Clinical trial NCT06057467: Early Versus Late Initiation of Anticoagulation in Mild-to-moderate AIS Patients With NVAF
Official title: Early Versus Late Initiation of Anticoagulation in Mild-to-moderate Acute Ischemic Stroke Patients With Non-valvular Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Ischemic Stroke
Atrial Fibrillation
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 2351
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Early neurological deterioration before discharge
timeFrame: At discharge, an average of 7 days
Secondary outcomes:
measure: 90-day Composite events
timeFrame: 90 days
measure: 90-day ischemic stroke
timeFrame: 90 days
measure: 90-day hemorrhagic stroke
timeFrame: 90 days
measure: 90-day myocardial infarction
timeFrame: 90 days
measure: 90-day systemic embolism
timeFrame: 90 days
measure: 90-day major extracranial hemorrhage
timeFrame: 90 days
measure: 90-day non-major bleeding
timeFrame: 90 days
measure: 90-day vascular death
timeFrame: 90 days
measure: 90-day all-cause death
timeFrame: 90 days
measure: Discharge mRS
timeFrame: At discharge, an average of 7 days
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
city: Jiaxing
country: China
facility: Jiaxing Second Hospital
Study officials:
References: