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Trial · NCT05070260

Registered outcomes77

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

ListOutcomeTime frameDescription
PrimaryBinary Poor Outcome on the mRS defined by a score of 4-6 (versions 0-3)Day 90To show the efficacy of glenzocimab vs. placebo, on the "poor outcome" defined as a mRS score of 4-6 (vs 0-3) assessed at Day 90
SecondaryKey Secondary Efficacy Endpoint - mRSDay 90Binary "Favorable Outcome" on the mRS defined by a score of 0-2 (versus 3-6)
SecondaryMortalityDay 90All cause mortality
SecondarymRSDay 90To assess the favorable responses defined as mRS score of 0-1
SecondarymRSDay 90To assess the favorable responses defined as mRS score of 5-6
SecondaryOrdinal mRSDay 90To assess the shift analysis
SecondaryUtility Weighted mRSDay 90To assess the utility weighted mRS (UW-mRS)
SecondaryAll cause mortality72 hoursTo assess all cause mortality
SecondaryICHs72 hoursSymptomatic and non-symptomatic ICHs
SecondaryNeurological Status Change as assessed by NIHSS value compared to pre-IVT value24 hoursResponse defined by a relative decrease (%) in NIHSS value at 24 hours compared to pre-IVT value higher than 30%. Relative change (%) in NIHSS value at 24 hrs compared to pre-IVT value
SecondaryRecanalization rateDay 90To assess recanalization in patients undergoing thrombectomy by eTICI score
SecondaryCerebral tissue reperfusionDay 90To assess Cerebral tissue reperfusion
SecondaryInfarct volume progression and hemorrhagic transformation24 hrsTo assess the impact on follow up imaging (follow up infarct volume, infarct growth and volume of hemorrhagic transformation)
SecondaryMeasure of Quality of Life by EuroQol-5 Dimension-5 Level (EQ-5D-5L)Day 90Quality of Life as assessed by the EuroQol-5 Dimension-5 Level. A Quality-of-Life Scale (EQ-5D-5L)
SecondaryIncidence of DeathsDay 90Deaths within the first 24 hours and over the whole study period until Day 90 (Kaplan-Meier curve)
SecondaryIncidence of Symptomatic intracranial hemorrhages24 hours
Symptomatic intracranial hemorrhages, defined by both anatomical imaging (according to Heidelberg's classification) at the time of its occurrence associated with an increase in NIHSS score by 4 points or greater, or death that is not explained otherwise (according to ECASS III study definition (14))
SecondaryIncidence of Non-symptomatic hemorrhages24 hoursNon-symptomatic hemorrhages, seen on 24-hours plain CT-Scan, not present at baseline assessment, once other diagnoses are excluded
SecondaryIncidence of Adverse Events, SAEs, bleeding-related events, and Treatment-Emergent Adverse Events (TEAEs)Day 90Incidence, nature and severity of Adverse Events, SAEs, bleeding-related events, and Treatment-Emergent Adverse Events (TEAEs)
SecondaryChange in vital signs (Blood Pressure) at any visit or discharge as compared to Baseline24 hoursBlood Pressure will be assessed every 30 minutes during the 6 hours (infusion) then every 3 hours up to 24 hours.
SecondaryChange in vital signs (Heart Rate) at any visit or discharge as compared to Baseline24 hoursHeart Rate will be assessed every 30 minutes during the 6 hours (infusion) then every 3 hours up to 24 hours

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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