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

Zhejiang University

Status: Enrolling

Conditions: Atrial Fibrillation; Acute Ischemic Stroke

Treatments: Drug: Anticoagulation Agents

Study type: Interventional

Funder types: Other

Identifiers

NCT06057467

ASAP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,351 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

2,351 participants in 2 patient groups

Early initiation of anticoagulation

Experimental group

Description:

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.

Treatment:

Drug: Anticoagulation Agents

Late initiation of anticoagulation

Active Comparator group

Description:

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.

Treatment:

Drug: Anticoagulation Agents