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

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ClinicalTrials.gov Identifier: NCT03749057
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : February 22, 2022
Sponsor:
Information provided by (Responsible Party):
Hui-Sheng Chen, General Hospital of Shenyang Military Region

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 20, 2018
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Arms and Interventions
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Arm Intervention/treatment
rivaroxaban
15-20 mg rivaroxaban daily
 Drug: Rivaroxaban
Rivaroxaban 15-20 mg daily


Outcome Measures
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Primary Outcome Measures :
  1. incidence of intracranial hemorrhage [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. incidence of early neurological deterioration [ Time Frame: 7 days ]
    2 or more increase in NIHSS

  2. recurrence of stroke or other vascular events [ Time Frame: 90 days ]
  3. bleeding event [ Time Frame: 90 days ]
    Any bleeding event except intracranial hemorrhage

  4. Serious adverse events [ Time Frame: 90 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03749057


Contacts
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Contact: Xinhong Wang, Doctor 15309885658 ext 024-28897512 450341972@qq.com
Contact: Yu Cui, Master 18842398646 ext 024-28897512 314486939@qq.com

Locations
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China
General Hospital of ShenYang Military Region Recruiting
Shenyang, China
Contact: Li Wang, Master         
Sponsors and Collaborators
General Hospital of Shenyang Military Region
Investigators
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Study Chair: Huisheng Chen, Doctor Neurology Department
More Information
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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: November 21, 2018    Key Record Dates
Last Update Posted: February 22, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hui-Sheng Chen, General Hospital of Shenyang Military Region:
rivaroxaban
Additional relevant MeSH terms:
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Ischemic Stroke
Cerebral Infarction
Atrial Fibrillation
Infarction
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Ischemia
Necrosis
Stroke
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Brain Infarction
Brain Ischemia
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants