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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation; Acute Ischemic Stroke; Intracranial Atherosclerosis; Stenosis, Carotid
• Intervention / Treatment: Drug: Anticoagulant Oral; Drug: Anticoagulation combined with antiplatelet therapy

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 Type: Interventional
• Enrollment (Estimated): 2171
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Min Lou, PhD; Phone Number: +8613958007213; Email: loumingxc@vip.sina.com

Study Locations

• China
  • Hangzhou, China
    • Recruiting
    • Second Affiliated Hospital, School of Medicine, Zhejiang University
    • Contact: Min Lou, PhD; Email: loumingxc@vip.sina.com
  • Jiaxing, China
    • Recruiting
    • Jiaxing Second Hospital
    • Contact: Xiaoling Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of 90-day Composite events	Composite events including ischemic stroke, hemorrhagic stroke, myocardial infarction, systemic embolism, major extracranial hemorrhage, and vascular death within 90 days after enrollment	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of 90-day ischemic stroke	Ischemic stroke within 90 days after enrollment	90 days
The rate of 90-day hemorrhagic stroke	Hemorrhagic stroke within 90 days after enrollment	90 days
The rate of 90-day myocardial infarction	Myocardial infarction within 90 days after enrollment	90 days
The rate of 90-day systemic embolism	Systemic embolism within 90 days after enrollment	90 days
The rate of 90-day major extracranial hemorrhage	Major extracranial hemorrhage within 90 days after enrollment	90 days
The rate of 90-day non-major bleeding	Non-major bleeding within 90 days after enrollment	90 days
The rate of 90-day vascular death	Vascular death within 90 days after enrollment	90 days
The rate of 90-day all-cause death	All-cause death within 90 days after enrollment	90 days
Discharge modified Rankin scale score	Modified Rankin scale (mRS) at discharge. MRS ranges from 0 to 6, with a higher score indicating worse functional outcome.	At discharge, an average of 7 days

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2023
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: September 21, 2023
• First Submitted That Met QC Criteria: September 21, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Arrhythmias, Cardiac; Carotid Artery Diseases; Stroke; Intracranial Arterial Diseases; Ischemic Stroke; Atrial Fibrillation; Carotid Stenosis; Constriction, Pathologic; Atherosclerosis; Intracranial Arteriosclerosis; Anticoagulants
• Other Study ID Numbers: ALLY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No