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Branch Atheromatous DiseasePhase 3BRANTNCT06037889

Efficacy and Safety of Tirofiban for Patients With BAD (BRANT)

A Phase 3 study testing Tirofiban, Aspirin tablet and Clopidogrel tablet in people with Branch Atheromatous Disease, run by Peking Union Medical College Hospital at 25 sites in China.

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

Branch atheromatous disease (BAD)-related stroke, characterized by subcortical single infarcts without severe stenosis of the large artery, but with a clear atherosclerotic mechanism, is now regarded as a separate stroke type. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Branch Atheromatous Disease
What is being tested?
Tirofiban, Aspirin tablet and Clopidogrel tablet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
516 participants
Where
25 sitesChina
Study dates
9 Nov 2023to 26 Feb 2026
Phase
Phase 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 18-75 years old
  • Acute ischemic stroke
  • Time from onset to randomization ≤48h; if onset time is unknown, time from last known well to randomization ≤48h
  • Meet the following BAD Diagnostic Imaging Criteria
  • 4.1. DWI infarcts: single (isolated) deep (subcortical) infarcts;
  • 4.2. The culprit arteries are either Lenticulostriate artery (LSA) or Paramedian pontine artery (PPA), and the infarct lesion on DWI conforms to one of the following characteristics (A/B): A. LSA: 1) "Comma-like" infarct lesions with "Fan-shaped" extension from bottom to top in the coronal plane; or 2) ≥ 3 layers (layer thickness 5-7 mm) on axial DWI brain images; B. PPA: The infarct lesion extends from the deep pons to the ventral pons on the axial DWI brain images;
  • 4.3. No more than 50% stenosis on the parent artery of the criminal artery (i.e. corresponding basilar or middle cerebral artery) (Confirmed by magnetic resonance angiography [MRA] or computed tomography angiography [CTA] or digital substraction angiography [DSA]).
  • Singed informed consent by the patient or legally authorized representatives.

Who cannot join

  • Transient ischemic attack (TIA)
  • Intracranial hemorrhagic diseases, vascular malformations, aneurysms, brain abscesses, malignant space-occupying lesions, or other non-ischemic intracranial lesions detected by baseline CT/MRI, or MRA/CTA/DSA;
  • Presence of ≥50% stenosis in extracranial artery in tandem relationship ipsilateral to the lesion;
  • Cardiogenic embolism: atrial fibrillation, myocardial infarction, heart valve disease, dilated cardiomyopathy, infective endocarditis, atrioventricular block disease, heart rate less than 50 beats per minute
  • Have received or plan to receive endovascular therapy or thrombolysis after onset;
  • Stroke of other clear causes, e.g., moyamoya disease, arterial dissection, vasculitis, etc.
Show all 20Show fewer
  • modified Rankin Scale ≥2 before onset
  • Use of tirofiban within 1 week before or after onset
  • Low platelets (<100×10^9 /L), or Prothrombin time >1.3 times of the upper normal limit, or INR >1.5, or other systemic hemorrhagic tendencies such as hematologic disorders
  • Elevation of ALT or AST more than 1.5 times the upper normal limit;
  • Glomerular filtration rate <60 ml/min/1.73m^2
  • Known malignant tumors
  • History of trauma or major surgical intervention within 6 weeks prior to onset
  • History of intracranial hemorrhage
  • Active or recent history(within 30 days prior to onset) of clinical bleeding (e.g., gastrointestinal bleeding)
  • Malignant hypertension (systolic blood pressure >200 mmHg, or diastolic blood pressure >120 mmHg)
  • Life expectancy ≤ 6 months
  • Contraindications of 3 T MRI examination
  • Pregnant or lactating women
  • Have participated in another clinical trial within 3 months prior to the date of informed consent, or are participating in another clinical trial.

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

China25 sites

  • The second hospital of Baoding

    Baoding, Hebei, 071051

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

  • Beijing Shunyi Hospital

    Beijing, Beijing Municipality, 101300

  • Beijing Shijitan Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • The First Hospital of Tsinghua University

    Beijing, Beijing Municipality

  • Botou City Hospital

    Botou, Hebei

  • Cangzhou Central Hospital

    Cangzhou, Hebei

  • Chengde Central Hospital

    Chengde, Hebei, 067024

  • Affiliated Hospital of Chifeng University

    Chifeng, Hebei, 024099

  • Deyang People's Hospital

    Deyang, Sichuan, 618099

  • Shengli Oilfield Central Hospital

    Dongying, Shandong, 257099

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

  • Hengshui People's Hospital

    Hengshui, Hebei, 053099

  • Jinan Central Hospital

    Jinan, Shandong, 250013

  • Tibet Autonomous Region People's Hospital

    Lhasa, Tibet, 850000

  • Meihekou Central Hospital

    Meihekou, Jilin, 135022

  • Mianyang Central Hospital

    Mianyang, Sichuan, 621099

  • Yellow River SANMENXIA Hospital

    Sanmenxia, Henan

  • The First People's Hospital of Shangqiu

    Shangqiu, Henan, 476005

  • North China University of Science and Technology Affiliated Hospital

    Tangshan, Hebei, 063000

  • The Second Hospital of Tianjin Medical University

    Tianjing, Tianjing, 300211

  • The First Affiliated Hospital of Xinxiang Medical Unversity

    Xinxiang, Henan, 453100

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, 221009

  • The First People's Hospital of Yibin

    Yibin, Sichuan, 644000

  • The Second People's Hospital of Yibin

    Yibin, Sichuan, 644000

Other trials in China

About this study

Official title: Efficacy and Safety of Tirofiban in Patients With Acute Branch Atheromatous Disease (BAD)- Related Stroke (BRANT)

Branch atheromatous disease (BAD)-related stroke, characterized by subcortical single infarcts without severe stenosis of the large artery, but with a clear atherosclerotic mechanism, is now regarded as a separate stroke type. BAD is associated with early neurological deterioration and poor prognosis, but is lack of effective therapy. The goal of this randomized controlled trial is to test the efficacy and safety of intravenous tirofiban in patients with acute ischemic stroke caused by branch atheromatous disease. The main question it aims to answer is: Compared with standard antiplatelet therapy based on current stroke guideline, whether tirofiban used in acute phase of BAD could improve the proportion of excellent functional outcome (modified Rankin Scale: 0-1) at 90 days. Researcher will also compare the rate of major bleeding between treatment and control groups.

Read the detailed description

BRANT study is a multicenter, randomized, open label, blinded endpoint, Parallel controlled trial with the primary null hypothesis that, in patients with acute BAD-related stroke, there is no difference in the proportion of excellent outcome in those treated with intravenous Tirofiban compared with those treated with standard antiplatelet therapy based on guideline when subjects are randomized within 48 hours of stroke onset.

The primary objective is to determine whether intravenous tirofiban (a loading dose of 0.4ug/kg/min*30min followed by a maintenance dose of 0.1ug/kg/min*47.5h) is effective in increasing the proportion of excellent functional outcome (mR: 0-1) at 90 days, when initiated within 48 hours of onset. The active comparator is standard antiplatelet therapy based on guideline [ie, 1) aspirin 150-300 mg qd, OR 2) aspirin 100 mg qd plus clopidogrel 75 mg qd] for 48 hours.

Patients with acute BAD-related stroke between 18 and 75 years old, who can be randomized within 48 hours of onset, and meet the BAD Diagnostic Imaging Criteria, will be enrolled. All patients will conduct MRI before randomization.

Subjects will be randomized 1:1 (Tirofiban: Standard antiplatelet therapy). The subjects' eligibility will be assessed by site investigator prior to accessing the Randomization Module, which is generated via the dynamic block randomization method. Only certified and trained personnel can access the randomization website, who will get the information of treatment (ie, Tirofiban or standard antiplatelet therapy) after the subject has be determined eligible.

The treatment period is 48 hours for both study groups. A total of 516 eligible patients will be enrolled. Each participant will be followed for 90 days from randomization. The primary outcome will be assessed by well-trained senior neurologists blinded to the treatment. All the clinical and safety events will be re-examined by the Clinical Event Committee (CEC), who are blinded during all procedures.

Being tested
Tirofiban, Aspirin tablet, Clopidogrel tablet
Keywords
Branch atheromatous disease, Tirofiban, Stroke, Treatment Outcome, Magnetic Resonance Imaging
Medical subject headings
Stroke

What participants receive

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

  • TirofibanDrug

    Also called Tirofiban Hydrochloride and Sodium Chloride Injection

    Tirofiban, a GPIIb/IIIa receptor inhibitor. Intravenous administration.

  • Aspirin tabletDrug

    Aspirin. Oral administration.

  • Clopidogrel tabletDrug

    Clopidogrel. Oral administration.

Study groups in NCT06037889
Study groupRoleWhat they receive
Tirofiban groupExperimentalIntravenous tirofiban will be administered immediately after randomization for a total duration of 48h with a loading dose of 0.4ug/kg/min*30min, followed by a maintenance dose of 0.1ug/kg/min*47.5h.
Receives: Drug: Tirofiban
Standard antiplatelet therapy groupActive comparatorStandard antiplatelet therapy based on Chinese stroke guideline will be administered after randomization for a total duration of 48h, as the two following types: 1) aspirin 150-300 mg qd, or 2) aspirin 100 mg qd plus clopidogrel 75 mg qd. The time for administration of antiplatelet drugs will be determined by the doctor in conjunction with the participants' use of antiplatelet or anticoagulant medication in the 24h prior to randomization, but the drug should be given as soon as possible after randomization.
Receives: Drug: Aspirin tablet; Drug: Clopidogrel tablet

What is being measured

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

  1. Excellent functional outcome

    Primary efficacy outcome: Excellent functional outcome is defined as modified Rankin Scale score: 0-1.

    Modified Rankin Scale, a commonly used scale for measuring the degree of dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. 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 - Death.

    Measured: 90 days

Secondary outcomes (27)

  1. Excellent functional outcome

    modified Rankin Scale score: 0-1

    Measured: 7 days

  2. mRS

    The modified Rankin Scale (mRS) is a commonly used 7-point ordinal scale ranging from 0 (no symptoms) to 6 (death), used to measure the degree of dependence in daily activities among patients with stroke or other neurological disabilities. The distribution of mRS scores at 7 and 90 days will be compared between the two study groups as an ordinal outcome, with higher scores indicating worse outcomes.

    Measured: 7 and 90 days

  3. Early neurological deterioration

    The presence of END is determined by an increase of ≥ 4 points in the NIHSS or an increase of ≥2 points in the NIHSS motor score. In addition, NIHSS motor score refers to bilateral upper and lower extremity mobility scores. The baseline NIHSS score for the calculation of END is the first clinician-evaluated and recorded NIHSS score after onset. The time frame for post-randomization END is within 7 days of randomization.

    Measured: 7 days of randomization

  4. NIHSS score

    The NIHSS is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. 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: 7 days and 90 days

  5. Barthel index score

    The Barthel Index (BI) is tool to measure the extent to which somebody can function independently and has mobility in activities of daily living (ADL), including 10 aspects: feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing. Higher score indicates better performance in activities of daily living.

    Measured: 90 days

  6. Ischemic stroke

    Number of participants with new-onset ischemic stroke, confirmed by senior neurologists and the Clinical Event Committee.

    Measured: 90 days

  7. Stroke

    Number of participants with new-onset ischemic or hemorrhagic stroke, confirmed by senior neurologists and the Clinical Event Committee.

    Measured: 90 days

  8. TIA

    Number of participants with new-onset transient ischemic attack (TIA), confirmed by senior neurologists and the Clinical Event Committee.

    Measured: 90 days

  9. Composite endpoint

    Number of participants with new-onset stroke, myocardial Infarction, or all-cause death, confirmed by the Clinical Event Committee.

    Measured: 90 days

  10. Proportion of Major bleeding

    Proportion of major bleeding defined by the PLATO criteria.

    Measured: 7 days and 90 days

  11. Serious adverse events

    Serious adverse events

    Measured: 90 days

  12. Adverse events

    Adverse events

    Measured: 90 days

  13. All-cause death

    All-cause death

    Measured: 90 days

  14. Changes in hemoglobin

    Blood test of the count of hemoglobin, g/L

    Measured: 48 hours

  15. Changes in the count of red blood cell

    Blood test of the count of red blood cell, 10^12/L

    Measured: 48 hours

  16. Changes in the count of white blood cell

    Blood test of the count of white blood cell, 10^9/L

    Measured: 48 hours

  17. Changes in the count of platelets

    Blood test of the count of platelets, 10^9/L

    Measured: 48 hours

  18. Changes in alanine transaminase

    Serum biochemical test for alanine transaminase

    Measured: 48 hours

  19. Changes in aspartate aminotransferase

    Serum biochemical test for aspartate aminotransferase

    Measured: 48 hours

  20. Changes in direct bilirubin

    Serum biochemical test for the concentration of direct bilirubin

    Measured: 48 hours

  21. Changes in indirect bilirubin

    Serum biochemical test for the concentration of indirect bilirubin

    Measured: 48 hours

  22. Changes in concentration of Na

    Serum biochemical test for the concentration of sodium, mmol/L

    Measured: 48 hours

  23. Changes in the concentration of K

    Serum biochemical test for the concentration of potassium, mmol/L

    Measured: 48 hours

  24. Changes in the concentration of creatinine

    Serum biochemical test for creatinine

    Measured: 48 hours

  25. Changes in the concentration of albumin

    Serum biochemical test for albumin

    Measured: 48 hours

  26. Changes in the urinary occult blood

    The test of urine blood (BLD). Negative or positive.

    Measured: 48 hours

  27. Changes in the fecal occult blood

    The test of occult blood (Occult blood, OB). Negative or positive

    Measured: 48 hours

Timeline

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

  1. First posted14 Sep 2023
  2. Study start9 Nov 2023
  3. Primary completion26 Feb 2026
  4. Study completion26 Feb 2026

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
multi-center, randomized, open label, blinded endpoint, parallel controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
516 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06037889
Sponsor's protocol ID
BAD-RCT202201
Acronym
BRANT
Status last verified
Nov 2025
First submitted
7 Sep 2023
Last updated
15 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data that support the findings of this study are available from the corresponding author on reasonable request.

Publications

  • Petrone L, Nannoni S, Del Bene A, Palumbo V, Inzitari D. Branch Atheromatous Disease: A Clinically Meaningful, Yet Unproven Concept. Cerebrovasc Dis. 2016;41(1-2):87-95. doi: 10.1159/000442577. Epub 2015 Dec 16.

    PubMed 26671513

  • Bang OY. Considerations When Subtyping Ischemic Stroke in Asian Patients. J Clin Neurol. 2016 Apr;12(2):129-36. doi: 10.3988/jcn.2016.12.2.129. Epub 2016 Jan 28.

    PubMed 26833987

  • Zhang C, Wang Y, Zhao X, Wang D, Liu L, Wang C, Pu Y, Zou X, Du W, Jing J, Pan Y, Wong KS, Wang Y; Chinese Intracranial Atherosclerosis Study Group. Distal single subcortical infarction had a better clinical outcome compared with proximal single subcortical infarction. Stroke. 2014 Sep;45(9):2613-9. doi: 10.1161/STROKEAHA.114.005634. Epub 2014 Jul 22.

    PubMed 25052317

  • Jeong HG, Kim BJ, Yang MH, Han MK, Bae HJ. Neuroimaging markers for early neurologic deterioration in single small subcortical infarction. Stroke. 2015 Mar;46(3):687-91. doi: 10.1161/STROKEAHA.114.007466. Epub 2015 Feb 12.

    PubMed 25677600

  • Seners P, Ben Hassen W, Lapergue B, Arquizan C, Heldner MR, Henon H, Perrin C, Strambo D, Cottier JP, Sablot D, Girard Buttaz I, Tamazyan R, Preterre C, Agius P, Laksiri N, Mechtouff L, Bejot Y, Duong DL, Mounier-Vehier F, Mione G, Rosso C, Lucas L, Papassin J, Aignatoaie A, Triquenot A, Carrera E, Niclot P, Obadia A, Lyoubi A, Garnier P, Crainic N, Wolff V, Tracol C, Philippeau F, Lamy C, Soize S, Baron JC, Turc G; MINOR-STROKE Collaborators. Prediction of Early Neurological Deterioration in Individuals With Minor Stroke and Large Vessel Occlusion Intended for Intravenous Thrombolysis Alone. JAMA Neurol. 2021 Mar 1;78(3):321-328. doi: 10.1001/jamaneurol.2020.4557.

    PubMed 33427887

  • Duan Z, Fu C, Chen B, Xu G, Tao L, Tang T, Hou H, Fu X, Yang M, Liu Z, Zhang X. Lesion patterns of single small subcortical infarct and its association with early neurological deterioration. Neurol Sci. 2015 Oct;36(10):1851-7. doi: 10.1007/s10072-015-2267-1. Epub 2015 Jun 2.

    PubMed 26032577

  • Helleberg BH, Ellekjaer H, Indredavik B. Outcomes after Early Neurological Deterioration and Transitory Deterioration in Acute Ischemic Stroke Patients. Cerebrovasc Dis. 2016;42(5-6):378-386. doi: 10.1159/000447130. Epub 2016 Jun 29.

    PubMed 27351585

  • Heitsch L, Ibanez L, Carrera C, Binkley MM, Strbian D, Tatlisumak T, Bustamante A, Ribo M, Molina C, Davalos A, Lopez-Cancio E, Munoz-Narbona L, Soriano-Tarraga C, Giralt-Steinhauer E, Obach V, Slowik A, Pera J, Lapicka-Bodzioch K, Derbisz J, Sobrino T, Castillo J, Campos F, Rodriguez-Castro E, Arias-Rivas S, Segura T, Serrano-Heras G, Vives-Bauza C, Diaz-Navarro R, Tur S, Jimenez C, Marti-Fabregas J, Delgado-Mederos R, Arenillas J, Krupinski J, Cullell N, Torres-Aguila NP, Muino E, Carcel-Marquez J, Moniche F, Cabezas JA, Ford AL, Dhar R, Roquer J, Khatri P, Jimenez-Conde J, Fernandez-Cadenas I, Montaner J, Rosand J, Cruchaga C, Lee JM; International Stroke Genetics Consortium. Early Neurological Change After Ischemic Stroke Is Associated With 90-Day Outcome. Stroke. 2021 Jan;52(1):132-141. doi: 10.1161/STROKEAHA.119.028687. Epub 2020 Dec 15.

    PubMed 33317415

  • Park MG, Oh EH, Kim BK, Park KP. Intravenous tissue plasminogen activator in acute branch atheromatous disease: Does it prevent early neurological deterioration? J Clin Neurosci. 2016 Nov;33:194-197. doi: 10.1016/j.jocn.2016.04.011. Epub 2016 Jul 21.

    PubMed 27452127

  • Seners P, Turc G, Oppenheim C, Baron JC. Incidence, causes and predictors of neurological deterioration occurring within 24 h following acute ischaemic stroke: a systematic review with pathophysiological implications. J Neurol Neurosurg Psychiatry. 2015 Jan;86(1):87-94. doi: 10.1136/jnnp-2014-308327. Epub 2014 Jun 26.

    PubMed 24970907

  • Ospel JM, Menon BK, Demchuk AM, Almekhlafi MA, Kashani N, Mayank A, Fainardi E, Rubiera M, Khaw A, Shankar JJ, Dowlatshahi D, Puig J, Sohn SI, Ahn SH, Poppe A, Calleja A, Hill MD, Goyal M. Clinical Course of Acute Ischemic Stroke Due to Medium Vessel Occlusion With and Without Intravenous Alteplase Treatment. Stroke. 2020 Nov;51(11):3232-3240. doi: 10.1161/STROKEAHA.120.030227. Epub 2020 Oct 19.

    PubMed 33070714

  • Wu X, Liu Y, Nie C, Kang Z, Wang Q, Sun D, Li H, Liu Y, Mei B. Efficacy and Safety of Intravenous Thrombolysis on Acute Branch Atheromatous Disease: A Retrospective Case-Control Study. Front Neurol. 2020 Jul 7;11:581. doi: 10.3389/fneur.2020.00581. eCollection 2020.

    PubMed 32733357

  • Yi X, Zhou Q, Wang C, Lin J, Chai Z. Aspirin plus clopidogrel may reduce the risk of early neurologic deterioration in ischemic stroke patients carrying CYP2C19*2 reduced-function alleles. J Neurol. 2018 Oct;265(10):2396-2403. doi: 10.1007/s00415-018-8998-1. Epub 2018 Aug 20.

    PubMed 30128710

  • Yi X, Zhou Q, Zhang Y, Zhou J, Lin J. Variants in clopidogrel-relevant genes and early neurological deterioration in ischemic stroke patients receiving clopidogrel. BMC Neurol. 2020 Apr 28;20(1):159. doi: 10.1186/s12883-020-01703-6.

    PubMed 32345264

  • Wang Q, Chen C, Chen XY, Han JH, Soo Y, Leung TW, Mok V, Wong KS. Low-molecular-weight heparin and early neurologic deterioration in acute stroke caused by large artery occlusive disease. Arch Neurol. 2012 Nov;69(11):1454-60. doi: 10.1001/archneurol.2012.1633.

    PubMed 22893265

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tirofiban, Aspirin tablet and Clopidogrel tablet in people with Branch Atheromatous Disease, run by Peking Union Medical College Hospital at 25 sites in China.

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 8 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 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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?

Excellent functional outcome (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 NCT06037889, which also lists 27 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 15 Apr 2026.

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