Stroke, AcutePhase 2/3GREENNCT05559398
Glenzocimab for REperfusion in the Setting of Endovascular Therapy for Brain infarctioN: GREEN Study
A Phase 2/3 study testing Glenzocimab in people with Stroke, Acute and Stroke, Ischemic, run by Assistance Publique - Hôpitaux de Paris at 12 sites in France.
Trial summary
Emergent reperfusion is the main goal for acute ischemic stroke therapy (AIS). Endovascular therapy (EVT) is recommended within 6 hrs of stroke onset, and up to 24 hrs following perfusion imaging criteria. Despite the major benefit associated with MT, more than 50% of the patients remain disabled at 3 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute, Stroke, Ischemic
- What is being tested?
- Glenzocimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 12 sitesFrance
- Study dates
- 3 Jan 2023to 30 Jul 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older (Age≥18 years)
- No significant pre-stroke disability (pre-stroke mRS must be equal to 0 or 1);
- Indication of EVT within the time-window of 0 to 24 hrs in participants treated with or without intravenous thrombolysis;
- Participants presenting with a target mismatch defined by an initial infarct volume (ischemic core) of less than 70 ml, a ratio of volume of ischemic tissue to initial infarct volume of 1.8 or more, and an absolute volume of potentially reversible ischemia (penumbra) of 15 ml or more on magnetic resonance imaging (MRI) or, when this is not possible, on perfusion computed tomography (CTP);
- Occlusion of the cervical or intracranial internal carotid artery (ICA) or the proximal middle cerebral artery (MCA - M1 and M2), on magnetic resonance angiography (MRA) or, when this is not possible, on CT angiography (CTA);
- Informed consent signed:
Show all 23Show fewer
- By the patient
- Or informed consent signed by a family members/trustworthy person if his condition does not allow him to express his consent by written as per L. 1111-6,
- In a situation urgently and in the absence of family members/trustworthy person, the patient can be enrolled. The consent to participate to the research will be requested as soon as the condition of the patient will allow him to consent.
- Post-menopausal women defined as not having menses for 12 months without an alternative medical cause. For WOCBP, a highly effective birth control method should be in place that can achieve a failure rate of less than 1% per year that should last for at least 2 months after IMP administration.
- Birth control methods which may be considered as highly effective in WOCBP include:
- combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (intravaginal, transdermal),
- progestogen-only hormonal contraception associated with inhibition of ovulation (injectable, implantable)
- intrauterine device (IUD),
- intrauterine hormone-releasing system (IUS),
- bilateral tubal occlusion,
- vasectomized partner,
- Birth control methods which may be considered as highly effective for men and that should last for 4 months after IMP administration include:
- vasectomy,
- use of condom combined with a highly effective birth control method for their WOCB partner.
- Please note that hormonal contraception is a risk factor for thromboembolic events and attention should be called to reconsider it passed the acute stroke phase.
- Women of child-bearing potential must have negative results of a plasma pregnancy test (serum betaHCG).
- Affiliation to social security or any health insurance
Who cannot join
- Contraindications to EVT;
- Contraindication to contrast agents
- Pre-existing neurologic and psychiatric disease with mRS ≥ 3;
- Unknown symptom's onset;
- Patients under or needing immediate DAPT administration;
- Patients previously treated by tenecteplase within 24 hrs;
Show all 19Show fewer
- Significant mass effect with midline shift as confirmed on CT/MRI;
- Gastrointestinal or urinary tract hemorrhage in previous 21 days;
- Patient with intracranial haemorrhage
- Platelet count <100 000 mm3;
- Pregnant or breastfeeding woman;
- Known hypersensitivity to glenzocimab or to any of the excipients;
- Severe renal insufficiency (Grades 4-5) with a glomerular filtration rate < 30mL/Min/1.73m2;
- Participation in another interventional clinical trial within 30 days prior to the inclusion.
- Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care under sections L.3212-1 et L.3213-1 and persons admitted to a health or social institution for purposes other than research (L.1121-6)
- Adults subject to a legal protection measure (L.1121-8)
- The patient or his/her family (if the patient is unable to give his/her opinion) expresses an inability to return for protocol visits
- patients receiving anticoagulants, as already mentioned in the non-authorized concomitant treatments
- patients who have already received another humanized fragment of monoclonal antibody with a suspicion of hypersensitivity
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Hospices Civils de Lyon
Bron
CHU Dupuytren
Limoges
CHU Timone
Marseille
Hôpital Gui de Chauliac
Montpellier
CHRU Nancy Hopital central
Nancy
Hôpital fondation Adolphe de Rothschild
Paris
Hôpital Lariboisière AP-HP
Paris
Hôpital Sainte Anne
Paris
Hôpital de Hautepierre
Strasbourg
Hôpital Foch
Suresnes
Hôpital Pierre Paul Riquet
Toulouse
CHRU Tours - Hôpital Bretonneau
Tours
About this study
Emergent reperfusion is the main goal for acute ischemic stroke therapy (AIS). Endovascular therapy (EVT) is recommended within 6 hrs of stroke onset, and up to 24 hrs following perfusion imaging criteria.
Despite the major benefit associated with MT, more than 50% of the patients remain disabled at 3 months. Reperfusion rates after MT are critical to determine functional outcome. However, complete reperfusion is obtained in only 50 % of the patients, due to, at least in part, erratic emboli and/or no-reflow processes. The aim of this study is to evaluate the efficacy of glenzocimab in addition to EVT and compared to EVT plus placebo, whether or not associated with ntravenous thrombolysis (IVT), on functional outcome at day 90.
- Conditions
- Stroke, Acute, Stroke, Ischemic
- Being tested
- Glenzocimab, Placebo
- Keywords
- Platelet glycoprotein VI, Endovascular therapy
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlenzocimabDrug
Glenzocimab (ACT-017, Acticor Biotech) is formulated for IV administration as a sterile product with 20 mM sodium citrate and 130 mM sodium chloride buffer at pH of 5.0.
It is supplied for clinical trial use in vials containing 50 mL of the drug product at a concentration of 10 mg/mL.
Each vial contains 500 mg of glenzocimab. Two vials (2x500 mg) of glenzocimab should be administered concomitantly for eligible patients for a total daily dose of 1g.
Glenzocimab is intended to be administered as an IV infusion over 6 hrs, with 1/4 of the dose administered by a 15-minute bolus and 3/4 of the dose administered by 5h45min-slow infusion.
PlaceboDrug
Placebo of glenzocimab is 0.9%NaCl (Acticor Biotech) for IV administration. It is supplied for clinical trial use in vials of 50 mL. Two vials of placebo of glenzocimab should be administered concomitantly for eligible patients.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Glenzocimab | Experimental | Not described Receives: Drug: Glenzocimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy mRS 90
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.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead.
Measured: 90 days
Secondary outcomes (13)
Favorable functional outcome
Favorable functional outcome defined by a mRS ≤ 2 at day 90 +/- 15 days
Measured: 90 days
Severe handicap
Proportion of patients with a severe handicap: mRS equal to 4, 5 or 6 at day 90 +/- 15 days
Measured: 90 days
Survival
Overall survival at 90 days and 1 year
Measured: 90 days and 1 year
Early reperfusion outcomes : volume
Stroke volume by MRI at 24 hrs
Measured: 24 hours
Early reperfusion outcomes : eTICI
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)
Measured: 24 hours
Early reperfusion outcomes NIHSS
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.
Measured: 24 hours
Quality of life
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.
Measured: 90 days and 1 year
IntraCranial Hemorrhages
Incidence of symptomatic or non-symptomatic IntraCranial Hemorrhages (ICH) at 24 hrs
Measured: 24 hours
Symptomatic IntraCranial Hemorrhages
Incidence of symptomatic IntraCranial Hemorrhages (ICH) at 24 hrs
Measured: 24 hours
Non-Symptomatic IntraCranial Hemorrhages
Incidence of non-symptomatic IntraCranial Hemorrhages (ICH) at 24 hrs
Measured: 24 hours
Adverse event
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
Measured: 24 hours, 7 days, 30 days, 90 days
Bleeding relating events
Incidence of bleeding-related events at 90 days
Measured: 90 days
Anti-glenzocimab antibodies
Anti-glenzocimab antibodies (ADA) blood concentration at 3 months for 50 patients.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start3 Jan 2023
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double blinded, multicentre, placebo controlled study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559398
- Sponsor's protocol ID
- APHP 201028 / ACT-CS-004
- Other IDs
- 2021-000889-16
- Acronym
- GREEN
- Status last verified
- Jul 2026
- First submitted
- 26 Sep 2022
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mazighi M, Lambert J, Gory B, Seners P, Calviere L, Cho TH, Aghetti A, Pasi M, Boulouis G, Lapergue B, Consoli A, Turc G, Rouchaud A, Wolff V, Pop R, Suissa L, Richard S, Cordonnier C, Arquizan C, Costalat V, Guedon A, Cognard C, Mameri L, Escalard S, Redjem H, Smajda S, Robichon E, Al Raaisi A, Boisseau W, Blanc R, Maier B, Boursin P, Dubus E, Desilles JP, Piotin M, Rigon MR, Olivot JM. Glenzocimab for reperfusion in the setting of endovascular therapy for brain infarction: GREEN study. J Neurointerv Surg. 2026 May 14;18(6):1539-1544. doi: 10.1136/jnis-2025-023606.
PubMed 40866207
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glenzocimab for REperfusion in the Setting of Endovascular Therapy for Brain infarctioN: GREEN Study
- ClinicalTrials.gov ID
- NCT05559398
- Acronym / sponsor ID
- GREEN / APHP 201028 / ACT-CS-004
- Conditions
- Stroke, Acute, Stroke, Ischemic
- Keywords
- Platelet glycoprotein VI, Endovascular therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 29 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Emergent reperfusion is the main goal for acute ischemic stroke therapy (AIS). Endovascular therapy (EVT) is recommended within 6 hrs of stroke onset, and up to 24 hrs following perfusion imaging criteria.
Despite the major benefit associated with MT, more than 50% of the patients remain disabled at 3 months. Reperfusion rates after MT are critical to determine functional outcome. However, complete reperfusion is obtained in only 50 % of the patients, due to, at least in part, erratic emboli and/or no-reflow processes. The aim of this study is to evaluate the efficacy of glenzocimab in addition to EVT and compared to EVT plus placebo, whether or not associated with ntravenous thrombolysis (IVT), on functional outcome at day 90.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double blinded, multicentre, placebo controlled study
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Glenzocimab | Experimental | Drug: Glenzocimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Age 18 years or older (Age≥18 years)
- No significant pre-stroke disability (pre-stroke mRS must be equal to 0 or 1);
- Indication of EVT within the time-window of 0 to 24 hrs in participants treated with or without intravenous thrombolysis;
- Participants presenting with a target mismatch defined by an initial infarct volume (ischemic core) of less than 70 ml, a ratio of volume of ischemic tissue to initial infarct volume of 1.8 or more, and an absolute volume of potentially reversible ischemia (penumbra) of 15 ml or more on magnetic resonance imaging (MRI) or, when this is not possible, on perfusion computed tomography (CTP);
- Occlusion of the cervical or intracranial internal carotid artery (ICA) or the proximal middle cerebral artery (MCA - M1 and M2), on magnetic resonance angiography (MRA) or, when this is not possible, on CT angiography (CTA);
Key exclusion criteria (19 listed)
- Contraindications to EVT;
- Contraindication to contrast agents
- Pre-existing neurologic and psychiatric disease with mRS ≥ 3;
- Unknown symptom's onset;
- Patients under or needing immediate DAPT administration;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlenzocimabGlenzocimab (ACT-017, Acticor Biotech) is formulated for IV administration as a sterile product with 20 mM sodium citrate and 130 mM sodium chloride buffer at pH of 5.0. It is supplied for clinical trial use in vials containing 50 mL of the drug product at a concentration of 10 mg/mL. Each vial contains 500 mg of glenzocimab. Two vials (2x500 mg) of glenzocimab should be administered concomitantly for eligible patients for a total daily dose of 1g. Glenzocimab is intended to be administered as an IV infusion over 6 hrs, with 1/4 of the dose administered by a 15-minute bolus and 3/4 of the dose administered by 5h45min-slow infusion. | Drug | Glenzocimab |
| PlaceboPlacebo of glenzocimab is 0.9%NaCl (Acticor Biotech) for IV administration. It is supplied for clinical trial use in vials of 50 mL. Two vials of placebo of glenzocimab should be administered concomitantly for eligible patients. | Drug | Placebo |
Primary outcome
Efficacy mRS 90
Time frame: 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.
13 secondary outcomes
Favorable functional outcome
Time frame: 90 days
Severe handicap
Time frame: 90 days
Survival
Time frame: 90 days and 1 year
Early reperfusion outcomes : volume
Time frame: 24 hours
Early reperfusion outcomes : eTICI
Time frame: 24 hours
Early reperfusion outcomes NIHSS
Time frame: 24 hours
Quality of life
Time frame: 90 days and 1 year
IntraCranial Hemorrhages
Time frame: 24 hours
Symptomatic IntraCranial Hemorrhages
Time frame: 24 hours
Non-Symptomatic IntraCranial Hemorrhages
Time frame: 24 hours
Adverse event
Time frame: 24 hours, 7 days, 30 days, 90 days
Bleeding relating events
Time frame: 90 days
Anti-glenzocimab antibodies
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Derived from this study: PubMed 40866207Mazighi M, Lambert J, Gory B, Seners P, Calviere L, Cho TH, Aghetti A, Pasi M, Boulouis G, Lapergue B, Consoli A, Turc G, Rouchaud A, Wolff V, Pop R, Suissa L, Richard S, Cordonnier C, Arquizan C, Costalat V, Guedon A, Cognard C, Mameri L, Escalard S, Redjem H, Smajda S, Robichon E, Al Raaisi A, Boisseau W, Blanc R, Maier B, Boursin P, Dubus E, Desilles JP, Piotin M, Rigon MR, Olivot JM. Glenzocimab for reperfusion in the setting of endovascular therapy for brain infarction: GREEN study. J Neurointerv Surg. 2026 May 14;18(6):1539-1544. doi: 10.1136/jnis-2025-023606.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke, Acute
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Glenzocimab in people with Stroke, Acute and Stroke, Ischemic, run by Assistance Publique - Hôpitaux de Paris at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy mRS 90 (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05559398, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.