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

• Sponsor: General Hospital of Shenyang Military Region (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03749057
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 49.3
• Patients Per Site Per Month: 8.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Infarction; TIA	Drug: Rivaroxaban	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Early Rivaroxaban for Acute Ischemic Stroke or TIA Patients With Atrial Fibrillation: a Prospective, Multicenter, Cohort Study
• Actual Study Start Date: Nov 20, 2018
• Anticipated Primary Completion Date: Dec 30, 2022
• Anticipated Study Completion Date: Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: rivaroxaban 15-20 mg rivaroxaban daily	Drug: Rivaroxaban; Rivaroxaban 15-20 mg daily

Outcome Measures

Primary Outcome Measures

1. incidence of intracranial hemorrhage [7 days]

Secondary Outcome Measures

1. incidence of early neurological deterioration [7 days]

   2 or more increase in NIHSS

2. recurrence of stroke or other vascular events [90 days]

3. bleeding event [90 days]

   Any bleeding event except intracranial hemorrhage

4. Serious adverse events [90 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	General Hospital of ShenYang Military Region	Shenyang		China

Sponsors and Collaborators

• General Hospital of Shenyang Military Region

Investigators

• Study Chair: Huisheng Chen, Doctor, Neurology Department

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hui-Sheng Chen, Department Chairman, General Hospital of Shenyang Military Region
• ClinicalTrials.gov Identifier: NCT03749057
• Other Study ID Numbers: k （2018）39
• First Posted: Nov 21, 2018
• Last Update Posted: Feb 22, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hui-Sheng Chen, Department Chairman, General Hospital of Shenyang Military Region: rivaroxaban
• Additional relevant MeSH terms: Ischemic Stroke; Cerebral Infarction; Atrial Fibrillation; Infarction; Rivaroxaban

Study Results

No Results Posted as of Feb 22, 2022