Acute Ischemic Stroke, Stroke
Conditions
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.
Interventions
DRUGRivaroxaban, 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
DRUGAspirin
Aspirin 100mg once daily, or alternatives (Clopidogrel 75mg once daily, Ticagrelor 90mg twice daily, Cilostazol 100mg twice daily) if aspirin is unsuitable
Sponsors
Second Affiliated Hospital, Zhejiang University, School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: 1. Cortical or multi-territorial infarct 2. Recurrent stroke or stroke on antiplatelet therapy 3. Left atrial diameter \>40 mm 4. Left ventricular dysfunction (EF 30-40% or regional wall motion abnormality) 5. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-month ischemic stroke recurrence | 90 ± 7 days | Recurrent ischemic stroke within 3 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-month Composite vascular event | 90 ± 7 days | Composite of ischemic stroke, hemorrhagic stroke, myocardial infarction, major extracranial bleeding, and vascular death within 3 months |
| Presence of intracerebral hemorrhage (ICH) evaluated by CT or MRI | 90 ± 7 days | the presence of ICH is defined according the standard from ECASS-2 study |
| Presence of myocardial infarction within 3 months | 90 ± 7 days | Presence of myocardial infarction within 3 months |
| Presence of major extracranial bleeding within 3 months | 90 ± 7 days | Presence of major extracranial bleeding within 3 months |
| Presence of vascular death within 3 months | 90 ± 7 days | Hospitalization records or follow-up results |
| 3-month mortality | 90 ± 7 days | Hospitalization records or follow-up results |
Contacts
CONTACTMin Lou, PhD, MD
CONTACTKemeng Zhang, MD
PRINCIPAL_INVESTIGATORMin Lou, PhD, MD
Second Affiliated Hospital, Zhejiang University, School of Medicine
Outcome results
None listed