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

Atrial Fibrillation Clinical Trial

— ASAP  

Official title:

Early Versus Late Initiation of Anticoagulation in Mild-to-moderate Acute Ischemic Stroke Patients With Non-valvular Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06057467
• Other study ID #: ASAP
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: January 1, 2026

Study information

• Verified date: September 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Min Lou, PhD
• Phone: +8613958007213
• Email: loumingxc[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2351
• Est. completion date: January 1, 2026
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Atrial Fibrillation
• Ischemic Stroke

Intervention

Drug:
• Anticoagulation Agents
Anticoagulation agents includes rivaroxaban, dabigatran, apixaban, and edoxaban.

Locations

Country	Name	City	State
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou
China	Jiaxing Second Hospital	Jiaxing

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early neurological deterioration before discharge	NIHSS at discharge increase at least 2 points compared with NIHSS on admission	At discharge, an average of 7 days
Secondary	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	90 days
Secondary	90-day ischemic stroke	Ischemic stroke within 90 days after enrollment	90 days
Secondary	90-day hemorrhagic stroke	Hemorrhagic stroke within 90 days after enrollment	90 days
Secondary	90-day myocardial infarction	Myocardial infarction within 90 days after enrollment	90 days
Secondary	90-day systemic embolism	Systemic embolism within 90 days after enrollment	90 days
Secondary	90-day major extracranial hemorrhage	Major extracranial hemorrhage within 90 days after enrollment	90 days
Secondary	90-day non-major bleeding	Non-major bleeding within 90 days after enrollment	90 days
Secondary	90-day vascular death	Vascular death within 90 days after enrollment	90 days
Secondary	90-day all-cause death	All-cause death within 90 days after enrollment	90 days
Secondary	Discharge mRS	Modified Rankin scale at discharge	At discharge, an average of 7 days