Acute Ischemic Stroke AISCLOTNCT07314476
CardioLogical Interventions and Acute strOke Treatment sTudy
An observational study of Acute Ischemic Stroke AIS and Stroke Treatment, run by University of L'Aquila at 1 site in Italy.
Trial summary
The study aims to investigate characteristics and prognosis of ischemic stroke cases following cardiological interventions, focusing on the effectiveness and safety of acute ischemic stroke treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke AIS, Stroke Treatment, PCI Patients
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2026to Dec 2028
- How long will I take part?
- 180 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Acute ischemic stroke in adult patient (>18 years old) after cardiological intervention, male and female.
Who may be able to join
- acute ischemic stroke in adult patient (18 years of age or older) as diagnosed according to the World Health Organization (WHO) criteria;
- stroke with evidence of CT/MRI DWI/FLAIR acute lesion in the first neuroimaging or in the follow-up at 24-48 h;
- interventional cardiological procedures performed within 28 days since the stroke onset (Percutaneuous Coronary Intervention - PCI, Transcatheter Aortic Valve Replacement - TAVR, Baloon Aortic Valvuloplasy - BAV, Percutaneous Mitral Valve Repair or Replacement, Patent Formaen Ovale - PFO - or Atrial Septal Defects - ASD - Closure, Left Atrial Appendage Closure, Transcatheter Pulmonary Valve Replacement, Percutaneous Closure of Paravalvular Leaks);
- written informed consent provided by the patient himself or by proxy (for unconscious patients, cognitively impaired, or aphasic).
Who cannot join
- Stroke-like symptoms due primarily to another non-ischemic/hemorrhagic acute neurological condition or stroke mimics (e.g. severe hypo- or hyperglycemia, migraine with aura, functional disorders, etc);
- Spontaneous and post traumatic hemorrhagic stroke or spontaneous/post-traumatic subarachnoid hemorrhage or subdural hematoma;
- AciuImpossibility to achieve written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Department of Biotechnological and Applied Clinical Sciences
L’Aquila, L'Aquila, 67100
Simona Sacco, MD, +390863499322, simona.sacco@univaq.it
Raffaele Ornello, MD, PhD, +390683499322, raffaele.ornello@univaq.it
About this study
The study aims to investigate characteristics and prognosis of ischemic stroke cases following cardiological interventions, focusing on the effectiveness and safety of acute ischemic stroke treatments.
Read the detailed description
CLOT is a multicenter, observational, ambispective real-world study involving acute ischemic stroke cases occuring after cardiological procedures.
Patients will be recruited at different emergency services and stroke units in Europe. The study will encompass a retrospective (CLOT-R) and prospective (CLOT-P) data collection.
CLOT-R will include cases the occured in the 5 years befor the initation of the study; CLOT-P has a duration of 2 years of enrollement from the study approval at each site and follow-up of 180 days (total duration of 2 years and 180 days). The inclusion criteria are: acute ischemic stroke in adult patient (18 years of age or older) as diagnosed according to the World Health Organization (WHO) criteria; stroke with evidence of CT/MRI DWI/FLAIR acute lesion in the first neuroimaging or in the follow-up at 24-48 h; interventional cardiological procedures performed within 28 days since the stroke onset (Percutaneuous Coronary Intervention - PCI, Transcatheter Aortic Valve Replacement - TAVR, Baloon Aortic Valvuloplasy - BAV, Percutaneous Mitral Valve Repair or Replacement, Patent Formaen Ovale - PFO - or Atrial Septal Defects - ASD - Closure, Left Atrial Appendage Closure, Transcatheter Pulmonary Valve Replacement, Percutaneous Closure of Paravalvular Leaks); written informed consent provided by the patient himself or by proxy (for unconscious patients, cognitively impaired, or aphasic).
Exclusion criteria are: Stroke-like symptoms due primarily to another non-ischemic/hemorrhagic acute neurological condition or stroke mimics (e.g. severe hypo- or hyperglycemia, migraine with aura, functional disorders, etc); Spontaneous and post traumatic hemorrhagic stroke or spontaneous/post-traumatic subarachnoid hemorrhage or subdural hematoma; Impossibility to achieve written informed consent.
The primary outcome of CLOT-R is a descriptive analysis of baseline demographic, clinical, neuroimaging, cardiological procedural and acute stroke treatment characteristics. The secondary outcomes are: effectiveness and safety of intravenous thrombolysis (IVT) with or without mechanical thrombectomy (MT), or MT alone; 90-day post-stroke risk of all-cause and vascular mortality, new ischemic stroke or transient ischemic attack (TIA), myocardial infarction, intracranial hemorrhage or other major bleeding events, disability as measured by the modified Rankin Scale (mRS) score.
The primary outcome of CLOT-P is effectiveness and safety of IVT with or without MT, or MT alone. The secondary outcomes are 90-day and 180-day post-stroke risk of all-cause and vascular mortality, new ischemic stroke or TIA, myocardial infarction, intracranial hemorrhage or other major bleeding events, disability as measured by the mRS score.
The statistic analyses will include Descriptive statistics (baseline characteristics), Poisson regression analysis (incidence of primary and secondary outcomes at each timepoint), Cox regression analysis (time-to-outcomes comparison between groups, identification of outcomes predictors), generalized linear regression (ordinal mRS distribution comparison between maintainers and switchers), risk ratio and risk difference calculation for primary and secondary outcomes comparison (unadjusted and adjusted for confounders), pseudo-randomization (propensity score matching or inverse probability weighting).
The study aims to include in CLOT-P a minimum sample of 400 patients (100 patients for each acute stroke treatment group and 100 untreated) to have reliable estimates of the primary study outcome.
- Conditions
- Acute Ischemic Stroke AIS, Stroke Treatment, PCI Patients, Aortic Valve Replacement, Transcatheter Aortic Valve Replacement (TAVR), Mitral Valve Repair
- Keywords
- acute ischemic stroke, acute ischemic stroke treatments, cardiological intervention
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with ischemic stroke occuring within 28 days after cardiological interventional procedures | Cardiological interventions includes: Percutaneuous Coronary Intervention - PCI, Transcatheter Aortic Valve Replacement - TAVR, Baloon Aortic Valvuloplasy - BAV, Percutaneous Mitral Valve Repair or Replacement, Patent Formaen Ovale - PFO - or Atrial Septal Defects - ASD - Closure, Left Atrial Appendage Closure, Transcatheter Pulmonary Valve Replacement, Percutaneous Closure of Paravalvular Leaks |
What is being measured
The primary outcome is the main question the study is designed to answer.
CLOT-R primary outcome - Stroke severity
Stroke severity assessed via the National Institutes of Health Stroke Scale (NIHSS). Scores on the NIHSS range from 0 to 42, with higher scores indicating more severe neurological deficits.
Measured: from enrollment to 180 days follow-up
CLOT-R primary outcome - Radiology
Number of participants with large vessel occlusion demonstrated on neuroimaging.
Measured: from enrollment to 180-day follow-up
CLOT-R primary outcome - Cardiological procedure
Number of participants who underwent cardiological procedures during which ischemic stroke occurred.
Measured: from enrollment to 180-day follow-up
CLOT-P primary outcome - Efficacy
Number of participants presenting with Modified Rankin Scale (mRS) score ≤2 after revascularization. Scores on the mRS range from 0 to 6, with 0 indicating no symptoms and 6 indicating death. A score of 2 or less indicates functional indipendence.
Measured: 90-day follow-up
CLOT-P primary outcome - safety
Number of participants with symptomatic intracranial hemorrhage after revascularization.
Measured: 90-day follow-up
Secondary outcomes (4)
CLOT-R secondary outcome - Efficacy
Number of participants presenting with Modified Rankin Scale (mRS) score ≤2 after revascularization. Scores on the mRS range from 0 to 6, with 0 indicating no symptoms and 6 indicating death. A score of 2 or less indicates functional indipendence.
Measured: 90-day follow-up
CLOT-R secondary outcome - Safety
Number of patients with symptomatic intracranial hemorrhage after revascularization.
Measured: 90-day follow-up
CLOT-R secondary outcome: Serious Adverse Event (SAE)
Number of patients experiencing Serious Adverse Events (retrospective investigation).
Measured: 90-day follow-up
CLOT-P secondary outcome: Serious Adverse Event (SAE)
Number of patients experiencing Serious Adverse Events (prospective investigation).
Measured: 90-day and 180-day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic Stroke AISStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 400 participants (estimated)
- Target duration
- 180 Days
Sponsor and investigators
- Lead sponsor
- University of L'Aquila
- Sponsor type
- University, hospital or other
- Collaborators
- Rete delle NeuroCardiologie
- Responsible party
- Principal investigator, Simona Sacco, University of L'Aquila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314476
- Sponsor's protocol ID
- 1.0 - 08/02/2025
- Acronym
- CLOT
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
D'Anna L, Demir O, Banerjee S, Malik I. Intravenous Thrombolysis and Mechanical Thrombectomy in Patients with Stroke after TAVI: A Report of Two Cases. J Stroke Cerebrovasc Dis. 2019 Oct;28(10):104277. doi: 10.1016/j.jstrokecerebrovasdis.2019.06.035. Epub 2019 Jul 18.
PubMed 31327683Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2019 Dec;50(12):e344-e418. doi: 10.1161/STR.0000000000000211. Epub 2019 Oct 30.
PubMed 31662037Shah R, Wilkins E, Nichols M, Kelly P, El-Sadi F, Wright FL, Townsend N. Epidemiology report: trends in sex-specific cerebrovascular disease mortality in Europe based on WHO mortality data. Eur Heart J. 2019 Mar 1;40(9):755-764. doi: 10.1093/eurheartj/ehy378.
PubMed 30124820D'Anna L, Abu-Rumeileh S, Merlino G, Ornello R, Foschi M, Diana F, Barba L, Mastrangelo V, Romoli M, Lobotesis K, Bax F, Kuris F, Valente M, Otto M, Korompoki E, Sacco S, Gigli GL, Nguyen TN, Banerjee S. Safety and Outcomes of Mechanical Thrombectomy in Acute Ischemic Stroke Attributable to Cardiological Diseases: A Scoping Review. J Am Heart Assoc. 2024 Sep 3;13(17):e034783. doi: 10.1161/JAHA.124.034783. Epub 2024 Jun 14.
PubMed 38874062
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CardioLogical Interventions and Acute strOke Treatment sTudy
- ClinicalTrials.gov ID
- NCT07314476
- Acronym / sponsor ID
- CLOT / 1.0 - 08/02/2025
- Conditions
- Acute Ischemic Stroke AIS, Stroke Treatment, PCI Patients, Aortic Valve Replacement, Transcatheter Aortic Valve Replacement (TAVR), Mitral Valve Repair
- Keywords
- acute ischemic stroke, acute ischemic stroke treatments, cardiological intervention
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of L'AquilaUniversity, hospital or other
- Collaborators
- Rete delle NeuroCardiologie
- Study start
- Jan 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 2 Jan 2026 (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.
The study aims to investigate characteristics and prognosis of ischemic stroke cases following cardiological interventions, focusing on the effectiveness and safety of acute ischemic stroke treatments.
Detailed description
CLOT is a multicenter, observational, ambispective real-world study involving acute ischemic stroke cases occuring after cardiological procedures.
Patients will be recruited at different emergency services and stroke units in Europe. The study will encompass a retrospective (CLOT-R) and prospective (CLOT-P) data collection.
CLOT-R will include cases the occured in the 5 years befor the initation of the study; CLOT-P has a duration of 2 years of enrollement from the study approval at each site and follow-up of 180 days (total duration of 2 years and 180 days). The inclusion criteria are: acute ischemic stroke in adult patient (18 years of age or older) as diagnosed according to the World Health Organization (WHO) criteria; stroke with evidence of CT/MRI DWI/FLAIR acute lesion in the first neuroimaging or in the follow-up at 24-48 h; interventional cardiological procedures performed within 28 days since the stroke onset (Percutaneuous Coronary Intervention - PCI, Transcatheter Aortic Valve Replacement - TAVR, Baloon Aortic Valvuloplasy - BAV, Percutaneous Mitral Valve Repair or Replacement, Patent Formaen Ovale - PFO - or Atrial Septal Defects - ASD - Closure, Left Atrial Appendage Closure, Transcatheter Pulmonary Valve Replacement, Percutaneous Closure of Paravalvular Leaks); written informed consent provided by the patient himself or by proxy (for unconscious patients, cognitively impaired, or aphasic).
Exclusion criteria are: Stroke-like symptoms due primarily to another non-ischemic/hemorrhagic acute neurological condition or stroke mimics (e.g. severe hypo- or hyperglycemia, migraine with aura, functional disorders, etc); Spontaneous and post traumatic hemorrhagic stroke or spontaneous/post-traumatic subarachnoid hemorrhage or subdural hematoma; Impossibility to achieve written informed consent.
The primary outcome of CLOT-R is a descriptive analysis of baseline demographic, clinical, neuroimaging, cardiological procedural and acute stroke treatment characteristics. The secondary outcomes are: effectiveness and safety of intravenous thrombolysis (IVT) with or without mechanical thrombectomy (MT), or MT alone; 90-day post-stroke risk of all-cause and vascular mortality, new ischemic stroke or transient ischemic attack (TIA), myocardial infarction, intracranial hemorrhage or other major bleeding events, disability as measured by the modified Rankin Scale (mRS) score.
The primary outcome of CLOT-P is effectiveness and safety of IVT with or without MT, or MT alone. The secondary outcomes are 90-day and 180-day post-stroke risk of all-cause and vascular mortality, new ischemic stroke or TIA, myocardial infarction, intracranial hemorrhage or other major bleeding events, disability as measured by the mRS score.
The statistic analyses will include Descriptive statistics (baseline characteristics), Poisson regression analysis (incidence of primary and secondary outcomes at each timepoint), Cox regression analysis (time-to-outcomes comparison between groups, identification of outcomes predictors), generalized linear regression (ordinal mRS distribution comparison between maintainers and switchers), risk ratio and risk difference calculation for primary and secondary outcomes comparison (unadjusted and adjusted for confounders), pseudo-randomization (propensity score matching or inverse probability weighting).
The study aims to include in CLOT-P a minimum sample of 400 patients (100 patients for each acute stroke treatment group and 100 untreated) to have reliable estimates of the primary study outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 180 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with ischemic stroke occuring within 28 days after cardiological interventional procedures | – | –Cardiological interventions includes: Percutaneuous Coronary Intervention - PCI, Transcatheter Aortic Valve Replacement - TAVR, Baloon Aortic Valvuloplasy - BAV, Percutaneous Mitral Valve Repair or Replacement, Patent Formaen Ovale - PFO - or Atrial Septal Defects - ASD - Closure, Left Atrial Appendage Closure, Transcatheter Pulmonary Valve Replacement, Percutaneous Closure of Paravalvular Leaks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute ischemic stroke in adult patient (>18 years old) after cardiological intervention, male and female.
Key inclusion criteria (4 listed)
- acute ischemic stroke in adult patient (18 years of age or older) as diagnosed according to the World Health Organization (WHO) criteria;
- stroke with evidence of CT/MRI DWI/FLAIR acute lesion in the first neuroimaging or in the follow-up at 24-48 h;
- interventional cardiological procedures performed within 28 days since the stroke onset (Percutaneuous Coronary Intervention - PCI, Transcatheter Aortic Valve Replacement - TAVR, Baloon Aortic Valvuloplasy - BAV, Percutaneous Mitral Valve Repair or Replacement, Patent Formaen Ovale - PFO - or Atrial Septal Defects - ASD - Closure, Left Atrial Appendage Closure, Transcatheter Pulmonary Valve Replacement, Percutaneous Closure of Paravalvular Leaks);
- written informed consent provided by the patient himself or by proxy (for unconscious patients, cognitively impaired, or aphasic).
Key exclusion criteria (3 listed)
- Stroke-like symptoms due primarily to another non-ischemic/hemorrhagic acute neurological condition or stroke mimics (e.g. severe hypo- or hyperglycemia, migraine with aura, functional disorders, etc);
- Spontaneous and post traumatic hemorrhagic stroke or spontaneous/post-traumatic subarachnoid hemorrhage or subdural hematoma;
- AciuImpossibility to achieve written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CLOT-R primary outcome - Stroke severity
Time frame: from enrollment to 180 days follow-up
Stroke severity assessed via the National Institutes of Health Stroke Scale (NIHSS). Scores on the NIHSS range from 0 to 42, with higher scores indicating more severe neurological deficits.
CLOT-R primary outcome - Radiology
Time frame: from enrollment to 180-day follow-up
Number of participants with large vessel occlusion demonstrated on neuroimaging.
CLOT-R primary outcome - Cardiological procedure
Time frame: from enrollment to 180-day follow-up
Number of participants who underwent cardiological procedures during which ischemic stroke occurred.
CLOT-P primary outcome - Efficacy
Time frame: 90-day follow-up
Number of participants presenting with Modified Rankin Scale (mRS) score ≤2 after revascularization. Scores on the mRS range from 0 to 6, with 0 indicating no symptoms and 6 indicating death. A score of 2 or less indicates functional indipendence.
CLOT-P primary outcome - safety
Time frame: 90-day follow-up
Number of participants with symptomatic intracranial hemorrhage after revascularization.
4 secondary outcomes
CLOT-R secondary outcome - Efficacy
Time frame: 90-day follow-up
CLOT-R secondary outcome - Safety
Time frame: 90-day follow-up
CLOT-R secondary outcome: Serious Adverse Event (SAE)
Time frame: 90-day follow-up
CLOT-P secondary outcome: Serious Adverse Event (SAE)
Time frame: 90-day and 180-day follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Background: PubMed 31327683D'Anna L, Demir O, Banerjee S, Malik I. Intravenous Thrombolysis and Mechanical Thrombectomy in Patients with Stroke after TAVI: A Report of Two Cases. J Stroke Cerebrovasc Dis. 2019 Oct;28(10):104277. doi: 10.1016/j.jstrokecerebrovasdis.2019.06.035. Epub 2019 Jul 18.
- Background: PubMed 31662037Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2019 Dec;50(12):e344-e418. doi: 10.1161/STR.0000000000000211. Epub 2019 Oct 30.
- Background: PubMed 30124820Shah R, Wilkins E, Nichols M, Kelly P, El-Sadi F, Wright FL, Townsend N. Epidemiology report: trends in sex-specific cerebrovascular disease mortality in Europe based on WHO mortality data. Eur Heart J. 2019 Mar 1;40(9):755-764. doi: 10.1093/eurheartj/ehy378.
- Background: PubMed 38874062D'Anna L, Abu-Rumeileh S, Merlino G, Ornello R, Foschi M, Diana F, Barba L, Mastrangelo V, Romoli M, Lobotesis K, Bax F, Kuris F, Valente M, Otto M, Korompoki E, Sacco S, Gigli GL, Nguyen TN, Banerjee S. Safety and Outcomes of Mechanical Thrombectomy in Acute Ischemic Stroke Attributable to Cardiological Diseases: A Scoping Review. J Am Heart Assoc. 2024 Sep 3;13(17):e034783. doi: 10.1161/JAHA.124.034783. Epub 2024 Jun 14.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke AIS and Stroke Treatment, run by University of L'Aquila at 1 site in Italy.
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matteo Foschi, MD (+390863499322, matteo.foschi@graduate.univaq.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CLOT-R primary outcome - Stroke severity (time frame: from enrollment to 180 days follow-up). The study lists 5 primary outcomes in all. 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 NCT07314476, 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 7 Jan 2026.