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

NCT ID: NCT03749057

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-20
• Study Completion Date: 2025-03-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

rivaroxaban

15-20 mg rivaroxaban daily

Group Type: OTHER

Rivaroxaban

Intervention Type: DRUG

Rivaroxaban 15-20 mg daily

Interventions

Rivaroxaban

Rivaroxaban 15-20 mg daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Over 18 years

2. Acute cerebral infarction caused by non-valvular atrial fibrillation

3. NIHSS score ≤ 15

4. Within 12 days of onset

5. first stroke onset or past stroke without obvious neurological deficit (mRS score≤1)

6. Signed informed consent

Exclusion Criteria

1. Hemorrhagic stroke or mixed stroke

2. Patients with valvular atrial fibrillation or non-cardiogenic cerebral infarction

3. Patients with severe infection or serious diseases

4. Gastrointestinal bleeding or major operation within 3 months

5. Planed cerebrovascular reconstruction or cardiac surgery within 3 months

6. Planed major surgery within 3 months

7. Participating in other clinical trials within 3 months

8. Unsuitable for this trial assessed by research

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

General Hospital of Shenyang Military Region

OTHER

Sponsor Role: lead

Responsible Party

Hui-Sheng Chen

Department Chairman

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Huisheng Chen, Doctor

Role: STUDY_CHAIR

Neurology Department

Locations

General Hospital of ShenYang Military Region

Shenyang, , China

Countries

China

Other Identifiers

k （2018）39

Identifier Type: -

Identifier Source: org_study_id