NCT06058130

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,171

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

September 29, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

March 18, 2024

Status Verified

September 1, 2023

Enrollment Period

2 years

First QC Date

September 21, 2023

Last Update Submit

March 15, 2024

Conditions

Acute Ischemic StrokeAtrial FibrillationStenosis, CarotidIntracranial Atherosclerosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • The rate of 90-day ischemic stroke

    90 days

  • The rate of 90-day hemorrhagic stroke

    90 days

  • The rate of 90-day myocardial infarction

    90 days

  • The rate of 90-day systemic embolism

    90 days

  • The rate of 90-day major extracranial hemorrhage

    90 days

  • +4 more secondary outcomes

Study Arms (2)

Anticoagulation alone

ACTIVE COMPARATOR

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

Drug: Anticoagulant Oral

Anticoagulation combined with antiplatelet therapy

EXPERIMENTAL

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

Drug: Anticoagulation combined with antiplatelet therapy

Interventions

Anticoagulant OralDRUG

Anticoagulation alone

Anticoagulation alone
Anticoagulation combined with antiplatelet therapyDRUG

Anticoagulation combined with antiplatelet therapy

Anticoagulation combined with antiplatelet therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, China

RECRUITING

Jiaxing Second Hospital

Jiaxing, China

RECRUITING

MeSH Terms

Conditions

Ischemic StrokeAtrial FibrillationCarotid StenosisIntracranial Arteriosclerosis

Interventions

Anticoagulants

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesArrhythmias, CardiacHeart DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCarotid Artery DiseasesArterial Occlusive DiseasesIntracranial Arterial DiseasesArteriosclerosis

Intervention Hierarchy (Ancestors)

Hematologic AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Central Study Contacts

Min Lou, PhD

CONTACT

+8613958007213loumingxc@vip.sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2023

First Posted

September 28, 2023

Study Start

September 29, 2023

Primary Completion

October 1, 2025

Study Completion

January 1, 2026

Last Updated

March 18, 2024

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)