Acute Ischemic Stroke, Atrial Fibrillation, Intracranial Atherosclerosis, Stenosis, Carotid
Conditions
Brief summary
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
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.
Interventions
Anticoagulation alone
DRUGAnticoagulation combined with antiplatelet therapy
Anticoagulation combined with antiplatelet therapy
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of 90-day Composite events | 90 days | Composite events including ischemic stroke, hemorrhagic stroke, myocardial infarction, systemic embolism, major extracranial hemorrhage, and vascular death within 90 days after enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The rate of 90-day hemorrhagic stroke | 90 days | Hemorrhagic stroke within 90 days after enrollment |
| The rate of 90-day myocardial infarction | 90 days | Myocardial infarction within 90 days after enrollment |
| The rate of 90-day systemic embolism | 90 days | Systemic embolism within 90 days after enrollment |
| The rate of 90-day major extracranial hemorrhage | 90 days | Major extracranial hemorrhage within 90 days after enrollment |
| The rate of 90-day ischemic stroke | 90 days | Ischemic stroke within 90 days after enrollment |
| The rate of 90-day vascular death | 90 days | Vascular death within 90 days after enrollment |
| The rate of 90-day all-cause death | 90 days | All-cause death within 90 days after enrollment |
| Discharge modified Rankin scale score | At discharge, an average of 7 days | Modified Rankin scale (mRS) at discharge. MRS ranges from 0 to 6, with a higher score indicating worse functional outcome. |
| The rate of 90-day non-major bleeding | 90 days | Non-major bleeding within 90 days after enrollment |
Countries
China
Contacts
Primary ContactMin Lou, PhD
Outcome results
None listed