Acute Ischemic Stroke, Atrial Fibrillation
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Anticoagulation agents includes rivaroxaban, dabigatran, apixaban, and edoxaban.
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 with onset \< 48 hours * Have a history or newly diagnosed as NVAF * NIHSS on admission \<= 8
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 therapy within 12 days after AIS, e.g. severe intracranial hemorrhage * Received reperfusion therapy, e.g. intravenous thrombolysis and endovascular treatment * Concomitant stenosis (\>50%) of carotid artery/intracranial artery, of which the ischemic lesion located within the territory * 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 |
|---|---|---|
| Early neurological deterioration before discharge | At discharge, an average of 7 days | NIHSS at discharge increase at least 2 points compared with NIHSS on admission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 90-day vascular death | 90 days | Vascular death within 90 days after enrollment |
| 90-day all-cause death | 90 days | All-cause death within 90 days after enrollment |
| Discharge mRS | At discharge, an average of 7 days | Modified Rankin scale at discharge |
| 90-day ischemic stroke | 90 days | Ischemic stroke within 90 days after enrollment |
| 90-day non-major bleeding | 90 days | Non-major bleeding within 90 days after enrollment |
| 90-day myocardial infarction | 90 days | Myocardial infarction within 90 days after enrollment |
| 90-day systemic embolism | 90 days | Systemic embolism within 90 days after enrollment |
| 90-day major extracranial hemorrhage | 90 days | Major extracranial hemorrhage within 90 days after enrollment |
| 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 |
| 90-day hemorrhagic stroke | 90 days | Hemorrhagic stroke within 90 days after enrollment |
Countries
China
Contacts
Primary ContactMin Lou, PhD
Outcome results
None listed