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

Primary Purpose

Acute Ischemic Stroke, Atrial Fibrillation, Stenosis, Carotid

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Anticoagulant Oral
Anticoagulation combined with antiplatelet therapy
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Ischemic Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Second Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Anticoagulation alone

Anticoagulation combined with antiplatelet therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The rate of 90-day ischemic stroke
Ischemic stroke within 90 days after enrollment
The rate of 90-day hemorrhagic stroke
Hemorrhagic stroke within 90 days after enrollment
The rate of 90-day myocardial infarction
Myocardial infarction within 90 days after enrollment
The rate of 90-day systemic embolism
Systemic embolism within 90 days after enrollment
The rate of 90-day major extracranial hemorrhage
Major extracranial hemorrhage within 90 days after enrollment
The rate of 90-day non-major bleeding
Non-major bleeding within 90 days after enrollment
The rate of 90-day vascular death
Vascular death within 90 days after enrollment
The rate of 90-day all-cause death
All-cause death within 90 days after enrollment
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.

Full Information

First Posted
September 21, 2023
Last Updated
October 16, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT06058130
Brief Title
Combination of Antiplatelet and Anticoagulation for AIS Patients Witn Concomitant NVAF and Extracranial/Intracranial Artery Stenosis
Acronym
ALLY
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 29, 2023 (Actual)
Primary Completion Date
October 1, 2025 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke, Atrial Fibrillation, Stenosis, Carotid, Intracranial Atherosclerosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2171 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anticoagulation alone
Arm Type
Active Comparator
Arm Description
Rivaroxaban 20mg once daily or 15mg once daily / Dabigatran 110mg twice daily or 150mg twice daily
Arm Title
Anticoagulation combined with antiplatelet therapy
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Anticoagulant Oral
Intervention Description
Anticoagulation alone
Intervention Type
Drug
Intervention Name(s)
Anticoagulation combined with antiplatelet therapy
Intervention Description
Anticoagulation combined with antiplatelet therapy
Primary Outcome Measure Information:
Title
The rate of 90-day Composite events
Description
Composite events including ischemic stroke, hemorrhagic stroke, myocardial infarction, systemic embolism, major extracranial hemorrhage, and vascular death within 90 days after enrollment
Time Frame
90 days
Secondary Outcome Measure Information:
Title
The rate of 90-day ischemic stroke
Description
Ischemic stroke within 90 days after enrollment
Time Frame
90 days
Title
The rate of 90-day hemorrhagic stroke
Description
Hemorrhagic stroke within 90 days after enrollment
Time Frame
90 days
Title
The rate of 90-day myocardial infarction
Description
Myocardial infarction within 90 days after enrollment
Time Frame
90 days
Title
The rate of 90-day systemic embolism
Description
Systemic embolism within 90 days after enrollment
Time Frame
90 days
Title
The rate of 90-day major extracranial hemorrhage
Description
Major extracranial hemorrhage within 90 days after enrollment
Time Frame
90 days
Title
The rate of 90-day non-major bleeding
Description
Non-major bleeding within 90 days after enrollment
Time Frame
90 days
Title
The rate of 90-day vascular death
Description
Vascular death within 90 days after enrollment
Time Frame
90 days
Title
The rate of 90-day all-cause death
Description
All-cause death within 90 days after enrollment
Time Frame
90 days
Title
Discharge modified Rankin scale score
Description
Modified Rankin scale (mRS) at discharge. MRS ranges from 0 to 6, with a higher score indicating worse functional outcome.
Time Frame
At discharge, an average of 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Lou, PhD
Phone
+8613958007213
Email
loumingxc@vip.sina.com
Facility Information:
Facility Name
Second Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Lou, PhD
Email
loumingxc@vip.sina.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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