Comparing early and late anticoagulation for stroke patients with atrial fibrillation
Early Versus Late Initiation of Anticoagulation in Mild-to-moderate Acute Ischemic Stroke Patients With Non-valvular Atrial Fibrillation
This study is testing whether starting blood-thinning medicine earlier or later can help stroke patients with atrial fibrillation have better outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2351 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 2 sites (Hangzhou and 1 other locations) |
| Trial ID | NCT06057467 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of early versus late initiation of anticoagulation therapy in patients with mild-to-moderate acute ischemic stroke (AIS) who also have non-valvular atrial fibrillation (NVAF). Participants will be randomly assigned to either an early or late initiation group, with the primary endpoint being early neurological deterioration before discharge. The study seeks to determine if the timing of anticoagulation therapy can influence patient outcomes in this specific population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have experienced an acute ischemic stroke within the last 48 hours and have a history or diagnosis of non-valvular atrial fibrillation.
Not a fit: Patients with chronic renal dysfunction, severe hepatic injury, or those who have contraindications to anticoagulation therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for stroke patients with atrial fibrillation, potentially reducing the risk of neurological deterioration.
How similar studies have performed: While recent trials have shown safety in early anticoagulation initiation, the effectiveness remains unproven, making this approach novel and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hangzhou and 1 other locations
- Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, China (Recruiting)
- Jiaxing Second Hospital — Jiaxing, China (Recruiting)
Study contacts
- Study coordinator: Min Lou, PhD
- Email: loumingxc@vip.sina.com
- Phone: +8613958007213
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.