anticoagulation recommend that most of AF patients with cerebral infarction or TIA should be administrated anticoagulant therapy within 14 days of symptom onset, while European guidelines recommend that the timing of the initiation of non-vitamin K antagonist oral anticoagulants (NOACs) for AF patients with cerebral infarction or TIA is association with stroke severity in light of the "1-3-6-12" principle. However, there are still many problems about the use of NOACs in ischemic stroke with AF. for example, it is unclear what time to begin NOACs as to difference in stroke severity, ages, comorbidity with hypertension, diabetes, heart failure, liver and kidney dysfunction and bleeding risks. Thus, the timing of the initiation of NOACs is yet to be further studied. Current urgent need is to develop a guideline-based specific regimen in which the benefit-risk factors are further balanced with a combination of NHISS, CHA2DS2-VASC and HAS-BLED score. Rivaroxaban, a direct coagulation factor Ⅹa inhibitor, blocks the formation of the clot. ROCKET-AF study has shown that the efficacy of rivaroxaban is not inferior to that of warfarin in AF patients on stroke prevention, and rivaroxaban has a significantly decreased bleeding risk compared with warfarin. Recent study indicates that early administration with rivaroxaban for AF patients within 14 days of onset does not significantly increase hemorrhagic transformation. However, the relevant clinical data of the efficacy and safety of early initiation of rivaroxaban in AF patients with cerebral infarction or TIA are lacking in China. Therefore, the investigators conduct a multicenter cohort study to investigate the safety of early rivaroxaban in the AF patient with cerebral infarction or TIA within 12 days of onset.

Conditions

Cerebral Infarction; TIA

Keywords

rivaroxaban

Outcome Measures

Primary Outcomes (1)

• incidence of intracranial hemorrhage

  7 days

Secondary Outcomes (4)

• incidence of early neurological deterioration

  7 days

• recurrence of stroke or other vascular events

  90 days

• bleeding event

  90 days

• Serious adverse events

  90 days

Study Arms (1)

rivaroxaban

OTHER

15-20 mg rivaroxaban daily

Drug: Rivaroxaban

Interventions

Rivaroxaban DRUG

Rivaroxaban 15-20 mg daily

rivaroxaban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years
• Acute cerebral infarction caused by non-valvular atrial fibrillation
• NIHSS score ≤ 15
• Within 12 days of onset
• first stroke onset or past stroke without obvious neurological deficit (mRS score≤1)
• Signed informed consent

You may not qualify if:

• Hemorrhagic stroke or mixed stroke
• Patients with valvular atrial fibrillation or non-cardiogenic cerebral infarction
• Patients with severe infection or serious diseases
• Gastrointestinal bleeding or major operation within 3 months
• Planed cerebrovascular reconstruction or cardiac surgery within 3 months
• Planed major surgery within 3 months
• Participating in other clinical trials within 3 months
• Unsuitable for this trial assessed by research

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

General Hospital of ShenYang Military Region

Shenyang, China

Location

MeSH Terms

Conditions

Cerebral Infarction

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Huisheng Chen, Doctor

  Neurology Department

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Chairman

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: November 21, 2018
• Study Start: November 20, 2018
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

CN (1)