Trial · NCT07906275
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | A change of functional dependence analyzed across the whole distribution of outcomes assessed on the modified Rankin Scale (mRS), | From enrollment to the Day 90 assessment - Day 90 outcomes are assessed in a blinded manner | Modified Rankin Scale (mRS) -which scores of 0 to 1 indicate a favourable outcome without or with symptoms but no disability, scores of 2 to 5 indicate increasing levels of disability (and dependency), and a score of 6 indicates death. |
| Secondary | Ordinal Modified Rankin Score at 30 days | telephone called performed by a " blinded assessor" between 23-37 days after randomization | Modified Rankin Scale (mRS) -which scores of 0 to 1 indicate a favourable outcome without or with symptoms but no disability, scores of 2 to 5 indicate increasing levels of disability (and dependency), and a score of 6 indicates death. |
| Secondary | 24-hour National Institute of Stroke Scale Score (NIHSS) | From enrollment (randomization ) to 18-56 hours (Day 2) | The National Institutes of Health Stroke Scale (NIHSS) is a standardized clinical assessment used by trained healthcare professionals to measure the severity of neurological impairment caused by a stroke.It evaluates 11 areas, including level of consciousness, gaze, visual fields, facial movement, arm and leg strength, coordination, sensation, language, speech and neglect. Scores range from 0 to 42, with higher scores indicating greater neurological impairment. The NIHSS is used during the initial assessment and subsequent reassessments to document changes in neurological status and support treatment and clinical decision-making. |
| Secondary | Difference between 24 hour and baseline National Institute of Stroke Scale Score (NIHSS) | From enrollment (randomization) to 18-56 hours (Day 2) | The National Institutes of Health Stroke Scale (NIHSS) is a standardized clinical assessment used by trained healthcare professionals to measure the severity of neurological impairment caused by a stroke.It evaluates 11 areas, including level of consciousness, gaze, visual fields, facial movement, arm and leg strength, coordination, sensation, language, speech and neglect. Scores range from 0 to 42, with higher scores indicating greater neurological impairment. The NIHSS is used during the initial assessment and subsequent reassessments to document changes in neurological status and support treatment and clinical decision-making. |
| Secondary | Final reperfusion quality (extended Thrombolysis in Cerebral Infarction (MeVO eTICI) scale) | From enrollment (randomization) to post EVT procedure. Completed by the Central Core lab at 30 days after randomization | The thrombolysis in cerebral infarction (TICI) grading system as a tool for determining the response of thrombolytic therapy for ischemic stroke. In neurointerventional radiology it is commonly used for patients post endovascular revascularization. |
| Secondary | Infarct volume on 18-56-hour scan | Completed by the Central Core lab at 30 days after randomization | The thrombolysis in cerebral infarction (TICI) grading system as a tool for determining the response of thrombolytic therapy for ischemic stroke. In neurointerventional radiology it is commonly used for patients post endovascular revascularization. |
| Secondary | The proportion of patients with Symptomatic intracranial hemorrhage from enrolment up to Day 4 | From enrollment ( randomization) to Day 4 | Serious Adverse events include the following events :results in death, life threatening,Requires inpatient hospitalization or prolongation of existing hospitalization,Results in persistent disability/incapacity,Is a congenital anomaly/birth defect, an important medical event that may not result in death, be life-threatening, or require hospitalization, but may jeopardize the participant and may require medical or surgical intervention to prevent an outcome listed in the SAE selection. |
| Secondary | Parenchymal hemorrhage (PH-1 and PH-2) | From enrollment ( randomization) to Day 4 | PH-1-2:( hemorrhage grading scale) homogeneous hyperdensity occupying over 30% of the infarct zone, with significant mass effect |
| Secondary | Safety Assessments of Serious Adverse Events (SAEs) from enrollment up to Day 4 | From enrollment ( randomization) to Day 4 | Serious Adverse events include the following events :results in death, life threatening,Requires inpatient hospitalization or prolongation of existing hospitalization,Results in persistent disability/incapacity,Is a congenital anomaly/birth defect, an important medical event that may not result in death, be life-threatening, or require hospitalization, but may jeopardize the participant and may require medical or surgical intervention to prevent an outcome listed in the SAE selection. |
| Secondary | The Ordinal shift of 7 levels of mRS at 90 days (mRS 5 and 6 will be collapsed in one category) | Done by telephone at the Day 90 assessment (Day 90 outcomes are assessed in a blinded manner) | Modified Rankin Scale (mRS) -which scores of 0 to 1 indicate a favourable outcome without or with symptoms but no disability, scores of 2 to 5 indicate increasing levels of disability (and dependency), and a score of 6 indicates death. |
| Secondary | Ambulatory status of the patient's mobility at discharge | Completed at Day discharge or Day 4 or from randomization. | Assessing mobility of the patient at discharge- these are the questions that are asked: If alive, can the subject walk 10 steps without assistance? (Without assistance from another person. The use of a walking aid is acceptable- yes or no. |
| Secondary | Name and location of the Place of residence at 90 days | Completed at the Day 90 assessment. | Assessing the patient's residence at the Day 90 follow up. the information being collected is: What is the subject's place of residence at final contact? (-home, acute care hospital, repatriation to secondary hospital, inpatient rehabilitation care hospital, care facility, deceased or unknown) |
| Secondary | Summative total length of hospital stay in the first 90-days after stroke onset | Completed at the Day 90 assessment. | Calculating the total number of days the patient was hospitalized since their hospital admission. |
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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