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Acute Ischemic StrokePhase 2/3ACTISAVENCT05070260

ACTISAVE: ACuTe Ischemic Stroke Study Evaluating Glenzocimab Used as Add-on Therapy Versus placEbo

A Phase 2/3 study testing Intravenous glenzocimab (ACT017) 1000 mg in people with Acute Ischemic Stroke, run by Acticor Biotech at 10 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

A randomized, double blind, multicenter, multinational, placebo controlled, parallel group, single dose, adaptive phase II/III study. The study evaluates the efficacy and safety of a fixed dose of glenzocimab (1000 mg IV over 6 hrs including initial bolus of 15 minutes) on top of the best standard of care. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
Intravenous glenzocimab (ACT017) 1000 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
438 participants
Where
10 sitesin 2 countries
Study dates
23 Sep 2021to 30 Apr 2024
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

  • Adult male or female patients ≥ 18 years (i.e., at least 18 years old at time of randomization)
  • Having given their own written consent, or legal representative consent, and in any case, in strict accordance with country-specific legal requirements,
  • Presenting with an acute disabling ischemic stroke either in the anterior or in posterior circulation, with or without visible occlusion, with a known time of onset, that is ≤ 4.5 hrs
  • Presenting with a pre-IVT NIHSS ≥ 6
  • In whom IVT is or has been initiated, whether or not patients are additionally eligible to mechanical thrombectomy (MT+ IVT), according to the recommendation of the last guidelines (ASA and ESO recommandations),
  • Women of childbearing potential (WOCBP) must have a negative serum/urine pregnancy test at baseline. Women of childbearing potential, i.e., fertile, are defined as women following menarche and until becoming post-menopausal unless permanently sterile, i.e., having undergone hysterectomy, bilateral salpingectomy and bilateral oophorectomy
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  • 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 WOCBP 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.
  • Patients affiliated to a health insurance - modality depending on country legal requirement

Who cannot join

  • Coma, or NIHSS >25,
  • Patients < 18 years,
  • Protected adults under guardianship or curatorship,
  • Prior ischemic stroke within the past 3 months,
  • mRS pre-stroke known to be ≥ 2,
  • Large (more than 1/3 of the middle cerebral artery) regions of clear hypodensity on Baseline Computed Tomography Angiography (CTA) or Magnetic Resonance Imaging (MRI) or with vascular injection (MRA),
Show all 20Show fewer
  • Significant mass effect with midline shift,
  • Stroke of hemorrhagic origin,
  • Patients likely to require dual antiplatelet therapy (DAPT) within the first 24 hrs after cessation of glenzocimab or placebo infusion for e.g., carotid stenting,
  • Known renal insufficiency (Grades 4-5 - severe or terminal with a creatinine clearance < 30 mL/min using Cockroft formula),
  • Known allergic reaction to contrast agents,
  • Patients under anti-coagulant therapy, except preventative doses of injectable low molecular weight heparin (LMWH),
  • Known ongoing treatment with a mAb,
  • Prior cardiopulmonary resuscitation < 10 days,
  • Childbirth within < 10 days,
  • Seizures at stroke onset if it precludes obtaining an accurate baseline (pre-IVT) NIHSS,
  • Life expectancy (except for stroke) < 3 months,
  • Pregnancy or breastfeeding,
  • Females of childbearing potential not using effective birth control methods,
  • Known current participation in another clinical investigation with experimental drug.

Trial locations and contacts

10 sites in 2 countries.

10 sites in 2 countries

United States9 sites

  • Black Medical center

    Bradenton, Florida, 34209

  • Nova Clinical Research

    Bradenton, Florida, 34209

  • Chattanooga center for neurological research

    Chattanooga, Tennessee, 37403

  • University of Chicago

    Chicago, Illinois, 60637

  • Miami Valley hospital

    Dayton, Ohio, 45409

  • Houston Methodist hospital

    Houston, Texas, 77030

  • Memorial Hermann Hospital

    Houston, Texas, 77030

  • Washington university

    St Louis, Missouri, 63130

  • Northside hospital

    St. Petersburg, Florida, 30342

Other trials in United States

Germany1 site

  • University Clinic Essen

    Essen, 45147

Other trials in Germany

About this study

Official title: A Randomized, Double Blind, Multicenter, Multinational, Placebo Controlled, Parallel Group, Single Dose, Adaptive Efficacy and Safety Study of Glenzocimab Used as an add-on Therapy on Top of Standard of Care un the 4.5 Hours Following an Acute Ischemic Stroke

A randomized, double blind, multicenter, multinational, placebo controlled, parallel group, single dose, adaptive phase II/III study.

The study evaluates the efficacy and safety of a fixed dose of glenzocimab (1000 mg IV over 6 hrs including initial bolus of 15 minutes) on top of the best standard of care.

Read the detailed description

The study evaluates the efficacy and safety of a fixed dose of glenzocimab (1000 mg IV over 6 hrs including initial bolus of 15 minutes) on top of the best standard of care.

In all patients, the IVT should have been initiated prior to/at randomization, and in any case within 4.5 hrs post onset of acute ischemic stroke symptoms. IVT should mandatorily be used according to the approved dosing regimen as described in the product information/SmPC/USPI.

Eligible patients will be randomized and the infusion of glenzocimab or of its matching placebo should be administered as soon as possible but no later than two hours from the start of the thrombolytic agent administration. Transferring the patient to the catheterization room should not delay the Investigational Medicinal Product (IMP) administration.

Patients will be randomized in a 1:1 ratio allocation either to glenzocimab or placebo. Randomization will be minimized for factors as follows: (NIHSS <10 vs. ≥ 10), age group (<65, 65-79, ≥80 years), and type of thrombolytic agent (alteplase vs. tenecteplase) in order to balance each treatment group composition.

The allocation of each patient in all centers to an active treatment or placebo will strictly follow the central randomization scheme. Clinical supplies allocation to centers should provide the necessary material so that any eligible patient can receive the assigned treatment. A central randomization system (IRT - Interactive Response Technology) will be used to manage randomization/stratification and drug shipment. The whole process will be handled in a manner that it is blinded for the treatment received to all involved study personnel.

The IDMC will be composed of 5 independent members (at least 2 clinicians and 1 statistician).

IDMC members will process the information and will issue their recommendations as per the IDMC Charter.

One interim analysis after 100 patients recruited and treated is planned for safety evaluation only.

In case of any urgent safety concern, ad-hoc meetings will be triggered.

Being tested
Intravenous glenzocimab (ACT017) 1000 mg, Intravenous Placebo
Keywords
Haemorrhages GPVI, Thrombolysis, Thrombectomy, Anti-platelet, glenzocimab, ACT017, stroke, GPVI
Medical subject headings
Ischemic Stroke, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intravenous glenzocimab (ACT017) 1000 mgDrug

    Also called Thrombolysis +/- thrombectomy

    Add-on therapy to the standard of Care in the treatment of the acute ischemic stroke symptoms

  • Intravenous PlaceboDrug

    Also called Thrombolysis +/- thrombectomy

    Add-on therapy to the standard of Care in the treatment of the acute ischemic stroke symptoms

Study groups in NCT05070260
Study groupRoleWhat they receive
Intravenous glenzocimab (ACT017) 1000 mgExperimentalIntravenous glenzocimab (ACT017) 1000 mg to be added to thrombolysis +/- mechanical thrombectomy
Receives: Drug: Intravenous glenzocimab (ACT017) 1000 mg
Intravenous PlaceboPlacebo comparatorIntravenous Placebo to be added to thrombolysis +/- mechanical thrombectomy
Receives: Drug: Intravenous Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Binary Poor Outcome on the mRS defined by a score of 4-6 (versions 0-3)

    To show the efficacy of glenzocimab vs. placebo, on the "poor outcome" defined as a mRS score of 4-6 (vs 0-3) assessed at Day 90

    Measured: Day 90

Secondary outcomes (74)

  1. Key Secondary Efficacy Endpoint - mRS

    Binary "Favorable Outcome" on the mRS defined by a score of 0-2 (versus 3-6)

    Measured: Day 90

  2. Mortality

    All cause mortality

    Measured: Day 90

  3. mRS

    To assess the favorable responses defined as mRS score of 0-1

    Measured: Day 90

  4. mRS

    To assess the favorable responses defined as mRS score of 5-6

    Measured: Day 90

  5. Ordinal mRS

    To assess the shift analysis

    Measured: Day 90

  6. Utility Weighted mRS

    To assess the utility weighted mRS (UW-mRS)

    Measured: Day 90

  7. All cause mortality

    To assess all cause mortality

    Measured: 72 hours

  8. ICHs

    Symptomatic and non-symptomatic ICHs

    Measured: 72 hours

  9. Neurological Status Change as assessed by NIHSS value compared to pre-IVT value

    Response defined by a relative decrease (%) in NIHSS value at 24 hours compared to pre-IVT value higher than 30%.

    Relative change (%) in NIHSS value at 24 hrs compared to pre-IVT value

    Measured: 24 hours

  10. Recanalization rate

    To assess recanalization in patients undergoing thrombectomy by eTICI score

    Measured: Day 90

  11. Cerebral tissue reperfusion

    To assess Cerebral tissue reperfusion

    Measured: Day 90

  12. Infarct volume progression and hemorrhagic transformation

    To assess the impact on follow up imaging (follow up infarct volume, infarct growth and volume of hemorrhagic transformation)

    Measured: 24 hrs

  13. Measure of Quality of Life by EuroQol-5 Dimension-5 Level (EQ-5D-5L)

    Quality of Life as assessed by the EuroQol-5 Dimension-5 Level. A Quality-of-Life Scale (EQ-5D-5L)

    Measured: Day 90

  14. Incidence of Deaths

    Deaths within the first 24 hours and over the whole study period until Day 90 (Kaplan-Meier curve)

    Measured: Day 90

  15. Incidence of Symptomatic intracranial hemorrhages

    Symptomatic intracranial hemorrhages, defined by both anatomical imaging (according to Heidelberg's classification) at the time of its occurrence associated with an increase in NIHSS score by 4 points or greater, or death that is not explained otherwise (according to ECASS III study definition (14))

    Measured: 24 hours

  16. Incidence of Non-symptomatic hemorrhages

    Non-symptomatic hemorrhages, seen on 24-hours plain CT-Scan, not present at baseline assessment, once other diagnoses are excluded

    Measured: 24 hours

  17. Incidence of Adverse Events, SAEs, bleeding-related events, and Treatment-Emergent Adverse Events (TEAEs)

    Incidence, nature and severity of Adverse Events, SAEs, bleeding-related events, and Treatment-Emergent Adverse Events (TEAEs)

    Measured: Day 90

  18. Change in vital signs (Blood Pressure) at any visit or discharge as compared to Baseline

    Blood Pressure will be assessed every 30 minutes during the 6 hours (infusion) then every 3 hours up to 24 hours.

    Measured: 24 hours

  19. Change in vital signs (Heart Rate) at any visit or discharge as compared to Baseline

    Heart Rate will be assessed every 30 minutes during the 6 hours (infusion) then every 3 hours up to 24 hours

    Measured: 24 hours

  20. Change in hematology assessments: RBC (Red Blood Cell Count) at 24 hours as compared to Baseline

    % of patient with change in RBC (Red Blood Cell Count) in million/mm3

    Measured: 24 hours

  21. Change in hematology assessments: RBC (Red Blood Cell Count) at Day 7 or discharge as compared to Baseline

    % of patient with change in RBC (Red Blood Cell Count) in million/mm3

    Measured: Day 7

  22. Change in hematology assessments: Hemoglobin at 24 hours as compared to Baseline

    % of patient with change in Hemoglobin in g/100ml

    Measured: 24 hours

  23. Change in hematology assessments: Hemoglobin at Day 7 or discharge as compared to Baseline

    % of patient with change in Hemoglobin in g/100ml

    Measured: Day 7

  24. Change in hematology assessments: Hematocrit at 24 hours as compared to Baseline

    % of patient with change in Hematocrit in %

    Measured: 24 hours

  25. Change in hematology assessments: Hematocrit at 24 hours at Day 7 or discharge as compared to Baseline

    % of patient with change in Hematocrit in %

    Measured: Day 7

  26. Change in hematology assessments: Mean Corpuscular Hemoglobin Volume (MCV) at 24 hours as compared to Baseline

    % of patient with change in Mean Corpuscular Hemoglobin Volume (MCV) in µ3

    Measured: 24 hours

  27. Change in hematology assessments: Mean Corpuscular Hemoglobin Volume (MCV) at Day 7 or discharge as compared to Baseline

    % of patient with change in Mean Corpuscular Hemoglobin Volume (MCV) in µ3

    Measured: Day 7

  28. Change in hematology assessments: Mean corpuscular hemoglobin content (MCHC) at 24 hours as compared to Baseline

    % of patient with change in Mean corpuscular hemoglobin content (MCHC) in pg

    Measured: 24 hours

  29. Change in hematology assessments: Mean corpuscular hemoglobin content (MCHC) at Day 7 or discharge as compared to Baseline

    % of patient with change in Mean corpuscular hemoglobin content (MCHC) in pg

    Measured: Day 7

  30. Change in hematology assessments: Corpuscular hemoglobin concentration (CHC) at 24 hours as compared to Baseline

    % of patient with change in Corpuscular hemoglobin concentration (CHC) in %

    Measured: 24 hours

  31. Change in hematology assessments: Corpuscular hemoglobin concentration (CHC) at Day 7 or discharge as compared to Baseline

    % of patient with change in Corpuscular hemoglobin concentration (CHC) in %

    Measured: Day 7

  32. Change in hematology assessments: Leucocytes(/mm3) at 24 hours as compared to Baseline

    % of patient with change in Leucocytes in /mm3

    Measured: 24 hours

  33. Change in hematology assessments: Leucocytes(/mm3) at Day 7 or discharge as compared to Baseline

    % of patient with change in Leucocytes in /mm3

    Measured: Day 7

  34. Change in hematology assessments: Platelets x 10^9 /L at 24 hours as compared to Baseline

    % of patient with change in Platelets x 10^9 /L

    Measured: 24 hours

  35. Change in hematology assessments: Platelets x 10^9 /L at 24 hours at Day 7 or discharge as compared to Baseline

    % of patient with change in Platelets x 10^9 /L

    Measured: Day 7

  36. Change biochemistry assessments : SGPT (Sérum Glutamate Pyruvate Transaminase) at 24 hours as compared to Baseline

    % of patient with change in SGPT in UI/L

    Measured: 24 hours

  37. Change biochemistry assessments : SGPT at Day 7 or discharge as compared to Baseline

    % of patient with change in SGPT in UI/L

    Measured: Day 7

  38. Change biochemistry assessments : SGOT at 24 hours as compared to Baseline

    % of patient with change in SGOT in UI/L

    Measured: 24 hours

  39. Change biochemistry assessments : SGOT at Day 7 or discharge as compared to Baseline

    % of patient with change in SGOT in UI/L

    Measured: Day 7

  40. Change biochemistry assessments: LDH at 24 hours as compared to Baseline

    % of patient with change in LDH in UI/l

    Measured: 24 hours

  41. Change biochemistry assessments : LDH at Day 7 or discharge as compared to Baseline

    % of patient with change in LDH in UI/l

    Measured: Day 7

  42. Change biochemistry assessments : Cholesterol at 24 hours as compared to Baseline

    % of patient with change in Cholesterol in g/L or mmol/L

    Measured: 24 hours

  43. Change biochemistry assessments : Cholesterol at Day 7 or discharge as compared to Baseline

    % of patient with change in Cholesterol in g/L or mmol/L

    Measured: Day 7

  44. Change biochemistry assessments : Triglycerid at 24 hours as compared to Baseline

    % of patient with change in Triglycerid in g/L or mmol/L

    Measured: 24 hours

  45. Change biochemistry assessments : Triglycerid at Day 7 or discharge as compared to Baseline

    % of patient with change in Triglycerid in g/L or mmol/L

    Measured: Day 7

  46. Change biochemistry assessments : Urea at 24 hours as compared to Baseline

    % of patient with change in Urea in g/L or mmol/L

    Measured: 24 hours

  47. Change biochemistry assessments : Urea at Day 7 or discharge as compared to Baseline

    % of patient with change in Urea in g/L or mmol/L

    Measured: Day 7

  48. Change biochemistry assessments : Creatinin at 24 hours as compared to Baseline

    % of patient with change in Creatinin in mg/L or µM/L

    Measured: 24 hours

  49. Change biochemistry assessments : Creatinin at Day 7 or discharge as compared to Baseline

    % of patient with change in Creatinin in mg/L or µM/L

    Measured: Day 7

  50. Change biochemistry assessments : GFR at 24 hours as compared to Baseline

    % of patient with change in GFR in mL/min/1,73 m²

    Measured: 24 hours

  51. Change biochemistry assessments : GFR at Day 7 or discharge as compared to Baseline

    % of patient with change inGFR in mL/min/1,73 m²

    Measured: Day 7

  52. Change biochemistry assessments : Serum Glucose at 24 hours as compared to Baseline

    % of patient with change in Serum Glucose in g/L

    Measured: 24 hours

  53. Change biochemistry assessments : Serum Glucose at Day 7 or discharge as compared to Baseline

    % of patient with change in Serum Glucose in g/L

    Measured: Day 7

  54. Change biochemistry assessments : D-Dimer at 24 hours as compared to Baseline

    % of patient with change in D-Dimer in µg/L

    Measured: 24 hours

  55. Change biochemistry assessments : D-Dimer at Day 7 or discharge as compared to Baseline

    % of patient with change in D-Dimer in µg/L

    Measured: Day 7

  56. Change biochemistry assessments : Fibrinogen at 24 hours as compared to Baseline

    % of patient with change in Fibrinogen in g/L

    Measured: 24 hours

  57. Change biochemistry assessments : Fibrinogen at Day 7 or discharge as compared to Baseline

    % of patient with change in Fibrinogen in g/L

    Measured: Day 7

  58. Change biochemistry assessments : INR score at 24 hours as compared to Baseline

    % of patient with change in INR Score

    Measured: 24 hours

  59. Change biochemistry assessments : INR score at Day 7 or discharge as compared to Baseline

    % of patient with change in INR Score

    Measured: Day 7

  60. Change biochemistry assessments : PT score at 24 hours as compared to Baseline

    % of patient with change in PT in sec

    Measured: 24 hours

  61. Change biochemistry assessments : PT score at Day 7 or discharge as compared to Baseline

    % of patient with change in PT in sec

    Measured: Day 7

  62. Change biochemistry assessments : aPTT score at 24 hours as compared to Baseline

    % of patient with change in aPTT in sec

    Measured: 24 hours

  63. Change biochemistry assessments : aPTT score at Day 7 or discharge as compared to Baseline

    % of patient with change in aPTT in sec

    Measured: Day 7

  64. Change in dipstick urinalysis assessments: Turbidity at 24 hours as compared to Baseline

    % of patient with change in Change in urinalysis assessments

    Measured: 24 hours

  65. Change in dipstick urinalysis assessments: pH at 24 hours as compared to Baseline

    % of patient with change in Change in urinalysis assessments

    Measured: 24 hours

  66. Change in dipstick urinalysis assessments: Glucose at 24 hours as compared to Baseline

    % of patient with change in Change in urinalysis assessments

    Measured: 24 hours

  67. Change in dipstick urinalysis assessments: Proteins at 24 hours as compared to Baseline

    % of patient with change in Change in urinalysis assessments

    Measured: 24 hours

  68. Change in dipstick urinalysis assessments: Blood at 24 hours as compared to Baseline

    % of patient with change in Change in urinalysis assessments

    Measured: 24 hours

  69. Change in dipstick urinalysis assessments: Leucocytes at 24 hours as compared to Baseline

    % of patient with change in Change in urinalysis assessments

    Measured: 24 hours

  70. Change in dipstick clinical laboratory assessments (urinalysis) at Day 7 or discharge as compared to Baseline

    % of patient with change in Change in urinalysis assessments

    Measured: Day 7

  71. Change in coagulation parameters (INR, PT, a PTT)

    Change in coagulation parameters (INR, PT, aPTT) at 24 hrs

    Measured: 24 hours

  72. ECG changes

    ECG change from baseline on QT, QTc, PR, ST and QRS intervals at 24 hours as compared to Baseline

    Measured: 24 hours

  73. ECG changes

    ECG change from baseline on QT, QTc, PR, ST and QRS intervals at Day 7 as compared to Baseline

    Measured: Day 7

  74. ECG changes

    ECG change from baseline on QT, QTc, PR, ST and QRS intervals at discharge as compared to Baseline

    Measured: Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2021
  2. Study start23 Sep 2021
  3. Primary completion30 Apr 2024
  4. Study completion30 Apr 2024

Resources

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
A randomized, double blind, multicenter, multinational, placebo controlled, parallel group, single dose, adaptive phase II/III study (respectively Part 1 and 2).
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
438 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05070260
Sponsor's protocol ID
ACT-CS-005
Acronym
ACTISAVE
Status last verified
Aug 2023
First submitted
30 Jul 2021
Last updated
3 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Voors-Pette C, Lebozec K, Dogterom P, Jullien L, Billiald P, Ferlan P, Renaud L, Favre-Bulle O, Avenard G, Machacek M, Pletan Y, Jandrot-Perrus M. Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT017, an Antiplatelet GPVI (Glycoprotein VI) Fab. Arterioscler Thromb Vasc Biol. 2019 May;39(5):956-964. doi: 10.1161/ATVBAHA.118.312314.

    PubMed 31017822

  • Renaud L, Lebozec K, Voors-Pette C, Dogterom P, Billiald P, Jandrot Perrus M, Pletan Y, Machacek M. Population Pharmacokinetic/Pharmacodynamic Modeling of Glenzocimab (ACT017) a Glycoprotein VI Inhibitor of Collagen-Induced Platelet Aggregation. J Clin Pharmacol. 2020 Sep;60(9):1198-1208. doi: 10.1002/jcph.1616. Epub 2020 Jun 4.

    PubMed 32500636

  • Kohrmann M, Berrouschot J, Serena J, Bornstein NM, Iversen HK, Kalladka D, Krastev G, Molina CA, Peeters A, Sanak D, Sibon IP, Della Schiava L, Tembl JI, Masjuan J, Soda H, Richard S, Eichlova Z, Czap AL, Avenard G, Binay S, Bougamra S, Comenducci A, Drumez E, Meilhoc A, Pletan Y, Sari A, Toledano E, Grouin JM, Grotta JC; ACTISAVE Study Group. Glenzocimab Efficacy and Safety Added to Intravenous Thrombolysis With or Without Mechanical Thrombectomy in Patients With Acute Ischemic Stroke-ACTISAVE: A Prospective, Randomized, Double-Blind Study. Stroke. 2026 May;57(5):1116-1125. doi: 10.1161/STROKEAHA.125.052935. Epub 2026 Mar 16.

    PubMed 42044230

  • Pottecher J, Raffi F, Jandrot-Perrus M, Binay S, Comenducci A, Desort-Henin V, Francois D, Gharakhanian S, Labart M, Meilhoc A, Toledano E, Pletan Y, Avenard G, Sato VH; GARDEN Investigators. Targeting GPVI with glenzocimab in COVID-19 patients: Results from a randomized clinical trial. PLoS One. 2024 Jun 17;19(6):e0302897. doi: 10.1371/journal.pone.0302897. eCollection 2024.

    PubMed 38885234

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Intravenous glenzocimab (ACT017) 1000 mg in people with Acute Ischemic Stroke, run by Acticor Biotech at 10 sites in 2 countries.

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 19 inclusion and 20 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 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States, Germany. 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?

Binary Poor Outcome on the mRS defined by a score of 4-6 (versions 0-3) (time frame: Day 90). 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 NCT05070260, which also lists 4 linked publications.

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 3 Jul 2024.

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