Combining blood thinners for stroke patients with heart and artery issues
Combination of Antiplatelet and Anticoagulation for Acute Ischemic Stroke Patients Witn Concomitant Non-valvular Atrial Fibrillation and Extracranial/Intracranial Artery Stenosis
This study tests whether using a combination of blood thinners and anti-clotting medications can help stroke patients with heart and artery issues feel safer and healthier compared to just using blood thinners alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2171 (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 | NCT06058130 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the safety and effectiveness of using anticoagulation alone versus a combination of anticoagulation and antiplatelet therapy in patients suffering from acute ischemic stroke (AIS) who also have non-valvular atrial fibrillation (NVAF) and significant artery stenosis. Participants will be randomly assigned to one of the two treatment groups, and the primary outcome will be assessed through composite events occurring three months after enrollment. The study addresses the heightened risk of stroke in this patient population and the potential concerns regarding bleeding complications associated with combined therapies.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old who have experienced an acute ischemic stroke or transient ischemic attack within the last week and have a history of NVAF along with significant artery stenosis.
Not a fit: Patients with chronic renal dysfunction, severe hepatic injury, or those with contraindications to anticoagulation or antiplatelet therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment strategy for stroke patients with concurrent heart and artery conditions, potentially reducing the risk of future strokes.
How similar studies have performed: While the combination of anticoagulation and antiplatelet therapy has been explored in other contexts, this specific approach for AIS patients with NVAF and artery stenosis is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years old * Acute ischemic stroke or TIA with onset \< 7 days * Have a history or newly diagnosed as NVAF * Concomitant stenosis (\>50%) of carotid artery/intracranial artery, of which the ischemic lesion located within the territory 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 or antiplatelet therapy, e.g. severe intracranial hemorrhage * Myocardial infarction within 6 months before enrollment or received percutaneous coronary intervention in the past * Have or plan to receive CEA or CAS in the following 3 months * 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.