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

Cerebral Infarction Clinical Trial

— ERSAF  

Official title:

Early Rivaroxaban for Acute Ischemic Stroke or TIA Patients With Atrial Fibrillation: a Prospective, Multicenter, Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03749057
• Other study ID #: k (2018)39
• Status: Recruiting
• Phase: Phase 4
• Start date: November 20, 2018
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2023
• Source: General Hospital of Shenyang Military Region
• Contact: Xinhong Wang, Doctor
• Phone: 15309885658
• Email: 450341972[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cerebral Infarction
• Infarction
• Ischemic Stroke
• TIA

Intervention

Drug:
• Rivaroxaban
Rivaroxaban 15-20 mg daily

Locations

Country	Name	City	State
China	General Hospital of ShenYang Military Region	Shenyang

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Shenyang Military Region

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of intracranial hemorrhage		7 days
Secondary	incidence of early neurological deterioration	2 or more increase in NIHSS	7 days
Secondary	recurrence of stroke or other vascular events		90 days
Secondary	bleeding event	Any bleeding event except intracranial hemorrhage	90 days
Secondary	Serious adverse events		90 days