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

Atrial Fibrillation Clinical Trial

— ALLY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06058130
• Other study ID #: ALLY
• Status: Recruiting
• Phase: N/A
• Start date: September 29, 2023
• Est. completion date: January 1, 2026

Study information

• Verified date: September 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Min Lou, PhD
• Phone: +8613958007213
• Email: loumingxc[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2171
• Est. completion date: January 1, 2026
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Atherosclerosis
• Atrial Fibrillation
• Carotid Stenosis
• Constriction, Pathologic
• Intracranial Arteriosclerosis
• Intracranial Atherosclerosis
• Ischemic Stroke
• Stenosis, Carotid

Intervention

Drug:
• Anticoagulant Oral
Anticoagulation alone
• Anticoagulation combined with antiplatelet therapy
Anticoagulation combined with antiplatelet therapy

Locations

Country	Name	City	State
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou
China	Jiaxing Second Hospital	Jiaxing

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The rate of 90-day ischemic stroke	Ischemic stroke within 90 days after enrollment	90 days
Secondary	The rate of 90-day hemorrhagic stroke	Hemorrhagic stroke within 90 days after enrollment	90 days
Secondary	The rate of 90-day myocardial infarction	Myocardial infarction within 90 days after enrollment	90 days
Secondary	The rate of 90-day systemic embolism	Systemic embolism within 90 days after enrollment	90 days
Secondary	The rate of 90-day major extracranial hemorrhage	Major extracranial hemorrhage within 90 days after enrollment	90 days
Secondary	The rate of 90-day non-major bleeding	Non-major bleeding within 90 days after enrollment	90 days
Secondary	The rate of 90-day vascular death	Vascular death within 90 days after enrollment	90 days
Secondary	The rate of 90-day all-cause death	All-cause death within 90 days after enrollment	90 days
Secondary	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