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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-29

Study Completion Date

2026-01-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Ischemic Stroke Atrial Fibrillation Stenosis, Carotid Intracranial Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Anticoagulation alone

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

Group Type ACTIVE_COMPARATOR

Anticoagulant Oral

Intervention Type DRUG

Anticoagulation alone

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

Group Type EXPERIMENTAL

Anticoagulation combined with antiplatelet therapy

Intervention Type DRUG

Anticoagulation combined with antiplatelet therapy

Interventions

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Anticoagulant Oral

Anticoagulation alone

Intervention Type DRUG

Anticoagulation combined with antiplatelet therapy

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No