Non ST Segment Elevation Acute Coronary SyndromeARTICA-2NCT07252245
Pre Hospital Triage of Patients at Intermediate and High Risk for ACS
A study testing Integrating the HEAR score and hs POC troponin into pre hospital triage decision-making: in people with Non ST Segment Elevation Acute Coronary Syndrome, run by Cyril Camaro at 3 sites in Netherlands.
Trial summary
RESEARCH QUESTION: Is a treatment strategy that includes direct referral to a PCI center for intermediate to high-risk patients with non-ST elevation acute coronary syndrome (NSTE-ACS), both cost-effective and non-inferior for major adverse cardiac events (MACE)? HYPOTHESIS: Prehospital triage with the modified… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non ST Segment Elevation Acute Coronary Syndrome
- What is being tested?
- Integrating the HEAR score and hs POC troponin into pre hospital triage decision-making:
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,048 participants
- Where
- 3 sitesNetherlands
- Study dates
- 4 Sep 2026to 1 Feb 2030
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥ 18 years
- All out-of-hospital patients with chest pain or symptoms suggestive of ACS with an indication for transfer to the (cardiac) emergency department to evaluate and rule out ACS
- Modified HEAR(T) score ≥ 4
- The patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Who cannot join
- Electrocardiographic ST-segment elevation (STEMI)
- Patients with confirmed myocardial infarction, PCI or CABG <14 days prior to inclu-sion
- Patients presenting an obvious non-cardiac cause for the chest complaints who need evaluation at an emergency department, e.g. trauma, pneumothorax, sepsis, etc.
- Patients in comatose state, defined as an EMV <8
- Patients with known cognitive impairment
- Pregnancy
Show all 16Show fewer
- Patients presenting with cardiogenic shock, defined as: systolic blood pressure <90mmHg and heart rate >100 and peripheral oxygen saturation <90% (without oxygen administration)
- Patients presenting with syncope
- Patients presenting with signs of heart failure
- Patients presenting with second or third degree atrioventricular block
- Patients without known supraventricular tachycardia i.e. unknown atrial fibrillation (known atrial fibrillation with adequate rate control can be included)
- Patients with known end-stage renal disease (dialysis and/or GFR < 30 ml/min)
- Patients without a pre-hospital 12-lead ECG performed or available
- Patients suspicious of aortic dissection or pulmonary embolism
- Communication issues with patient/language barrier
- Any significant medical or mental condition, which in the Investigator's opinion may interfere with the patient's optimal participation in the study
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands3 sites, 3 recruiting
- Recruiting
RAV Brabant midden-west-noord: post Haps
Haps
Risco van Vliet, Msc, +3185 044 22 00, info@ravbrabantmwn.nl
- Recruiting
Radboudumc Nijmegen, The Netherlands
Nijmegen, 6525 GA
Anja Bekkers, MD, +31650008480, articastudie.cardio@radboudumc.nl
Cyril Camaro, MD, +31243616785, cyril.camaro@radboudumc.nl
- Not yet recruiting
Veiligheidsregio Gelderland-Zuid
Nijmegen
Adriaan Penson, PhD, +3188 457 50 00, info@vrgz.nl
About this study
Official title: Pre Hospital Triage of Patients at Intermediate and High Risk for ACS: ARTICA-2 Trial
RESEARCH QUESTION: Is a treatment strategy that includes direct referral to a PCI center for intermediate to high-risk patients with non-ST elevation acute coronary syndrome (NSTE-ACS), both cost-effective and non-inferior for major adverse cardiac events (MACE)? HYPOTHESIS: Prehospital triage with the modified [History-ECG-Age-Risk factors] (HEAR) score and a high sensitivity (hs) point-of-care troponin (POCT) leads to a faster diagnosis of ACS, faster time to coronary angiography (CAG) and/or treatment with PCI, shorter length of stay, quicker availability of ambulances and more satisfaction and quality of life of patients. STUDY DESIGN: Randomized clinical trial. STUDY POPULATION: Patients ≥18 years with an intermediate to high risk for NSTE -ACS (defined as a modified HEAR score ≥ 4) INTERVENTION: applying modified HEAR score and hs POCT to identify patients for direct rule out (very low risk), transfer to the nearest hospital for rapid rule-out and/or fast-track diagnosis by CT coronary imaging (intermediate risk) or direct referral to a PCI center for CAG (high risk).
USUAL CARE/COMPARISON: Assessment of ACS at the nearest hospital. In case PCI is scheduled: transfer to nearest PCI center.
Read more
OUTCOME MEASURES: primary endpoints: healthcare costs and non-inferiority for MACE (all cause death, confirmed ACS, re ACS, and unplanned PCI or CABG) at 30 days. Secondary: MACE after rule out ACS at 30 days, Quality of life (EQ5D5L) and cost-effectiveness at 12 months.
SAMPLE SIZE: 1048 patients. COST-EFFECTIVENESS ANALYSIS / BIA: It is expected that the intervention group will reduce healthcare costs and potentially improve health-related quality of life in this target population. Cost-effectiveness will be expressed as cost per QALY gained. We assume a large potential saving more than € 37 million if 100% implemented. TIME SCHEDULE: 48 months; 36 month inclusion, follow-up 12 months
Read the detailed description
Rationale: Each year, 335.000 patients in the Netherlands seek medical attention for acute chest pain. The majority of these patients (67%) are at intermediate to high risk of developing non-ST elevation acute coronary syndrome (NSTE-ACS). Immediate ambulance transport to the nearest emergency department (ED) remains the standard of care. The availability of clinical decision rules, along with new high-sensitivity (hs) POC troponin analyzers, presents new opportunities for the early identification of higher-risk patients, potentially improving healthcare logistic. Currently, only observational data are available regarding these groups. Randomized clinical trials (RCT) on a prehospital strategy that includes a rapid rule out or fast-track diagnosis care path for the intermediate risk group or direct referral to a PCI center for the higher risk group has not been studied in a RCT before. More data are needed on prehospital strategies in high-risk groups, focusing on costs and major adverse cardiac events (MACE).
Objective: To assess healthcare costs and safety (MACE) at 30 days of an integrated pre-hospital triage strategy using the [History-ECG-Age-Risk factors] HEAR score and hs POC troponin for patients at intermediate to high risk of NSTE ACS. Secondary objective includes MACE after rule-out ACS at 30 days and cost-effectiveness and quality of life at 12 months.
Study design: Randomized clinical trial (pragmatic strategy trial) Sample size calculation: 1048 patients. A MACE rate of 20% for all risk groups in both the standard and intervention groups: sample sizes of 476 per group to achieve 80% power to detect a non-inferiority margin of 0.0800. The reference group proportion is 0.2000, and the treatment group proportion is 0.2800 under the null hypothesis of inferiority. Power was calculated assuming the actual treatment group proportion is 0.2 Study population: Patients ≥18 years with an intermediate to high risk for NSTE-ACS (defined as a modified HEAR score ≥ 4) Intervention: applying modified HEAR score and hs POC troponin to identify patients for direct rule out (low risk), transfer to the nearest hospital for rapid rule-out and/or fast-track diagnosis in which non-invasive imaging is strongly recommended (intermediate risk) or direct referral to a PCI center (high risk).
Main study parameters/endpoints: primary endpoints: healthcare costs and non-inferiority for MACE (all cause death, confirmed ACS, re ACS, and unplanned PCI or CABG) at 30 days. Secondary: MACE after ruling out ACS at 30 days, Quality of life (EQ5D5L) and cost-effectiveness at 12 months.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Two-thirds of ACS patients are intermediate to high risk and standard hospital evaluation remain the standard of care. In this study the randomized group will receive a patient tailored prehospital management (conservative, local hospital with non-invasive imaging testing, or direct PCI referral). This strategy may safely reduce unnecessary hospitalizations, costs and efficient hospital transfers. While increasing the time to diagnosis of NSTE ACS
- Being tested
- Integrating the HEAR score and hs POC troponin into pre hospital triage decision-making:
- Keywords
- HEART score, NSTE-ACS, Pre-hospital triage, high risk ACS, intermediate risk ACS, point-of-care troponin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrating the HEAR score and hs POC troponin into pre hospital triage decision-making:Other
Integrating the HEAR score and hs POC troponin into pre hospital triage decision-making: low risk (HEAR score 4 and hs POC troponin < 99th percentile upper reference limit (URL)) will be treated conservatively (i.e. referred to the general practitioner); intermediate risk (HEAR score 4 and onset symptoms < 1 hour ago, HEAR score ≥5 and hs POC troponin < 99th percentile URL or HEAR score 4-6 with intermediate elevated hs POC troponin (i.e. hs POC troponin between 1 and 3 times the 99th percentile URL) are admitted to the nearest hospital with a rapid rule out strategy or recommendation for fast-track coronary CT imaging (CTCA); high risk group (HEAR ≥ 7 ánd hs POC troponin > 99th percentile URL or any HEAR score with hs POC troponin 3x > 99th URL will be directly referred to a PCI center
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Integrating the HEAR score and hs POC troponin into pre hospital triage decision-making: Receives: Other: Integrating the HEAR score and hs POC troponin into pre hospital triage decision-making: |
| Standard care group | No intervention | intermediate and high risk patients referred to the nearest hospital for standard care. The ACS rule-out protocol follows the 2023 Guidelines of the European Society of Cardiology (ESC). In confirmed cases of ACS, patients should be scheduled for invasive coronary angiography within the recommended time window as outlined by the ESC guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority for MACE
MACE (% all cause death, confirmed ACS, re ACS, and unplanned PCI or CABG). Risk differences will be calculated along with 95% confidence intervals
Measured: from enrollment to end of treatment at 30 days and 12 months
Healthcare costs
healthcare costs in EURO
Measured: from enrollment to end of treatment at 30 days and 12 months
Secondary outcomes (3)
MACE after ruling out ACS
30-day incidence of MACE in %. Risk differences will be calculated along with 95% confidence intervals
Measured: from enrollment to end of treatment at 30 days
Quality of life measured with the EQ5D5L
Quality of life
Measured: from enrollment to end of treatment at 30 days and 12 months
Cost-effectiveness analysis (CEA)
Incremental cost-effectiveness ratios (ICERs) will be calculated
Measured: from enrollment to end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start4 Sep 2026
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non ST Segment Elevation Acute Coronary SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Strategy study: A) intervention group: Integrating the HEAR score and hs POC troponin: pre- hospital triage decision-making for intermediate and high risk patients: B) Standard care group: all intermediate and high risk patients are referred to the nearest hospital to rule-out or rule-in ACS
- Masking
- None (open label)
- Enrolment
- 1,048 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cyril Camaro
- Sponsor type
- University, hospital or other
- Collaborators
- Canisius-Wilhelmina Hospital, Slingeland Hospital, Maas Hospital Pantein, Rijnstate Hospital, RAV Brabant MWN, Ambulance services Veiligheidsregio Gelderland-Zuid
- Responsible party
- Sponsor-investigator, Cyril Camaro, Radboud University Medical Center
- Investigators
- Cyril Camaro, MD, Principal investigator, Radboudumc / department Cardiology 616
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252245
- Sponsor's protocol ID
- NL-010807
- Other IDs
- 10390042410064
- Acronym
- ARTICA-2
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is anticipated that individual participant data (IPD) will be made available. A detailed and comprehensive data sharing strategy will be established in 2026
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre Hospital Triage of Patients at Intermediate and High Risk for ACS: ARTICA-2 Trial
- ClinicalTrials.gov ID
- NCT07252245
- Acronym / sponsor ID
- ARTICA-2 / NL-010807
- Keywords
- HEART score, NSTE-ACS, Pre-hospital triage, high risk ACS, intermediate risk ACS, point-of-care troponin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,048 participants (estimated)
- Lead sponsor
- Cyril CamaroUniversity, hospital or other
- Collaborators
- Canisius-Wilhelmina Hospital, Slingeland Hospital, Maas Hospital Pantein, Rijnstate Hospital, RAV Brabant MWN, Ambulance services Veiligheidsregio Gelderland-Zuid
- Study start
- 4 Sep 2026 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Feb 2030 (estimated)
- First posted
- 26 Nov 2025 (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.
RESEARCH QUESTION: Is a treatment strategy that includes direct referral to a PCI center for intermediate to high-risk patients with non-ST elevation acute coronary syndrome (NSTE-ACS), both cost-effective and non-inferior for major adverse cardiac events (MACE)? HYPOTHESIS: Prehospital triage with the modified [History-ECG-Age-Risk factors] (HEAR) score and a high sensitivity (hs) point-of-care troponin (POCT) leads to a faster diagnosis of ACS, faster time to coronary angiography (CAG) and/or treatment with PCI, shorter length of stay, quicker availability of ambulances and more satisfaction and quality of life of patients. STUDY DESIGN: Randomized clinical trial. STUDY POPULATION: Patients ≥18 years with an intermediate to high risk for NSTE -ACS (defined as a modified HEAR score ≥ 4) INTERVENTION: applying modified HEAR score and hs POCT to identify patients for direct rule out (very low risk), transfer to the nearest hospital for rapid rule-out and/or fast-track diagnosis by CT coronary imaging (intermediate risk) or direct referral to a PCI center for CAG (high risk).
USUAL CARE/COMPARISON: Assessment of ACS at the nearest hospital. In case PCI is scheduled: transfer to nearest PCI center.
OUTCOME MEASURES: primary endpoints: healthcare costs and non-inferiority for MACE (all cause death, confirmed ACS, re ACS, and unplanned PCI or CABG) at 30 days. Secondary: MACE after rule out ACS at 30 days, Quality of life (EQ5D5L) and cost-effectiveness at 12 months.
SAMPLE SIZE: 1048 patients. COST-EFFECTIVENESS ANALYSIS / BIA: It is expected that the intervention group will reduce healthcare costs and potentially improve health-related quality of life in this target population. Cost-effectiveness will be expressed as cost per QALY gained. We assume a large potential saving more than € 37 million if 100% implemented. TIME SCHEDULE: 48 months; 36 month inclusion, follow-up 12 months
Detailed description
Rationale: Each year, 335.000 patients in the Netherlands seek medical attention for acute chest pain. The majority of these patients (67%) are at intermediate to high risk of developing non-ST elevation acute coronary syndrome (NSTE-ACS). Immediate ambulance transport to the nearest emergency department (ED) remains the standard of care. The availability of clinical decision rules, along with new high-sensitivity (hs) POC troponin analyzers, presents new opportunities for the early identification of higher-risk patients, potentially improving healthcare logistic. Currently, only observational data are available regarding these groups. Randomized clinical trials (RCT) on a prehospital strategy that includes a rapid rule out or fast-track diagnosis care path for the intermediate risk group or direct referral to a PCI center for the higher risk group has not been studied in a RCT before. More data are needed on prehospital strategies in high-risk groups, focusing on costs and major adverse cardiac events (MACE).
Objective: To assess healthcare costs and safety (MACE) at 30 days of an integrated pre-hospital triage strategy using the [History-ECG-Age-Risk factors] HEAR score and hs POC troponin for patients at intermediate to high risk of NSTE ACS. Secondary objective includes MACE after rule-out ACS at 30 days and cost-effectiveness and quality of life at 12 months.
Study design: Randomized clinical trial (pragmatic strategy trial) Sample size calculation: 1048 patients. A MACE rate of 20% for all risk groups in both the standard and intervention groups: sample sizes of 476 per group to achieve 80% power to detect a non-inferiority margin of 0.0800. The reference group proportion is 0.2000, and the treatment group proportion is 0.2800 under the null hypothesis of inferiority. Power was calculated assuming the actual treatment group proportion is 0.2 Study population: Patients ≥18 years with an intermediate to high risk for NSTE-ACS (defined as a modified HEAR score ≥ 4) Intervention: applying modified HEAR score and hs POC troponin to identify patients for direct rule out (low risk), transfer to the nearest hospital for rapid rule-out and/or fast-track diagnosis in which non-invasive imaging is strongly recommended (intermediate risk) or direct referral to a PCI center (high risk).
Main study parameters/endpoints: primary endpoints: healthcare costs and non-inferiority for MACE (all cause death, confirmed ACS, re ACS, and unplanned PCI or CABG) at 30 days. Secondary: MACE after ruling out ACS at 30 days, Quality of life (EQ5D5L) and cost-effectiveness at 12 months.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Two-thirds of ACS patients are intermediate to high risk and standard hospital evaluation remain the standard of care. In this study the randomized group will receive a patient tailored prehospital management (conservative, local hospital with non-invasive imaging testing, or direct PCI referral). This strategy may safely reduce unnecessary hospitalizations, costs and efficient hospital transfers. While increasing the time to diagnosis of NSTE ACS
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Strategy study: A) intervention group: Integrating the HEAR score and hs POC troponin: pre- hospital triage decision-making for intermediate and high risk patients: B) Standard care group: all intermediate and high risk patients are referred to the nearest hospital to rule-out or rule-in ACS
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Other: Integrating the HEAR score and hs POC troponin into pre hospital triage decision-making:Integrating the HEAR score and hs POC troponin into pre hospital triage decision-making: |
| Standard care group | No intervention | –intermediate and high risk patients referred to the nearest hospital for standard care. The ACS rule-out protocol follows the 2023 Guidelines of the European Society of Cardiology (ESC). In confirmed cases of ACS, patients should be scheduled for invasive coronary angiography within the recommended time window as outlined by the ESC guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- All out-of-hospital patients with chest pain or symptoms suggestive of ACS with an indication for transfer to the (cardiac) emergency department to evaluate and rule out ACS
- Modified HEAR(T) score ≥ 4
- The patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Key exclusion criteria (16 listed)
- Electrocardiographic ST-segment elevation (STEMI)
- Patients with confirmed myocardial infarction, PCI or CABG <14 days prior to inclu-sion
- Patients presenting an obvious non-cardiac cause for the chest complaints who need evaluation at an emergency department, e.g. trauma, pneumothorax, sepsis, etc.
- Patients in comatose state, defined as an EMV <8
- Patients with known cognitive impairment
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 |
|---|---|---|
| Integrating the HEAR score and hs POC troponin into pre hospital triage decision-making:Integrating the HEAR score and hs POC troponin into pre hospital triage decision-making: low risk (HEAR score 4 and hs POC troponin < 99th percentile upper reference limit (URL)) will be treated conservatively (i.e. referred to the general practitioner); intermediate risk (HEAR score 4 and onset symptoms < 1 hour ago, HEAR score ≥5 and hs POC troponin < 99th percentile URL or HEAR score 4-6 with intermediate elevated hs POC troponin (i.e. hs POC troponin between 1 and 3 times the 99th percentile URL) are admitted to the nearest hospital with a rapid rule out strategy or recommendation for fast-track coronary CT imaging (CTCA); high risk group (HEAR ≥ 7 ánd hs POC troponin > 99th percentile URL or any HEAR score with hs POC troponin 3x > 99th URL will be directly referred to a PCI center | Other | Intervention group |
Primary outcome
Non-inferiority for MACE
Time frame: from enrollment to end of treatment at 30 days and 12 months
MACE (% all cause death, confirmed ACS, re ACS, and unplanned PCI or CABG). Risk differences will be calculated along with 95% confidence intervals
Healthcare costs
Time frame: from enrollment to end of treatment at 30 days and 12 months
healthcare costs in EURO
3 secondary outcomes
MACE after ruling out ACS
Time frame: from enrollment to end of treatment at 30 days
Quality of life measured with the EQ5D5L
Time frame: from enrollment to end of treatment at 30 days and 12 months
Cost-effectiveness analysis (CEA)
Time frame: from enrollment to end of treatment at 12 months
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 10 Sep 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. It is anticipated that individual participant data (IPD) will be made available. A detailed and comprehensive data sharing strategy will be established in 2026
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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.
Cyril Camaro, MD principal investigator
Radboudumc / department Cardiology 616
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrating the HEAR score and hs POC troponin into pre hospital triage decision-making: in people with Non ST Segment Elevation Acute Coronary Syndrome, run by Cyril Camaro at 3 sites in Netherlands.
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 16 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 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. 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 Cyril Camaro, MD (+31243616785, articastudie.cardio@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-inferiority for MACE (time frame: from enrollment to end of treatment at 30 days and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2026.