Combination of Antiplatelet and Anticoagulation for AIS Patients Witn Concomitant NVAF and Extracranial/Intracranial Artery Stenosis
Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Sep 21, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how safe and effective a combination of blood-thinning medications (anticoagulants) and anti-clotting drugs (antiplatelet therapy) is for patients who have had an acute ischemic stroke (which happens when blood flow to the brain is blocked) and also have a specific heart condition called non-valvular atrial fibrillation (NVAF), along with narrowing of the arteries in the neck or brain. The researchers will randomly place participants in one of two groups: one will receive only the anticoagulant, while the other will receive both the anticoagulant and the antiplatelet therapy. They will track participants for three months to see how well these treatments work and how safe they are.
To be eligible for the trial, participants need to be at least 18 years old and have experienced a stroke or a transient ischemic attack (a mini-stroke) within the last week. They must also have a history of NVAF and significant narrowing of the carotid or intracranial arteries. However, individuals with certain health issues, such as severe kidney or liver problems, recent heart attacks, or those who are pregnant or planning to have major surgery soon, may not qualify. Participants will be closely monitored during the trial, and the results may help improve treatment options for future patients with similar conditions.
Gender
ALL
Eligibility 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.
About Second Affiliated Hospital, School Of Medicine, Zhejiang University
The Second Affiliated Hospital of Zhejiang University School of Medicine is a leading clinical research institution dedicated to advancing healthcare through innovative medical practices and rigorous scientific inquiry. With a robust infrastructure and a multidisciplinary team of experienced researchers and clinicians, the hospital is committed to conducting high-quality clinical trials that address critical health challenges. As an integral part of Zhejiang University, the hospital leverages academic expertise and cutting-edge technology to foster collaboration in research, education, and patient care, ultimately aiming to improve patient outcomes and contribute to the global medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Hangzhou, , China
Jiaxing, , China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported