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The goal of this clinical trial is to compare the effectiveness between early and late initiation of anticoagulation therapy in acute ischemic stroke (AIS) patients with non-valvular atrial fibrillation (NVAF). Participants will be 1:1 randomized into early or late initiation group. The primary endpoint is early neurological deterioration (END) before discharge.
Anticoagulation therapy is effective to prevent ischemic stroke in patients with NVAF who have a history of stroke. Recent clinical trials have demonstrated that early initiation of anticoagulation therapy after AIS is safe, while no remarkable benefits have been observed. The goal of this clinical trial is to compare the effectiveness between early and late initiation of anticoagulation therapy in AIS patients with non-NVAF. Participants will be 1:1 randomized into early or late initiation group. The primary endpoint is END before discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early initiation of anticoagulation | Experimental | For patients with NIHSS 0-3, anticoagulation therapy will be initiated within 0-3 days of onset. For patients with NIHSS 4-8, anticoagulation therapy will be initiated within 4-6 days of onset. |
|
| Late initiation of anticoagulation | Active Comparator | For patients with NIHSS 0-3, anticoagulation therapy will be initiated within 4-12 days of onset. For patients with NIHSS 4-8, anticoagulation therapy will be initiated within 7-12 days of onset. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anticoagulation Agents | Drug | Anticoagulation agents includes rivaroxaban, dabigatran, apixaban, and edoxaban. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Early neurological deterioration before discharge | NIHSS at discharge increase at least 2 points compared with NIHSS on admission | At discharge, an average of 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 90-day ischemic stroke |
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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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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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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Ischemic stroke within 90 days after enrollment
| 90 days |
| 90-day hemorrhagic stroke | Hemorrhagic stroke within 90 days after enrollment | 90 days |
| 90-day myocardial infarction | Myocardial infarction within 90 days after enrollment | 90 days |
| 90-day systemic embolism | Systemic embolism within 90 days after enrollment | 90 days |
| 90-day major extracranial hemorrhage | Major extracranial hemorrhage within 90 days after enrollment | 90 days |
| 90-day non-major bleeding | Non-major bleeding within 90 days after enrollment | 90 days |
| 90-day vascular death | Vascular death within 90 days after enrollment | 90 days |
| 90-day all-cause death | All-cause death within 90 days after enrollment | 90 days |
| Discharge mRS | Modified Rankin scale at discharge | At discharge, an average of 7 days |
| Jiaxing Second Hospital | Recruiting | Jiaxing | China |
|
| 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 |