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Trial · NCT03735979

Registered outcomes13

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

ListOutcomeTime frameDescription
Primary90-day Utility Weighted Modified Rankin Scores (UW-mRS)90 days after randomization
The modified Rankin scale is a 7 point ordinal scale ranging from 0="no symptoms" to 6="death" . For the primary analysis, the scale was analyzed with patient-centered utility weights. We assigned the following utility weights to the seven levels: 10, 9.1,, 7.6, 6.5, 3.3, 0, 0 (with higher scores indicating a better outcome).
SecondaryPercentage of Participants With NIHSS Less Than or Equal to 2 at 24 Hours24 hours after randomization
National Institute of Health Stroke Scale (NIHSS) scores range from 0 to 42, with higher scores indicating worse neurologic deficit. This is a dichotomous analysis with a cutpoint of 0,1,2 defining the event.
SecondaryChange From Baseline to 24-hour NIHSS24 hours after randomizationNational Institute of Health Stroke Scale (NIHSS) scores range from 0 to 42, with higher scores indicating worse neurologic deficit.
SecondaryPercentage of Participants With 90-day mRS 0 or 1 (or Return to Their Historical mRS)90 days after randomization
The modified Rankin scale (mRS) is a 7 point scale ranging from 0="no symptoms" to 6="death" where lower scores are better outcomes. For patients with a pre-stroke mRS of greater than 0 or 1, these patients had to return to their historical (pre-stroke) value to be counted as a success.
SecondaryPercentage of Participants With 90-day mRS 0, 1 or 2 (or Return to Their Historical mRS)90 days after randomizationmodified Rankin scale is a 7 point scale ranging from 0="no symptoms" to 6="death" where lower scores are better outcomes.
Secondary90-day mRS90 days after randomizationmodified Rankin scale is a 7 point ordinal scale ranging from 0="no symptoms at all" to 6="death" where lower scores are better outcomes.
Secondary90-day EQ-5D90 days after randomizationEuroQol Five-Dimension (EQ-5D) is a measure of health-related quality of life ranging from -0.59 to 1 where 1 is the best possible health state.
SecondaryPre-thrombectomy Modified TICI Score of 2B.baseline
The modified thrombolysis in cerebral infarction (TICI) score prior to endovascular thrombectomy procedure. The modified pre-thrombectomy TICI score is a 4 point scale with possible values of 0, 1, 2A, and 2B. The values are defined as follows: 0=No flow, 1=Penetration without distal branch filling, 2A=\<50% partial reperfusion, and 2B=50%-99% partial reperfusion.
SecondaryPost-thrombectomy Modified TICI Score of 2B or 3baseline
The modified thrombolysis in cerebral infarction (TICI) score prior to endovascular thrombectomy procedure. The modified post-thrombectomy TICI score is a 5 point scale with possible values of 0, 1, 2A, 2B, 3. The values are defined as follows: 0=No flow, 1=Penetration without distal branch filling, 2A=\<50% partial reperfusion, 2B=50%-99% partial reperfusion, and 3=Completed reperfusion
OtherSymptomatic Intracranial Hemorrhage Within 36 Hours (Primary Safety Outcome)36 hours after randomization
Type 2 parenchymal hemorrhage or a parenchymal hemorrhage remote from the area of infarction with neurologic deterioration (defined as an increase of ≥4 points in the NIHSS score)within 36 hours after randomization.
OtherType 1 or Type 2 Parenchymal Hemorrhage Within 36 Hours (Safety Outcome)36 hours after randomization
OtherAny Intracranial Hemorrhage Within 36 Hours (Safety Outcome)36 hours after randomizationSymptomatic or asymptomatic intracranial hemorrhage within 36 hours of randomization.
OtherOther Major Hemorrhage Other Than Intracranial Hemorrhage Within 7 Days (Safety Outcome)7 days after randomizationOther major hemorrhage other than intracranial hemorrhage (resulting in the transfusion of \>2 units of packed red cells).

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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