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

Not Applicable

Recruiting

• Conditions: Acute Ischemic Stroke; Atrial Fibrillation
• Interventions: Drug: Anticoagulation Agents

• Registration Number: NCT06057467
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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 Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-13
• Study Start: 2023-09-15
• Study First Submitted QC: 2023-09-21
• Study First Posted: 2023-09-28
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-18
• Primary Completion: 2025-10-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2351

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early initiation of anticoagulation	Anticoagulation Agents	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.
Late initiation of anticoagulation	Anticoagulation Agents	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
90-day ischemic stroke	90 days	Ischemic stroke within 90 days after enrollment
90-day systemic embolism	90 days	Systemic embolism within 90 days after enrollment
90-day non-major bleeding	90 days	Non-major bleeding within 90 days after enrollment
Discharge mRS	At discharge, an average of 7 days	Modified Rankin scale at discharge
90-day hemorrhagic stroke	90 days	Hemorrhagic stroke within 90 days after enrollment
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
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 myocardial infarction	90 days	Myocardial infarction within 90 days after enrollment
90-day major extracranial hemorrhage	90 days	Major extracranial hemorrhage within 90 days after enrollment

Trial Locations

Locations (2)

Second Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, China

Jiaxing Second Hospital; 🇨🇳 Jiaxing, China