Clopidogrel, Poor Metabolism ofNCT05566301
Multicentric Study on Clopidogrel Resistance in DAPT for CAS (MULTI-RESCLOSA)
An observational study of Clopidogrel, Poor Metabolism of and Carotid Stenosis, run by IRCCS Policlinico S. Donato at 1 site in Italy.
Trial summary
Spontaneous prospective observational multicentre pharmacological study that aims to evaluate whether, from a statistical point of view, there is a significant difference between the use of Ticagrelor in "non-responders" patients to Clopidogrel undergoing carotid stenting and Clopidogrel in "responders" undergoing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clopidogrel, Poor Metabolism of, Carotid Stenosis
- What is being tested?
- Clopidogrel and Ticagrelor
- How many people
- 1,140 participants
- Where
- 1 siteItaly
- Study dates
- 2 Sep 2021to 31 Dec 2030
- 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: Patients who undergo carotid stenting for a significant carotid stenosis and who are treated with dual antiplatelet therapy using ASA + clopidogrel
Who may be able to join
- adult patients (age> 18 years)
- patients who have given their consent to participate in the study, belonging to the U.O. of Vascular Surgery of the IRCCS Policlinico San Donato and the U.O. of Vascular Surgery of the participating centers and subjected to the treatment of carotid stenosis by stenting technique.
Who cannot join
- underage patients
- patients who have not given their consent to participate in the study,
- patients who have carotid stenosis not susceptible to intervention by stenting
- pregnant or lactating women (such as situations in which carotid stenting is contraindicated regardless of the execution of the study).
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, 1 recruiting
- Recruiting
IRCCS Policlinico San Donato
San Donato Milanese, Milan, 20097
Daniela Mazzaccaro, MD, PhD, 0252774569 ext. 0039, daniela.mazzaccaro@grupposandonato.it
Marco Ranucci, MD
About this study
Official title: MULTIcentric Study About RESistance to CLOpidogrel in Dual Antiplatelet Therapy for Carotid Stenting
Spontaneous prospective observational multicentre pharmacological study that aims to evaluate whether, from a statistical point of view, there is a significant difference between the use of Ticagrelor in "non-responders" patients to Clopidogrel undergoing carotid stenting and Clopidogrel in "responders" undergoing carotid stenting, in the onset of death and major adverse cardiovascular events (MACE) and bleeding events, 1 and 3 months after the procedure. Furthermore, the study aims to evaluate the possible preoperative clinical and pharmacological factors most associated with the phenomenon of resistance to Clopidogrel.
Inclusion criteria:
Read more
The data will be collected on adult patients (age> 18 years) who have given their consent to participate in the study, belonging to the U.O. of Vascular Surgery of the IRCCS Policlinico San Donato and the U.O. of Vascular Surgery of the participating centers and there subjected to the treatment of carotid stenosis by stenting technique.
Exclusion criteria:
Those patients who are minors, who have not given their consent to participate in the study, or who have carotid stenosis not susceptible to intervention by stenting will be excluded from the study. Pregnant or lactating women will also be excluded from the study (such as situations in which carotid stenting is contraindicated regardless of the execution of the study).
Read the detailed description
Patients' records will be reviewed for clinical data (age, sex, height and weight), the presence of cardiovascular risk factors (diabetes mellitus, hypertension, dyslipidemia, smoking habits, coronary artery disease, chronic obstructive pulmonary disease), features of the carotid plaque (type of plaque and degree of carotid stenosis, according to ECST measurement), and status of the contralateral carotid artery. The occurrence of preoperative neurologic symptoms within the previous 6 months will also be recorded, as evaluated by the neurologist.
Preoperative and postoperative drug intake will be investigated, with particular attention to statins, beta blockers, angiotensin-converting enzyme (ACE) inhibitors, antiplatelet therapy and anticoagulant therapy.
Laboratory data such as serum creatinine, platelet counts, Red blood cell Distribution Width (RDW), Prothrombin Time (PT), International Normalized Ratio (INR), activated Partial Thromboplastin Time (aPTT) and ratio will be also assessed.
After operation, patients will be followed up three times in the first year (at 1 month, 6 months, and 12 months) and annually thereafter, using ultrasound. An angio-Computed Tomography scan will be required when complications were detected at ultrasound examination. During follow-up, data will be collected about the occurrence of death, stent thrombosis, cerebrovascular events, cardiac events, major haemorrhagic events.
Determination of the effectiveness of antiplatelet drugs The effectiveness of antiplatelet drugs will be evaluated through the impedance aggregometry test, conducted with the Multiplate® platelet function analysis V2.03.11 (Roche, Basel, Switzerland).
Multiplate® technology is based on the principle of electrical impedance aggregometry for the determination of platelet function on whole blood.
The instrument has five independent channels for parallel measurement and is connected to a computer equipped with specific software for the analysis and display of results in real time.
The blood and reagents are placed in a disposable cuvette containing two pairs of electrodes, representing two independent sensor units for a duplicate measurement. The platelets activated by the specific agonist adhere to the metal surface of the sensors, forming an insulating layer and increasing the electrical impedance between the electrodes. The change in impedance due to adhesion and platelet aggregation is represented as a function of time. The area included within the aggregation curve, used to measure aggregation, is expressed in arbitrary aggregation units (U). Since the change in impedance is measured simultaneously on two sensors, the results of each test are expressed as the average value of the two aggregation curves obtained.
Blood sampling to assess platelet aggregation was performed at the patient's hospitalization (in the event that he was already taking clopidogrel), or at least 6 hours after the start of antiplatelet therapy with clopidogrel.
The aggregometry test evaluates the efficacy of salicylates (ASPI-test, aggregation with the use of arachidonic acid: normal reference values 71-115 U) and the efficacy of drugs that act on the adenosine diphosphate (ADP) receptor such as thienopyridines. (ADP-test, ADP-triggered aggregation: normal reference values 57-113 U), compared to the positive control for platelet reactivity by the thrombin-receptor activating peptide (TRAP)-6 (TRAP-test: normal reference values 84-128 U).
In particular, 4 mL of either arterial or venous whole blood will be collected in a tube containing the specific anticoagulant hirudin. Three hundred µL of whole blood diluted with 300 µL of physiological solution will be placed in a disposable cuvette with the aid of an automatic pipette, and left to incubate at 37 ºC for 3 minutes. After incubation, a specific agonist will be added for the required exam. The platelet aggregation value will be measured over the next 6 minutes.
The effectiveness of clopidogrel is defined by the evidence of ADP-test which results to be under normal reference values, otherwise the patient is considered to be resistant to the effect of the drug.
- Conditions
- Clopidogrel, Poor Metabolism of, Carotid Stenosis
- Being tested
- Clopidogrel, Ticagrelor
- Keywords
- clopidogrel resistance, carotid artery stenting, carotid stenosis, dual antiplatelet therapy, ticagrelor
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
All patients will undergo carotid stenting and dual antiplatelet therapy with ASA + clopidogrel
TicagrelorDrug
All patients will undergo carotid stenting and dual antiplatelet therapy with ASA + clopidogrel
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel | Patients who undergo carotid stenting and dual antiplatelet therapy with ASA + clopidogrel and whose aggregometry test shows correct response to the effect of clopidogrel Receives: Drug: Clopidogrel | |
| Ticagrelor | Patients who undergo carotid stenting and dual antiplatelet therapy with ASA + clopidogrel and whose aggregometry test shows incorrect response to the effect of clopidogrel, therefore therapy is switched to ASA + ticagrelor Receives: Drug: Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Outpatient visit
Measured: 1 month
Death
Outpatient visit
Measured: 3 months
MACE
Major Adverse Cardiovascular Events, Outpatient visit
Measured: 1 month
MACE
Major Adverse Cardiovascular Events, Outpatient visit
Measured: 3 months
Occurrence of major hemorrhagic events
Outpatient visit
Measured: 1 month
Occurrence of major hemorrhagic events
Outpatient visit
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 posted4 Oct 2022
- Study start2 Sep 2021
- Primary completion30 Sep 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Clopidogrel, Poor Metabolism ofStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Mazzaccaro, IRCCS Policlinico S. Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566301
- Sponsor's protocol ID
- MULTI-RESCLOSA v.1 16-2-21
- Status last verified
- Jul 2026
- First submitted
- 28 Sep 2022
- Last updated
- 2 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Huibers A, Halliday A, Bulbulia R, Coppi G, de Borst GJ; ACST-2 Collaborative Group. Antiplatelet Therapy in Carotid Artery Stenting and Carotid Endarterectomy in the Asymptomatic Carotid Surgery Trial-2. Eur J Vasc Endovasc Surg. 2016 Mar;51(3):336-42. doi: 10.1016/j.ejvs.2015.11.002. Epub 2015 Dec 21.
PubMed 26717867Ricotta JJ, Aburahma A, Ascher E, Eskandari M, Faries P, Lal BK; Society for Vascular Surgery. Updated Society for Vascular Surgery guidelines for management of extracranial carotid disease. J Vasc Surg. 2011 Sep;54(3):e1-31. doi: 10.1016/j.jvs.2011.07.031.
PubMed 21889701Bertrand ME, Rupprecht HJ, Urban P, Gershlick AH; CLASSICS Investigators. Double-blind study of the safety of clopidogrel with and without a loading dose in combination with aspirin compared with ticlopidine in combination with aspirin after coronary stenting : the clopidogrel aspirin stent international cooperative study (CLASSICS). Circulation. 2000 Aug 8;102(6):624-9. doi: 10.1161/01.cir.102.6.624.
PubMed 10931801Hurst NL, Nooney VB, Raman B, Chirkov YY, De Caterina R, Horowitz JD. Clopidogrel "resistance": pre- vs post-receptor determinants. Vascul Pharmacol. 2013 Nov-Dec;59(5-6):152-61. doi: 10.1016/j.vph.2013.10.002. Epub 2013 Oct 16.
PubMed 24140755Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators; Freij A, Thorsen M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30.
PubMed 19717846Park MW, Kim CJ, Kim MC, Choo EH, Hwang BH, Park CS, Kim HY, Yoo KD, Jeon DS, Jeong MH, Seung KB, Ahn Y, Chang K. A prospective, multicentre, randomised, open-label trial to compare the efficacy and safety of clopidogrel versus ticagrelor in stabilised patients with acute myocardial infarction after percutaneous coronary intervention: rationale and design of the TALOS-AMI trial. EuroIntervention. 2021 Feb 19;16(14):1170-1176. doi: 10.4244/EIJ-D-20-00187.
PubMed 32718912
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MULTIcentric Study About RESistance to CLOpidogrel in Dual Antiplatelet Therapy for Carotid Stenting
- ClinicalTrials.gov ID
- NCT05566301
- Acronym / sponsor ID
- MULTI-RESCLOSA v.1 16-2-21
- Conditions
- Clopidogrel, Poor Metabolism of, Carotid Stenosis
- Keywords
- clopidogrel resistance, carotid artery stenting, carotid stenosis, dual antiplatelet therapy, ticagrelor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,140 participants (estimated)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 4 Oct 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.
Spontaneous prospective observational multicentre pharmacological study that aims to evaluate whether, from a statistical point of view, there is a significant difference between the use of Ticagrelor in "non-responders" patients to Clopidogrel undergoing carotid stenting and Clopidogrel in "responders" undergoing carotid stenting, in the onset of death and major adverse cardiovascular events (MACE) and bleeding events, 1 and 3 months after the procedure. Furthermore, the study aims to evaluate the possible preoperative clinical and pharmacological factors most associated with the phenomenon of resistance to Clopidogrel.
Inclusion criteria:
The data will be collected on adult patients (age> 18 years) who have given their consent to participate in the study, belonging to the U.O. of Vascular Surgery of the IRCCS Policlinico San Donato and the U.O. of Vascular Surgery of the participating centers and there subjected to the treatment of carotid stenosis by stenting technique.
Exclusion criteria:
Those patients who are minors, who have not given their consent to participate in the study, or who have carotid stenosis not susceptible to intervention by stenting will be excluded from the study. Pregnant or lactating women will also be excluded from the study (such as situations in which carotid stenting is contraindicated regardless of the execution of the study).
Detailed description
Patients' records will be reviewed for clinical data (age, sex, height and weight), the presence of cardiovascular risk factors (diabetes mellitus, hypertension, dyslipidemia, smoking habits, coronary artery disease, chronic obstructive pulmonary disease), features of the carotid plaque (type of plaque and degree of carotid stenosis, according to ECST measurement), and status of the contralateral carotid artery. The occurrence of preoperative neurologic symptoms within the previous 6 months will also be recorded, as evaluated by the neurologist.
Preoperative and postoperative drug intake will be investigated, with particular attention to statins, beta blockers, angiotensin-converting enzyme (ACE) inhibitors, antiplatelet therapy and anticoagulant therapy.
Laboratory data such as serum creatinine, platelet counts, Red blood cell Distribution Width (RDW), Prothrombin Time (PT), International Normalized Ratio (INR), activated Partial Thromboplastin Time (aPTT) and ratio will be also assessed.
After operation, patients will be followed up three times in the first year (at 1 month, 6 months, and 12 months) and annually thereafter, using ultrasound. An angio-Computed Tomography scan will be required when complications were detected at ultrasound examination. During follow-up, data will be collected about the occurrence of death, stent thrombosis, cerebrovascular events, cardiac events, major haemorrhagic events.
Determination of the effectiveness of antiplatelet drugs The effectiveness of antiplatelet drugs will be evaluated through the impedance aggregometry test, conducted with the Multiplate® platelet function analysis V2.03.11 (Roche, Basel, Switzerland).
Multiplate® technology is based on the principle of electrical impedance aggregometry for the determination of platelet function on whole blood.
The instrument has five independent channels for parallel measurement and is connected to a computer equipped with specific software for the analysis and display of results in real time.
The blood and reagents are placed in a disposable cuvette containing two pairs of electrodes, representing two independent sensor units for a duplicate measurement. The platelets activated by the specific agonist adhere to the metal surface of the sensors, forming an insulating layer and increasing the electrical impedance between the electrodes. The change in impedance due to adhesion and platelet aggregation is represented as a function of time. The area included within the aggregation curve, used to measure aggregation, is expressed in arbitrary aggregation units (U). Since the change in impedance is measured simultaneously on two sensors, the results of each test are expressed as the average value of the two aggregation curves obtained.
Blood sampling to assess platelet aggregation was performed at the patient's hospitalization (in the event that he was already taking clopidogrel), or at least 6 hours after the start of antiplatelet therapy with clopidogrel.
The aggregometry test evaluates the efficacy of salicylates (ASPI-test, aggregation with the use of arachidonic acid: normal reference values 71-115 U) and the efficacy of drugs that act on the adenosine diphosphate (ADP) receptor such as thienopyridines. (ADP-test, ADP-triggered aggregation: normal reference values 57-113 U), compared to the positive control for platelet reactivity by the thrombin-receptor activating peptide (TRAP)-6 (TRAP-test: normal reference values 84-128 U).
In particular, 4 mL of either arterial or venous whole blood will be collected in a tube containing the specific anticoagulant hirudin. Three hundred µL of whole blood diluted with 300 µL of physiological solution will be placed in a disposable cuvette with the aid of an automatic pipette, and left to incubate at 37 ºC for 3 minutes. After incubation, a specific agonist will be added for the required exam. The platelet aggregation value will be measured over the next 6 minutes.
The effectiveness of clopidogrel is defined by the evidence of ADP-test which results to be under normal reference values, otherwise the patient is considered to be resistant to the effect of the drug.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel | – | Drug: ClopidogrelPatients who undergo carotid stenting and dual antiplatelet therapy with ASA + clopidogrel and whose aggregometry test shows correct response to the effect of clopidogrel |
| Ticagrelor | – | Drug: TicagrelorPatients who undergo carotid stenting and dual antiplatelet therapy with ASA + clopidogrel and whose aggregometry test shows incorrect response to the effect of clopidogrel, therefore therapy is switched to ASA + ticagrelor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who undergo carotid stenting for a significant carotid stenosis and who are treated with dual antiplatelet therapy using ASA + clopidogrel
Key inclusion criteria (2 listed)
- adult patients (age> 18 years)
- patients who have given their consent to participate in the study, belonging to the U.O. of Vascular Surgery of the IRCCS Policlinico San Donato and the U.O. of Vascular Surgery of the participating centers and subjected to the treatment of carotid stenosis by stenting technique.
Key exclusion criteria (4 listed)
- underage patients
- patients who have not given their consent to participate in the study,
- patients who have carotid stenosis not susceptible to intervention by stenting
- pregnant or lactating women (such as situations in which carotid stenting is contraindicated regardless of the execution of the study).
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 |
|---|---|---|
| ClopidogrelAll patients will undergo carotid stenting and dual antiplatelet therapy with ASA + clopidogrel | Drug | Clopidogrel |
| TicagrelorAll patients will undergo carotid stenting and dual antiplatelet therapy with ASA + clopidogrel | Drug | Ticagrelor |
Primary outcome
Death
Time frame: 1 month
Outpatient visit
Death
Time frame: 3 months
Outpatient visit
MACE
Time frame: 1 month
Major Adverse Cardiovascular Events, Outpatient visit
MACE
Time frame: 3 months
Major Adverse Cardiovascular Events, Outpatient visit
Occurrence of major hemorrhagic events
Time frame: 1 month
Outpatient visit
Occurrence of major hemorrhagic events
Time frame: 3 months
Outpatient visit
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 2 Jul 2026.
- Background: PubMed 26717867Huibers A, Halliday A, Bulbulia R, Coppi G, de Borst GJ; ACST-2 Collaborative Group. Antiplatelet Therapy in Carotid Artery Stenting and Carotid Endarterectomy in the Asymptomatic Carotid Surgery Trial-2. Eur J Vasc Endovasc Surg. 2016 Mar;51(3):336-42. doi: 10.1016/j.ejvs.2015.11.002. Epub 2015 Dec 21.
- Background: PubMed 21889701Ricotta JJ, Aburahma A, Ascher E, Eskandari M, Faries P, Lal BK; Society for Vascular Surgery. Updated Society for Vascular Surgery guidelines for management of extracranial carotid disease. J Vasc Surg. 2011 Sep;54(3):e1-31. doi: 10.1016/j.jvs.2011.07.031.
- Background: PubMed 10931801Bertrand ME, Rupprecht HJ, Urban P, Gershlick AH; CLASSICS Investigators. Double-blind study of the safety of clopidogrel with and without a loading dose in combination with aspirin compared with ticlopidine in combination with aspirin after coronary stenting : the clopidogrel aspirin stent international cooperative study (CLASSICS). Circulation. 2000 Aug 8;102(6):624-9. doi: 10.1161/01.cir.102.6.624.
- Background: PubMed 24140755Hurst NL, Nooney VB, Raman B, Chirkov YY, De Caterina R, Horowitz JD. Clopidogrel "resistance": pre- vs post-receptor determinants. Vascul Pharmacol. 2013 Nov-Dec;59(5-6):152-61. doi: 10.1016/j.vph.2013.10.002. Epub 2013 Oct 16.
- Background: PubMed 19717846Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators; Freij A, Thorsen M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30.
- Background: PubMed 32718912Park MW, Kim CJ, Kim MC, Choo EH, Hwang BH, Park CS, Kim HY, Yoo KD, Jeon DS, Jeong MH, Seung KB, Ahn Y, Chang K. A prospective, multicentre, randomised, open-label trial to compare the efficacy and safety of clopidogrel versus ticagrelor in stabilised patients with acute myocardial infarction after percutaneous coronary intervention: rationale and design of the TALOS-AMI trial. EuroIntervention. 2021 Feb 19;16(14):1170-1176. doi: 10.4244/EIJ-D-20-00187.
- Individual participant dataSharing planned: Undecided
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.
IRCCS Policlinico San Donato
San Donato Milanese, Italy
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 Clopidogrel, Poor Metabolism of and Carotid Stenosis, run by IRCCS Policlinico S. Donato 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 2 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 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: 1 month). The study lists 6 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 NCT05566301, which also lists 6 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 2 Jul 2026.