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Not yet recruiting NCT07746882

Study on Anti-Thrombotic Regimens for Secondary Prevention in Ischemic Stroke Patients With Possible Benefit From Anticoagulation Therapy

Phase III Interventional Stroke Acute Ischemic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rivaroxaban, or Edoxaban , or Apixaban , or Dabigatran, Aspirin.
Who it may be relevant to
Registry conditions: Stroke, Acute Ischemic Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug Rivaroxaban, or Edoxaban , or Apixaban , or Dabigatran
    Rivaroxaban 15mg once daily, or Edoxaban 30mg once daily, or Apixaban 2.5mg twice daily, or Dabigatran 110mg twice daily
  • Drug Aspirin
    Aspirin 100mg once daily, or alternatives (Clopidogrel 75mg once daily, Ticagrelor 90mg twice daily, Cilostazol 100mg twice daily) if aspirin is unsuitable

Primary outcome measures

  • 3-month ischemic stroke recurrence [Time frame: 90 ± 7 days]
Secondary outcome measures (6)
  • 3-month Composite vascular event [Time frame: 90 ± 7 days]
  • Presence of intracerebral hemorrhage (ICH) evaluated by CT or MRI [Time frame: 90 ± 7 days]
  • Presence of myocardial infarction within 3 months [Time frame: 90 ± 7 days]
  • Presence of major extracranial bleeding within 3 months [Time frame: 90 ± 7 days]
  • Presence of vascular death within 3 months [Time frame: 90 ± 7 days]
  • 3-month mortality [Time frame: 90 ± 7 days]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07746882 · PACS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗