Combination of Antiplatelet and Anticoagulation for AIS Patients Witn Concomitant NVAF and Extracranial/Intracranial Artery Stenosis (ALLY)

Zhejiang University

Status: Enrolling

Conditions: Intracranial Atherosclerosis; Atrial Fibrillation; Acute Ischemic Stroke; Stenosis, Carotid

Treatments: Drug: Anticoagulant Oral; Drug: Anticoagulation combined with antiplatelet therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06058130

ALLY

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,171 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,171 participants in 2 patient groups

Anticoagulation alone

Active Comparator group

Description:

Rivaroxaban 20mg once daily or 15mg once daily / Dabigatran 110mg twice daily or 150mg twice daily

Treatment:

Drug: Anticoagulant Oral

Anticoagulation combined with antiplatelet therapy

Experimental group

Description:

Rivaroxaban 20mg once daily or 15mg once daily or 10mg once daily / dabigatran 110mg twice daily or 150mg twice daily+ aspirin 100mg once daily / clopidogrel 75mg once daily / ticagrelor 90mg twice daily / cilostazol 100mg twice daily

Treatment:

Drug: Anticoagulation combined with antiplatelet therapy