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NCT Number: NCT07746882

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivaroxaban, or Edoxaban , or Apixaban , or Dabigatran

Drug

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

Other names: Anticoagulation Therapy

Aspirin

Drug

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

Other names: Anti-platelet therapy

Primary outcomes

  1. 3-month ischemic stroke recurrence

    Time frame: 90 ± 7 days

    Recurrent ischemic stroke within 3 months.

Secondary outcomes

  1. 3-month Composite vascular event

    Time frame: 90 ± 7 days

    Composite of ischemic stroke, hemorrhagic stroke, myocardial infarction, major extracranial bleeding, and vascular death within 3 months

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

    Time frame: 90 ± 7 days

    the presence of ICH is defined according the standard from ECASS-2 study

  3. Presence of myocardial infarction within 3 months

    Time frame: 90 ± 7 days

    Presence of myocardial infarction within 3 months

  4. Presence of major extracranial bleeding within 3 months

    Time frame: 90 ± 7 days

    Presence of major extracranial bleeding within 3 months

  5. Presence of vascular death within 3 months

    Time frame: 90 ± 7 days

    Hospitalization records or follow-up results

  6. 3-month mortality

    Time frame: 90 ± 7 days

    Hospitalization records or follow-up results

Study contacts

Contact information is provided by the study sponsor or research team.

Kemeng Zhang, MD

CONTACT

[email protected]

8617816860685

Min Lou, PhD, MD

CONTACT

[email protected]

8613958007213

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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