Combination of Antiplatelet and Anticoagulation for AIS Patients Witn Concomitant NVAF and Extracranial/Intracranial Artery Stenosis

Study Overview
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Brief Summary
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The goal of this clinical trial is to compare the safety and effectiveness of anticoagulation combined with antiplatelet therapy in acute ischemic stroke (AIS) patients with concomitant non-valvular atrial fibrillation (NVAF) and extracranial/intracranial artery stenosis. Participants will be 1:1 randomized into anticoagulation alone or anticoagulation combined with antiplatelet therapy. The primary endpoint is composite events 3 months after enrollment.

Detailed Description
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Concomitant NVAF and extracranial/intracranial artery stenosis will greatly increase the risk of stroke, even with standard anticoagulation. However, clinicians may be concerned with the high risk of bleeding complications of anticoagulation combined with antiplatelet therapy. The goal of this clinical trial is to evaluate the safety and effectiveness of anticoagulation combined with antiplatelet therapy in acute ischemic stroke (AIS) patients with concomitant non-valvular atrial fibrillation (NVAF) and extracranial/intracranial artery stenosis. Participants will be 1:1 randomized into anticoagulation alone or anticoagulation combined with antiplatelet therapy. The primary endpoint is composite events 3 months after enrollment.

Official Title
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Combination of Antiplatelet and Anticoagulation for Acute Ischemic Stroke Patients Witn Concomitant Non-valvular Atrial Fibrillation and Extracranial/Intracranial Artery Stenosis

Conditions
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Acute Ischemic Stroke, Atrial Fibrillation, Stenosis, Carotid, Intracranial Atherosclerosis

Intervention / Treatment
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* Drug: Anticoagulant Oral
* Drug: Anticoagulation combined with antiplatelet therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years old Acute ischemic stroke or TIA with onset < 7 days Have a history or newly diagnosed as NVAF Concomitant stenosis (>50%) of carotid artery/intracranial artery, of which the ischemic lesion located within the territory Exclusion Criteria: Chronic renal dysfunction (GFR < 30ml/min) or severe hepatic injury Have a history or newly diagnosed as valvular heart disease Mural thrombus in heart Contraindications of anticoagulation or antiplatelet therapy, e.g. severe intracranial hemorrhage Myocardial infarction within 6 months before enrollment or received percutaneous coronary intervention in the past Have or plan to receive CEA or CAS in the following 3 months Life expectancy less than 1 year Plan to receive invasive surgery in the following 3 months and have high risk of uncontrollable bleeding Pregnant or lactating women Individuals identified by researchers as unsuitable for participation in the study due to other reasons.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Anticoagulation alone<br>Rivaroxaban 20mg once daily or 15mg once daily / Dabigatran 110mg twice daily or 150mg twice daily | Drug: Anticoagulant Oral<br>* Anticoagulation alone<br>|
| Experimental: Anticoagulation combined with antiplatelet therapy<br>Rivaroxaban 20mg once daily or 15mg once daily or 10mg once daily / dabigatran 110mg twice daily or 150mg twice daily+ aspirin 100mg once daily / clopidogrel 75mg once daily / ticagrelor 90mg twice daily / cilostazol 100mg twice daily | Drug: Anticoagulation combined with antiplatelet therapy<br>* Anticoagulation combined with antiplatelet therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of 90-day Composite events | Composite events including ischemic stroke, hemorrhagic stroke, myocardial infarction, systemic embolism, major extracranial hemorrhage, and vascular death within 90 days after enrollment | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of 90-day ischemic stroke | Ischemic stroke within 90 days after enrollment | 90 days | 
| The rate of 90-day hemorrhagic stroke | Hemorrhagic stroke within 90 days after enrollment | 90 days | 
| The rate of 90-day myocardial infarction | Myocardial infarction within 90 days after enrollment | 90 days | 
| The rate of 90-day systemic embolism | Systemic embolism within 90 days after enrollment | 90 days | 
| The rate of 90-day major extracranial hemorrhage | Major extracranial hemorrhage within 90 days after enrollment | 90 days | 
| The rate of 90-day non-major bleeding | Non-major bleeding within 90 days after enrollment | 90 days | 
| The rate of 90-day vascular death | Vascular death within 90 days after enrollment | 90 days | 
| The rate of 90-day all-cause death | All-cause death within 90 days after enrollment | 90 days | 
| Discharge modified Rankin scale score | Modified Rankin scale (mRS) at discharge. MRS ranges from 0 to 6, with a higher score indicating worse functional outcome. | At discharge, an average of 7 days |