Early Versus Late Initiation of Anticoagulation in Mild-to-moderate Acute Ischemic Stroke Patients With Non-valvular Atrial Fibrillation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 2,351
- Locations
- 2
- Primary Endpoint
- Early neurological deterioration before discharge
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Early initiation of anticoagulation
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.
Intervention: Anticoagulation Agents (Drug)
Late initiation of anticoagulation
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.
Intervention: Anticoagulation Agents (Drug)
Outcomes
Primary Outcomes
Early neurological deterioration before discharge
Time Frame: At discharge, an average of 7 days
NIHSS at discharge increase at least 2 points compared with NIHSS on admission
Secondary Outcomes
- 90-day hemorrhagic stroke(90 days)
- 90-day ischemic stroke(90 days)
- 90-day systemic embolism(90 days)
- 90-day non-major bleeding(90 days)
- Discharge mRS(At discharge, an average of 7 days)
- 90-day vascular death(90 days)
- 90-day all-cause death(90 days)
- 90-day Composite events(90 days)
- 90-day myocardial infarction(90 days)
- 90-day major extracranial hemorrhage(90 days)