NCT07746882

Brief Summary

To screen ischemic stroke patients likely to benefit from anticoagulation and compare the effectiveness and safety of anticoagulation versus antiplatelet therapy in preventing recurrent ischemic stroke within 3 months.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
680

participants targeted

Target at P50-P75 for phase_3 stroke

Timeline
28mo left

Started Aug 2026

Shorter than P25 for phase_3 stroke

Status
not yet recruiting

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

July 31, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 5, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

August 15, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2028

Last Updated

August 5, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

July 31, 2026

Last Update Submit

August 4, 2026

Conditions

StrokeAcute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • 3-month ischemic stroke recurrence

    Recurrent ischemic stroke within 3 months.

    90 ± 7 days

Secondary Outcomes (6)

  • 3-month Composite vascular event

    90 ± 7 days

  • Presence of intracerebral hemorrhage (ICH) evaluated by CT or MRI

    90 ± 7 days

  • Presence of myocardial infarction within 3 months

    90 ± 7 days

  • Presence of major extracranial bleeding within 3 months

    90 ± 7 days

  • Presence of vascular death within 3 months

    90 ± 7 days

  • +1 more secondary outcomes

Study Arms (2)

Anticoagulation Group

EXPERIMENTAL

Rivaroxaban 15mg once daily, or Edoxaban 30mg once daily, or Apixaban 2.5mg twice daily, or Dabigatran 110mg twice daily

Drug: Rivaroxaban, or Edoxaban , or Apixaban , or Dabigatran

Anti-platelet Group

OTHER

Aspirin 100mg once daily, or alternatives (Clopidogrel 75mg once daily, Ticagrelor 90mg twice daily, Cilostazol 100mg twice daily) if aspirin is unsuitable

Drug: Aspirin

Interventions

Rivaroxaban, or Edoxaban , or Apixaban , or DabigatranDRUG

Rivaroxaban 15mg once daily, or Edoxaban 30mg once daily, or Apixaban 2.5mg twice daily, or Dabigatran 110mg twice daily

Also known as: Anticoagulation Therapy
Anticoagulation Group
AspirinDRUG

Aspirin 100mg once daily, or alternatives (Clopidogrel 75mg once daily, Ticagrelor 90mg twice daily, Cilostazol 100mg twice daily) if aspirin is unsuitable

Also known as: Anti-platelet therapy
Anti-platelet Group

Eligibility Criteria

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

You may qualify if:

  • Age ≥18 years
  • Ischemic stroke patients with undetermined etiology, within 14 days of onset, with completed etiological assessment
  • At least one of the following:
  • Cortical or multi-territorial infarct
  • Recurrent stroke or stroke on antiplatelet therapy
  • Left atrial diameter \>40 mm
  • Left ventricular dysfunction (EF 30-40% or regional wall motion abnormality)
  • Atrial premature beats \>1500/24h

You may not qualify if:

  • Stenosis ≥50% in the responsible vessel or high-risk plaque
  • Identified cardioembolic source
  • PFO with planned closure
  • Malignancy
  • Indication for mandatory anticoagulation/antiplatelet therapy
  • Active bleeding (intracranial, subarachnoid, gastrointestinal, etc.)
  • History of intracranial hemorrhage
  • Current or recent gastrointestinal ulcer
  • Recent brain or spinal injury/surgery
  • Known or suspected vascular malformations or aneurysms
  • Severe renal impairment (CrCl \<30 ml/min)
  • Liver disease with bleeding risk (Child-Pugh B or C)
  • Pregnancy or lactation
  • Other contraindications to anticoagulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

StrokeIschemic Stroke

Interventions

RivaroxabanedoxabanapixabanDabigatranAnticoagulation BridgeAspirinDual Anti-Platelet Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyridinesBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingBridge TherapyTherapeuticsSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsDrug Therapy, CombinationDrug Therapy

Study Officials

  • Min Lou, PhD, MD

    Second Affiliated Hospital, Zhejiang University, School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Lou, PhD, MD

CONTACT

8613958007213lm99@zju.edu.cn

Kemeng Zhang, MD

CONTACT

8617816860685lm99@zju.edu.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2026

First Posted

August 5, 2026

Study Start (Estimated)

August 15, 2026

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

November 30, 2028

Last Updated

August 5, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Protecting the privacy of participants is a priority, and sharing IPD could potentially compromise this.