NCT06057467

Brief Summary

The goal of this clinical trial is to compare the effectiveness between early and late initiation of anticoagulation therapy in acute ischemic stroke (AIS) patients with non-valvular atrial fibrillation (NVAF). Participants will be 1:1 randomized into early or late initiation group. The primary endpoint is early neurological deterioration (END) before discharge.

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
2,351

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

September 15, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 28, 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 13, 2023

Last Update Submit

March 15, 2024

Conditions

Acute Ischemic StrokeAtrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Early neurological deterioration before discharge

    NIHSS at discharge increase at least 2 points compared with NIHSS on admission

    At discharge, an average of 7 days

Secondary Outcomes (10)

  • 90-day Composite events

    90 days

  • 90-day ischemic stroke

    90 days

  • 90-day hemorrhagic stroke

    90 days

  • 90-day myocardial infarction

    90 days

  • 90-day systemic embolism

    90 days

  • +5 more secondary outcomes

Study Arms (2)

Early initiation of anticoagulation

EXPERIMENTAL

For patients with NIHSS 0-3, anticoagulation therapy will be initiated within 0-3 days of onset. For patients with NIHSS 4-8, anticoagulation therapy will be initiated within 4-6 days of onset.

Drug: Anticoagulation Agents

Late initiation of anticoagulation

ACTIVE COMPARATOR

For patients with NIHSS 0-3, anticoagulation therapy will be initiated within 4-12 days of onset. For patients with NIHSS 4-8, anticoagulation therapy will be initiated within 7-12 days of onset.

Drug: Anticoagulation Agents

Interventions

Anticoagulation AgentsDRUG

Anticoagulation agents includes rivaroxaban, dabigatran, apixaban, and edoxaban.

Early initiation of anticoagulationLate initiation of anticoagulation

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 with onset \< 48 hours
  • Have a history or newly diagnosed as NVAF
  • NIHSS on admission \<= 8

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 therapy within 12 days after AIS, e.g. severe intracranial hemorrhage
  • Received reperfusion therapy, e.g. intravenous thrombolysis and endovascular treatment
  • Concomitant stenosis (\>50%) of carotid artery/intracranial artery, of which the ischemic lesion located within the territory
  • 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 Fibrillation

Interventions

Anticoagulants

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesArrhythmias, CardiacHeart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

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 13, 2023

First Posted

September 28, 2023

Study Start

September 15, 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)