Using Rivaroxaban for Patients with Atrial Fibrillation After Stroke
Early Rivaroxaban for Acute Ischemic Stroke or TIA Patients With Atrial Fibrillation: a Prospective, Multicenter, Cohort Study
PHASE4 · General Hospital of Shenyang Military Region · NCT03749057
This study is testing if starting the blood thinner Rivaroxaban at the right time can help patients with atrial fibrillation who have had a stroke or mini-stroke feel better and prevent future strokes.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | General Hospital of Shenyang Military Region (other) |
| Locations | 1 site (Shenyang) |
| Trial ID | NCT03749057 on ClinicalTrials.gov |
What this trial studies
This study investigates the timing and effectiveness of administering the anticoagulant Rivaroxaban to patients with acute ischemic stroke or transient ischemic attack (TIA) who also have non-valvular atrial fibrillation. It aims to determine the optimal time frame for starting treatment based on various factors such as stroke severity and patient comorbidities. The study will include patients who are within 12 days of symptom onset and have a specific NIHSS score. By addressing the uncertainties surrounding the initiation of anticoagulant therapy, this research seeks to improve stroke prevention strategies.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have experienced an acute cerebral infarction due to non-valvular atrial fibrillation within the last 12 days.
Not a fit: Patients with hemorrhagic stroke, valvular atrial fibrillation, or those with severe comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment protocols for stroke prevention in patients with atrial fibrillation, potentially reducing the risk of future strokes.
How similar studies have performed: Other studies have explored anticoagulant therapy in similar contexts, but this specific timing approach with Rivaroxaban is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: 1. Over 18 years 2. Acute cerebral infarction caused by non-valvular atrial fibrillation 3. NIHSS score ≤ 15 4. Within 12 days of onset 5. first stroke onset or past stroke without obvious neurological deficit (mRS score≤1) 6. Signed informed consent Exclusion Criteria: 1. Hemorrhagic stroke or mixed stroke 2. Patients with valvular atrial fibrillation or non-cardiogenic cerebral infarction 3. Patients with severe infection or serious diseases 4. Gastrointestinal bleeding or major operation within 3 months 5. Planed cerebrovascular reconstruction or cardiac surgery within 3 months 6. Planed major surgery within 3 months 7. Participating in other clinical trials within 3 months 8. Unsuitable for this trial assessed by research
Where this trial is running
Shenyang
- General Hospital of ShenYang Military Region — Shenyang, China (RECRUITING)
Study contacts
- Study coordinator: Xinhong Wang, Doctor
- Email: 450341972@qq.com
- Phone: 15309885658
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.
Conditions: Cerebral Infarction, TIA, rivaroxaban