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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
2,171
Anticoagulation alone
Anticoagulation combined with antiplatelet therapy
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, China
RECRUITINGJiaxing Second Hospital
Jiaxing, China
RECRUITINGThe 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
Time frame: 90 days
The rate of 90-day ischemic stroke
Ischemic stroke within 90 days after enrollment
Time frame: 90 days
The rate of 90-day hemorrhagic stroke
Hemorrhagic stroke within 90 days after enrollment
Time frame: 90 days
The rate of 90-day myocardial infarction
Myocardial infarction within 90 days after enrollment
Time frame: 90 days
The rate of 90-day systemic embolism
Systemic embolism within 90 days after enrollment
Time frame: 90 days
The rate of 90-day major extracranial hemorrhage
Major extracranial hemorrhage within 90 days after enrollment
Time frame: 90 days
The rate of 90-day non-major bleeding
Non-major bleeding within 90 days after enrollment
Time frame: 90 days
The rate of 90-day vascular death
Vascular death within 90 days after enrollment
Time frame: 90 days
The rate of 90-day all-cause death
All-cause death within 90 days after enrollment
Time frame: 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.
Time frame: At discharge, an average of 7 days
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