Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06058130
Other study ID # ALLY
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Terminated NCT04115735 - His Bundle Recording From Subclavian Vein
Completed NCT04571385 - A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF) Phase 2
Completed NCT05366803 - Women's Health Initiative Silent Atrial Fibrillation Recording Study N/A
Completed NCT02864758 - Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
Recruiting NCT05442203 - Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease N/A
Completed NCT05599308 - Evaluation of Blood Pressure Monitor With AFib Screening Feature N/A
Completed NCT03790917 - Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
Enrolling by invitation NCT05890274 - Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO N/A
Recruiting NCT05316870 - Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation N/A
Recruiting NCT05266144 - Atrial Fibrillation Patients Treated With Catheter Ablation
Not yet recruiting NCT06023784 - The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Recruiting NCT04092985 - Smart Watch iECG for the Detection of Cardiac Arrhythmias
Completed NCT04087122 - Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures N/A
Completed NCT06283654 - Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
Recruiting NCT05416086 - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study N/A
Completed NCT05067114 - Solutions for Atrial Fibrillation Edvocacy (SAFE)
Completed NCT04546763 - Study Watch AF Detection At Home
Completed NCT03761394 - Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke N/A