Trial · NCT07900503
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With at Least One Adverse Event | From the first dose through Day 90 (plus or minus 7 days) | Percentage of participants in the safety analysis set who experience at least one adverse event after the first dose of study product through the final follow-up visit. An adverse event is an unfavorable medical occurrence regardless of its causal relationship to the study product. The safety analysis set includes randomized participants who receive at least one dose. Event severity and relationship to the study product will also be summarized, and incidence will be compared between groups. |
| Primary | Percentage of Participants With at Least One Study Product-Related Adverse Reaction | From the first dose through Day 90 (plus or minus 7 days). | Percentage of participants in the safety analysis set who experience at least one adverse reaction judged by the investigator to be related to the study product, from the first dose through the final follow-up visit. Causality is assessed using the protocol categories of not related, probably not related, possible, probable, and definite. Incidence will be compared between groups. |
| Primary | Percentage of Participants With at Least One Serious Adverse Event | From the first dose through Day 90 (plus or minus 7 days). | Percentage of participants in the safety analysis set who experience at least one serious adverse event from the first dose through the final follow-up visit. Serious adverse events include death, life-threatening events, hospitalization or prolonged hospitalization, persistent disability or loss of function, congenital anomalies, or other medically important events. Incidence will be compared between groups regardless of causality. |
| Secondary | Change From Baseline in National Institutes of Health Stroke Scale Score | Baseline and Days 7 and 14 (plus or minus 2 days for Day 14). | Change in NIHSS total score from the pre-intervention baseline to each follow-up assessment, compared between groups. NIHSS scores range from 0 to 42, with higher scores indicating greater neurological impairment. Change is calculated as the follow-up score minus the baseline score; a negative change indicates improvement. Baseline assessment is performed at screening before study product administration. |
| Secondary | Change From Baseline in Modified Rankin Scale Score | Pre-dose baseline and Day 90 (plus or minus 7 days). | Change in modified Rankin Scale (mRS) score from the pre-dose baseline at Visit 2 to the final follow-up, compared between groups. The mRS ranges from 0 (no symptoms) to 6 (death), with higher scores indicating a worse outcome. Change is calculated as the follow-up score minus the baseline score; negative, zero, and positive changes indicate improvement, no change, and worsening, respectively. Assessment may be conducted by telephone if an in-person visit is not possible. |
| Secondary | Change From Baseline in Barthel Index Score | Pre-dose baseline and Day 90 (plus or minus 7 days). | Change in Barthel Index score from the pre-dose baseline at Visit 2 to the final follow-up, compared between groups. The index assesses independence in activities of daily living, with higher scores indicating greater independence. Change is calculated as the follow-up score minus the baseline score; positive, zero, and negative changes indicate improvement, no change, and worsening, respectively. Assessment may be conducted by telephone if an in-person visit is not possible. |
| Secondary | Hospital Length of Stay | Through Day 90 (plus or minus 7 days); reviewed at Days 7, 14, and 90. | Number of days spent in hospital during the study observation period, compared between groups. Hospital stays and reasons for readmission will be recorded at follow-up visits. |
| Secondary | Intensive Care Unit Length of Stay | Through Day 90 (plus or minus 7 days); reviewed at Days 7, 14, and 90. | Number of days spent in an intensive care unit during the study observation period, compared between groups. Intensive care admissions and their reasons will be recorded at follow-up visits. |
| Secondary | Change From Baseline in Interleukin-6 Concentration | Pre-dose baseline and Days 7 and 14 (plus or minus 2 days for Day 14). | Change in blood interleukin-6 (IL-6) concentration from the pre-dose baseline to each follow-up assessment, compared between groups. Change is calculated as the follow-up concentration minus the baseline concentration. Samples will be analyzed by the National Research Institute of Chinese Medicine. |
| Secondary | Change From Baseline in Tumor Necrosis Factor-alpha Concentration | Pre-dose baseline and Days 7 and 14 (plus or minus 2 days for Day 14). | Change in blood tumor necrosis factor-alpha (TNF-alpha) concentration from the pre-dose baseline to each follow-up assessment, compared between groups. Change is calculated as the follow-up concentration minus the baseline concentration. Samples will be analyzed by the National Research Institute of Chinese Medicine. |
| Secondary | Change From Baseline of Pre-dose baseline and Days 7 and 14 (plus or minus 2 days for Day 14). | Pre-dose baseline and Days 7 and 14 (plus or minus 2 days for Day 14). | Change in Pre-dose baseline and Days 7 and 14 (plus or minus 2 days for Day 14). from the pre-dose baseline to each follow-up assessment, compared between groups. Change is calculated as the follow-up value minus the baseline value. |
| Secondary | Change From Baseline in Prothrombin Time | Pre-dose baseline and Days 7 and 14 (plus or minus 2 days for Day 14). | Change in prothrombin time (PT) from the pre-dose baseline to each follow-up assessment, compared between groups. Change is calculated as the follow-up value minus the baseline value. |
| Secondary | Change From Baseline in Activated Partial Thromboplastin Time | Pre-dose baseline and Days 7 and 14 (plus or minus 2 days for Day 14). | Change in activated partial thromboplastin time (aPTT) from the pre-dose baseline to each follow-up assessment, compared between groups. Change is calculated as the follow-up value minus the baseline value. |
| Secondary | Change From Baseline in International Normalized Ratio | Pre-dose baseline and Days 7 and 14 (plus or minus 2 days for Day 14). | Change in prothrombin time international normalized ratio (INR), a dimensionless measure, from the pre-dose baseline to each follow-up assessment, compared between groups. Change is calculated as the follow-up value minus the baseline value. |
| Secondary | Change From Baseline in Alanine Aminotransferase | Pre-dose baseline and Days 7 and 14 (plus or minus 2 days for Day 14). | Change in alanine aminotransferase (ALT) from the pre-dose baseline to each follow-up assessment, compared between groups. Change is calculated as the follow-up value minus the baseline value. |
| Secondary | Change From Baseline in Aspartate Aminotransferase | Change in aspartate aminotransferase (AST) from | Pre-dose baseline and Days 7 and 14 (plus or minus 2 days for Day 14). | Change in aspartate aminotransferase (AST) from the pre-dose baseline to each follow-up assessment, compared between groups. Change is calculated as the follow-up value minus the baseline value. |
| Secondary | Change From Baseline in Blood Urea Nitrogen | Pre-dose baseline and Days 7 and 14 (plus or minus 2 days for Day 14). | Change in blood urea nitrogen (BUN) from the pre-dose baseline to each follow-up assessment, compared between groups. Change is calculated as the follow-up value minus the baseline value. |
| Secondary | Change From Baseline in Creatinine | Pre-dose baseline and Days 7 and 14 (plus or minus 2 days for Day 14). | Change in creatinine from the pre-dose baseline to each follow-up assessment, compared between groups. Change is calculated as the follow-up value minus the baseline value. |
| Secondary | Change From Baseline in Blood Glucose | Pre-dose baseline and Days 7 and 14 (plus or minus 2 days for Day 14). | Change in blood glucose from the pre-dose baseline to each follow-up assessment, compared between groups. Change is calculated as the follow-up value minus the baseline value. |
| Other | Percentage of Participants With Hemorrhagic Transformation | From the first dose through Day 90 (plus or minus 7 days). | Percentage of participants with imaging-confirmed hemorrhagic transformation during follow-up. |
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.
For software
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