Clinical trial NCT06058130: Combination of Antiplatelet and Anticoagulation for AIS Patients Witn Concomitant NVAF and Extracranial/Intracranial Artery Stenosis
Official title: Combination of Antiplatelet and Anticoagulation for Acute Ischemic Stroke Patients Witn Concomitant Non-valvular Atrial Fibrillation and Extracranial/Intracranial Artery Stenosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Ischemic Stroke
Atrial Fibrillation
Stenosis, Carotid
Intracranial Atherosclerosis
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 2171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to compare the safety and effectiveness of anticoagulation combined with antiplatelet therapy in acute ischemic stroke (AIS) patients with concomitant non-valvular atrial fibrillation (NVAF) and extracranial/intracranial artery stenosis. Participants will be 1:1 randomized into anticoagulation alone or anticoagulation combined with antiplatelet therapy. The primary endpoint is composite events 3 months after enrollment.

Detailed description: Concomitant NVAF and extracranial/intracranial artery stenosis will greatly increase the risk of stroke, even with standard anticoagulation. However, clinicians may be concerned with the high risk of bleeding complications of anticoagulation combined with antiplatelet therapy. The goal of this clinical trial is to evaluate the safety and effectiveness of anticoagulation combined with antiplatelet therapy in acute ischemic stroke (AIS) patients with concomitant non-valvular atrial fibrillation (NVAF) and extracranial/intracranial artery stenosis. Participants will be 1:1 randomized into anticoagulation alone or anticoagulation combined with antiplatelet therapy. The primary endpoint is composite events 3 months after enrollment.

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.

Primary outcomes:
measure: The rate of 90-day Composite events
timeFrame: 90 days
Secondary outcomes:
measure: The rate of 90-day ischemic stroke
timeFrame: 90 days
measure: The rate of 90-day hemorrhagic stroke
timeFrame: 90 days
measure: The rate of 90-day myocardial infarction
timeFrame: 90 days
measure: The rate of 90-day systemic embolism
timeFrame: 90 days
measure: The rate of 90-day major extracranial hemorrhage
timeFrame: 90 days
measure: The rate of 90-day non-major bleeding
timeFrame: 90 days
measure: The rate of 90-day vascular death
timeFrame: 90 days
measure: The rate of 90-day all-cause death
timeFrame: 90 days
measure: Discharge modified Rankin scale score
timeFrame: At discharge, an average of 7 days
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
city: Jiaxing
country: China
facility: Jiaxing Second Hospital
Study officials:
References: