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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06058130

Collaborator

(none)

2,171

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Ischemic Stroke Atrial Fibrillation Stenosis, Carotid Intracranial Atherosclerosis	Drug: Anticoagulant Oral Drug: Anticoagulation combined with antiplatelet therapy	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2171 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Combination of Antiplatelet and Anticoagulation for Acute Ischemic Stroke Patients Witn Concomitant Non-valvular Atrial Fibrillation and Extracranial/Intracranial Artery Stenosis

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2025

Anticipated Study Completion Date :

Jan 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Anticoagulation alone Rivaroxaban 20mg once daily or 15mg once daily / Dabigatran 110mg twice daily or 150mg twice daily	Drug: Anticoagulant Oral Anticoagulation alone
Experimental: Anticoagulation combined with antiplatelet therapy 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	Drug: Anticoagulation combined with antiplatelet therapy Anticoagulation combined with antiplatelet therapy

Arm

Intervention/Treatment

Active Comparator: Anticoagulation alone

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

Drug: Anticoagulant Oral

Anticoagulation alone

Experimental: Anticoagulation combined with antiplatelet therapy

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

Drug: Anticoagulation combined with antiplatelet therapy

Anticoagulation combined with antiplatelet therapy

Outcome Measures

Primary Outcome Measures

90-day Composite events [90 days]
Composite events including ischemic stroke, hemorrhagic stroke, myocardial infarction, systemic embolism, major extracranial hemorrhage, and vascular death within 90 days after enrollment

Secondary Outcome Measures

90-day ischemic stroke [90 days]
Ischemic stroke within 90 days after enrollment
90-day hemorrhagic stroke [90 days]
Hemorrhagic stroke within 90 days after enrollment
90-day myocardial infarction [90 days]
Myocardial infarction within 90 days after enrollment
90-day systemic embolism [90 days]
Systemic embolism within 90 days after enrollment
90-day major extracranial hemorrhage [90 days]
Major extracranial hemorrhage within 90 days after enrollment
90-day non-major bleeding [90 days]
Non-major bleeding within 90 days after enrollment
90-day vascular death [90 days]
Vascular death within 90 days after enrollment
90-day all-cause death [90 days]
All-cause death within 90 days after enrollment
Discharge mRS [At discharge, an average of 7 days]
Modified Rankin scale at discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.