Early Versus Late Initiation of Anticoagulation in Mild-to-moderate AIS Patients With NVAF

Second Affiliated Hospital, Zhejiang University, School of Medicine2,351 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

2,351

Conditions

Acute Ischemic Stroke Atrial Fibrillation

Interventions

Anticoagulation AgentsDRUG

Anticoagulation agents includes rivaroxaban, dabigatran, apixaban, and edoxaban.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, China

RECRUITING

Jiaxing Second Hospital

Jiaxing, China

RECRUITING

Outcomes

Primary Outcomes

Early neurological deterioration before discharge

NIHSS at discharge increase at least 2 points compared with NIHSS on admission

Time frame: At discharge, an average of 7 days

Secondary Outcomes

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

Time frame: 90 days

90-day ischemic stroke

Ischemic stroke within 90 days after enrollment

Time frame: 90 days

90-day hemorrhagic stroke

Hemorrhagic stroke within 90 days after enrollment

Time frame: 90 days

90-day myocardial infarction

Myocardial infarction within 90 days after enrollment

Time frame: 90 days

90-day systemic embolism

Systemic embolism within 90 days after enrollment

Time frame: 90 days

90-day major extracranial hemorrhage

Major extracranial hemorrhage within 90 days after enrollment

Time frame: 90 days

90-day non-major bleeding

Non-major bleeding within 90 days after enrollment

Time frame: 90 days

Central Contacts

Min Lou, PhD

CONTACT

+8613958007213 loumingxc@vip.sina.com

Data from ClinicalTrials.gov

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