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

Not Applicable

Recruiting

• Conditions: Acute Ischemic Stroke; Atrial Fibrillation; Stenosis, Carotid; Intracranial Atherosclerosis
• Interventions: Drug: Anticoagulant Oral; Drug: Anticoagulation combined with antiplatelet therapy

• Registration Number: NCT06058130
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-21
• Study First Submitted QC: 2023-09-21
• Study First Posted: 2023-09-28
• Study Start: 2023-09-29
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-18
• Primary Completion: 2025-10-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2171

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anticoagulation alone	Anticoagulant Oral	Rivaroxaban 20mg once daily or 15mg once daily / Dabigatran 110mg twice daily or 150mg twice daily
Anticoagulation combined with antiplatelet therapy	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

Primary Outcome Measures

Name	Time	Method
The rate of 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

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

Trial Locations

Locations (2)

Second Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, China

Jiaxing Second Hospital; 🇨🇳 Jiaxing, China