Atrial Fibrillation Clinical Trial
— ALLYOfficial title:
Combination of Antiplatelet and Anticoagulation for Acute Ischemic Stroke Patients Witn Concomitant Non-valvular Atrial Fibrillation and Extracranial/Intracranial Artery Stenosis
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.
Status | Recruiting |
Enrollment | 2171 |
Est. completion date | January 1, 2026 |
Est. primary completion date | October 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Second Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | |
China | Jiaxing Second Hospital | Jiaxing |
Lead Sponsor | Collaborator |
---|---|
Second Affiliated Hospital, School of Medicine, Zhejiang University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | The rate of 90-day ischemic stroke | Ischemic stroke within 90 days after enrollment | 90 days | |
Secondary | The rate of 90-day hemorrhagic stroke | Hemorrhagic stroke within 90 days after enrollment | 90 days | |
Secondary | The rate of 90-day myocardial infarction | Myocardial infarction within 90 days after enrollment | 90 days | |
Secondary | The rate of 90-day systemic embolism | Systemic embolism within 90 days after enrollment | 90 days | |
Secondary | The rate of 90-day major extracranial hemorrhage | Major extracranial hemorrhage within 90 days after enrollment | 90 days | |
Secondary | The rate of 90-day non-major bleeding | Non-major bleeding within 90 days after enrollment | 90 days | |
Secondary | The rate of 90-day vascular death | Vascular death within 90 days after enrollment | 90 days | |
Secondary | The rate of 90-day all-cause death | All-cause death within 90 days after enrollment | 90 days | |
Secondary | 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 |
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