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Trial · NCT06319846

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryAny new ischemic stroke at 3-monthat 3-monthIncidence of any new ischemic stroke at 3-month
PrimaryType 3 or 5 bleeding events according to the BARC criteria at 3-monthat 3-monthIncidence of type 3 or 5 bleeding events according to the BARC criteria at 3-month
SecondaryAny new ischemic stroke within 1 yearwithin 1 yearIncidence of any new ischemic stroke within 1 year
SecondaryNew clinical vascular events (ischemic stroke/ hemorrhagic stroke/ TIA/ myocardial infarction/vascular death) within 3 months and 1 year; Each new vascular event will be independently evaluated.Within 3 months after randomization and 1 year
Incidence of new clinical vascular events (ischemic stroke/ hemorrhagic stroke/ TIA/ myocardial infarction/vascular death) within 3 months and 1 year; Each new vascular event will be independently evaluated.
SecondaryDisabling stroke (Modified Rankin Scale score, mRS>1) at 3 months and 1 yearat 3 months and 1 yearProportion of patients with disabling stroke (Modified Rankin Scale score, mRS\>1) at 3 months and 1 year. Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death).
SecondaryIncidence and severity of recurrent stroke and TIAWithin 3 months after randomization and 1 year
Incidence and severity of recurrent stroke and TIA during follow-up to 3 months and 1-year (Severity is measured using a six-level ordered categorical scale that incorporates the mRS: fatal stroke/severe non-fatal stroke \[mRS 4 or 5\]/moderate stroke \[mRS 2 or 3\]/mild stroke \[mRS 0 or 1\]/TIA/no stroke-TIA)
SecondaryNeurological impairment at 3 months (NIHSS increased≥4 from baseline ).at 3 monthsProportion of patients with neurological impairment at 3 months ( National Institutes of Health Stroke Scale \[NIHSS\] score increased≥4 from baseline).
OtherType 3 or 5 bleeding events (BARC definition) at 1 yearat 1 yearProportion of patients with type 3 or 5 bleeding events (BARC definition) at 1 year.
OtherType 2, 3 or 5 bleeding events according to the BARC criteria at 3-month and 1-year.at 3-month and 1-yearProportion of patients with type 2, 3 or 5 bleeding events according to the BARC criteria at 3-month and 1-year.
OtherAll bleeding events (type 1-5 bleeding events according to the BARC criteria)at 3-month and 1-yearAll bleeding events (type 1-5 bleeding events according to the BARC criteria) at 3-month and 1-year; Each bleeding event will be independently evaluated
OtherTotal mortality at 3-month and 1-yearat 3-month and 1-yearProportion of patients with total mortality at 3-month and 1-year
OtherAdverse events/Severe adverse events reported by investigators at 3-month and 1-yearat 3-month and 1-year

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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