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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2351 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-15

Study Completion Date

2026-01-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Ischemic Stroke Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Early initiation of anticoagulation

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.

Group Type EXPERIMENTAL

Anticoagulation Agents

Intervention Type DRUG

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

Late initiation of anticoagulation

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.

Group Type ACTIVE_COMPARATOR

Anticoagulation Agents

Intervention Type DRUG

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

Interventions

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Anticoagulation Agents

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No