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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anticoagulation alone | Active Comparator | Rivaroxaban 20mg once daily or 15mg once daily / Dabigatran 110mg twice daily or 150mg twice daily |
|
| Anticoagulation combined with antiplatelet therapy | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anticoagulant Oral | Drug | Anticoagulation alone |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Lou, PhD | Contact | +8613958007213 | loumingxc@vip.sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | Hangzhou | China |
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| Anticoagulation combined with antiplatelet therapy |
| Drug |
Anticoagulation combined with antiplatelet therapy |
|
| 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 |
| Jiaxing Second Hospital | Recruiting | Jiaxing | China |
|
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D001281 | Atrial Fibrillation |
| D016893 | Carotid Stenosis |
| D002537 | Intracranial Arteriosclerosis |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002340 | Carotid Artery Diseases |
| D001157 | Arterial Occlusive Diseases |
| D020765 | Intracranial Arterial Diseases |
| D001161 | Arteriosclerosis |
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| ID | Term |
|---|---|
| D000925 | Anticoagulants |
| ID | Term |
|---|---|
| D006401 | Hematologic Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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