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Trial · NCT07882030

Registered outcomes13

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

ListOutcomeTime frameDescription
PrimaryFunctional Independence at 90 Days90 ± 7 days after randomization
The proportion of participants achieving functional independence at 90 days after randomization, defined as a modified Rankin Scale (mRS) score of 0 to 2. The mRS ranges from 0 to 6, with higher scores indicating greater disability.
SecondaryExcellent Functional Outcome at 90 Days90 ± 7 days after randomizationThe proportion of participants achieving an excellent functional outcome at 90 days after randomization, defined as a modified Rankin Scale (mRS) score of 0 to 1.
SecondaryDistribution of Modified Rankin Scale Scores at 90 Days90 ± 7 days after randomizationThe distribution of modified Rankin Scale (mRS) scores from 0 to 6 at 90 days after randomization. Higher scores indicate greater disability.
SecondaryChange in Barthel Index From Baseline to Day 90Baseline to 90 ± 7 days after randomizationThe change in Barthel Index score from baseline to 90 days after randomization.
SecondaryChange in NIHSS Score From Baseline to Day 14Baseline to day 14 ± 3 after randomization
The change in National Institutes of Health Stroke Scale (NIHSS) score from baseline to day 14 after randomization. The NIHSS ranges from 0 to 42, with higher scores indicating greater neurological impairment.
SecondaryNeurological Improvement at Day 14Day 14 ± 3 after randomizationThe proportion of participants with neurological improvement at day 14 after randomization, defined as a reduction in NIHSS score of at least 4 points from baseline.
SecondaryChange in NIHSS Score From Baseline to Day 7Baseline to day 7 after randomization
The change in National Institutes of Health Stroke Scale (NIHSS) score from baseline to day 7 after randomization.The total NIHSS score ranges from 0 to 42, where higher scores represent greater neurological impairment (worse outcome). A decrease in score indicates improvement.
SecondarySymptomatic Intracranial Hemorrhage Within 7 DaysWithin 7 days after randomization
The proportion of participants experiencing symptomatic intracranial hemorrhage within 7 days after randomization, defined according to the European Cooperative Acute Stroke Study III (ECASS III) criteria.
OtherSerious Adverse Events Within 90 DaysFrom randomization through day 90 ± 7The proportion of participants experiencing at least one serious adverse event from randomization through day 90.
OtherAll-Cause Mortality Within 90 DaysWithin 90 ± 7 days after randomizationThe proportion of participants who die from any cause within 90 days after randomization.
OtherChange in Serum Alanine Aminotransferase From Baseline to Day 7Baseline to day 7 after randomizationThe change in serum alanine aminotransferase (ALT) concentration from baseline to day 7 after randomization.
OtherChange in Serum Aspartate Aminotransferase From Baseline to Day 7Baseline to day 7 after randomizationThe change in serum aspartate aminotransferase (AST) concentration from baseline to day 7 after randomization.
OtherChange in Creatinine Clearance From Baseline to Day 7Baseline to day 7 after randomizationThe change in creatinine clearance from baseline to day 7 after randomization.

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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