Glenzocimab for REperfusion in the Setting of Endovascular Therapy for Brain infarctioN: GREEN Study
Trial · NCT05559398
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy mRS 90 | 90 days | The primary efficacy endpoint is the functional outcome assessed by the modified Rankin Scale (mRS) at day 90 +/- 15 days. The Modified Rankin Scale (mRS) is used to measure the degree of disability in patients who have had a stroke. The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead. |
| Secondary | Favorable functional outcome | 90 days | Favorable functional outcome defined by a mRS ≤ 2 at day 90 +/- 15 days |
| Secondary | Severe handicap | 90 days | Proportion of patients with a severe handicap: mRS equal to 4, 5 or 6 at day 90 +/- 15 days |
| Secondary | Survival | 90 days and 1 year | Overall survival at 90 days and 1 year |
| Secondary | Early reperfusion outcomes : volume | 24 hours | Stroke volume by MRI at 24 hrs |
| Secondary | Early reperfusion outcomes : eTICI | 24 hours | Reperfusion at the end of procedure assessed by the expanded treatment in cerebral infarction (eTICI) score.The eTICI is defined as follows : grade 0: no perfusion noted (0% reperfusion) grade 1: reduction in thrombus but without any resultant filling of distal arterial branches grade 2a: reperfusion of 1-49% of the territory grade 2b50: reperfusion of 50-66% of the territory grade 2b67: reperfusion of 67-89% of the territory grade 2c: extensive reperfusion of 90-99% of the territory grade 3: complete or full reperfusion (100% reperfusion) |
| Secondary | Early reperfusion outcomes NIHSS | 24 hours | Early neurological improvement by National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) at 24 hrs. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0. |
| Secondary | Quality of life | 90 days and 1 year | EQ5D-5L at day 90 and at 1 year. EQ-5D is a standardised measure of health-related quality of life. The EQ-5D-5L descriptive system uses five dimensions. The five levels in each dimension are worded as (1) 'not /no problems', (2) 'slight problems', (3) 'moderate problems', (4) 'severe problems', and (5) 'unable to' (mobility, self-care, usual activities), 'extreme' (pain/depression), or 'extremely' (anxiety/depression). EQ-5D-5L is the sum of the five dimensions. |
| Secondary | IntraCranial Hemorrhages | 24 hours | Incidence of symptomatic or non-symptomatic IntraCranial Hemorrhages (ICH) at 24 hrs |
| Secondary | Symptomatic IntraCranial Hemorrhages | 24 hours | Incidence of symptomatic IntraCranial Hemorrhages (ICH) at 24 hrs |
| Secondary | Non-Symptomatic IntraCranial Hemorrhages | 24 hours | Incidence of non-symptomatic IntraCranial Hemorrhages (ICH) at 24 hrs |
| Secondary | Adverse event | 24 hours, 7 days, 30 days, 90 days | Incidence, nature and severity of Adverse Events, SAEs, SUSARs, Bleeding-Related Events (BREs) and/or Treatment-Emergent Adverse Events (TEAEs), at 24 hrs, at D7/discharge, 30 days and 90 days |
| Secondary | Bleeding relating events | 90 days | Incidence of bleeding-related events at 90 days |
| Secondary | Anti-glenzocimab antibodies | 3 months | Anti-glenzocimab antibodies (ADA) blood concentration at 3 months for 50 patients. |
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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