Acute Coronary SyndromePhase 4TACSINCT03560310
Ticagrelor and ASA vs. ASA Only After Isolated Coronary Artery Bypass Grafting in Patients With Acute Coronary Syndrome
A Phase 4 study testing Ticagrelor 90mg twice daily and ASA 75-100 mg daily and ASA 75-160 mg daily in people with Acute Coronary Syndrome, run by Vastra Gotaland Region at 22 sites in 5 countries.
Trial summary
The study is a Randomised Registry-based Clinical Trial (RRCT) to assess whether dual antiplatelet therapy with ticagrelor and ASA compared to ASA alone improves outcome after isolated CABG in patients with acute coronary syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Ticagrelor 90mg twice daily and ASA 75-100 mg daily and ASA 75-160 mg daily
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,201 participants
- Where
- 22 sitesin 5 countries
- Study dates
- 29 Jun 2018to 15 Feb 2035
- Phase
- Phase 4
- 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
- Written informed consent
- Age ≥18 years
- Has undergone first time isolated CABG due to an episode of acute coronary syndrome (STEMI, NSTEMI, unstable angina) within 6 weeks before surgery
Who cannot join
- Previously enrolled in this study (i.e. patient now at repeat encounter)
- Concomitant surgical procedure other than CABG
- Anticoagulant treatment after the operation (e.g. warfarin, direct thrombin inhibitors (dabigatran), FXa inhibitors (rivaroxaban, apixaban, heparin, low-molecular weight heparin, fondaparinux)
- Discharge from the operating hospital to an ICU at another hospital
- Pregnancy or lactation
- Known intolerance or contraindication to ticagrelor or ASA
Show all 17Show fewer
- Any disorder that may interfere with drug absorption
- Any condition other than coronary artery disease with a life expectancy <12 months
- Known chronic liver disease, renal disease requiring dialysis or bleeding disorder
- Atrioventricular block II and III in patients without pacemaker
- Any other indication for dual antiplatelet therapy, i.e. recent stent implantation
- Debilitating stroke within 90 days before inclusion
- Previous intracranial bleeding
- Treatment with immunosuppressants (e.g. cyclosporine and tacrolimus)
- Treatment with strong CYP3A4-inhibitors (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir or atazanavir)
- Any condition that in the opinion of the investigator may interfere with adherence to trial protocol
- Participation in any other clinical trial evaluating investigational products at the time for enrollment in this study
Trial locations and contacts
22 sites in 5 countries.
22 sites in 5 countries
Sweden8 sites
Sahlgrenska University Hospital
Gothenburg
Blekinge Hospital
Karlskrona
Linköping University Hospital
Linköping
Skåne University Hospital
Lund
Örebro University Hospital
Örebro
Karolinska University Hospital
Stockholm
University Hospital of Umeå
Umeå
Uppsala University Hospital
Uppsala
Finland5 sites
Helsinki University Hospital
Helsinki
Kuopio University Hospital
Kuopio
Oulu University Hospital
Oulu
Tampere University Hospital
Tampere
Turku University Hospital
Turku
Denmark4 sites
Aalborg University Hospital
Aalborg
Aarhus University Hospital
Aarhus
Rigshospitalet
Copenhagen
Odense University Hospital
Odense
Norway4 sites
St. Olavs hospital, University Hospital
Bergen
Oslo University Hospital
Oslo
University Hospital of North Norway
Tromsø
Haukeland University Hospital
Trondheim
About this study
Official title: Dual Antiplatelet Therapy With Ticagrelor and Acetylsalicylic Acid (ASA) vs. ASA Only After Isolated Coronary Artery Bypass Grafting in Patient With Acute Coronary Syndrome
The study is a Randomised Registry-based Clinical Trial (RRCT) to assess whether dual antiplatelet therapy with ticagrelor and ASA compared to ASA alone improves outcome after isolated CABG in patients with acute coronary syndrome.
Read the detailed description
The trial is a 1:1 randomized, interventional, multi-national, multi-center, safety/efficacy, parallel assignment, open-label treatment study and will use the RRCT methodology. A RRCT study utilizes existing health care registry platforms to conduct a pragmatic prospective randomized trial.
After the CABG, eligible patients that have consented to the study, will be randomized to either treatment arms. In the intervention arm, patients will be treated with ticagrelor 90 mg twice daily and ASA 75-100 mg daily for 12 months and patients in the control arm will get ASA only (75-160 mg daily according to local guidelines) during the same time period.
The patients will be followed by telephone interviews at 30 days and 365 days after inclusion. After the treatment period patients will be followed during an observation period by collection of outcome data from registries or medical records, 24, 36, 60 and 120 months after inclusion of the patient. No other data but the registry data or data from medical records will be collected.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Ticagrelor 90mg twice daily and ASA 75-100 mg daily, ASA 75-160 mg daily
- Keywords
- Coronary Bypass Grafting, Antiplatelet treatment
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ticagrelor 90mg twice daily and ASA 75-100 mg dailyDrug
Assess whether ticagrelor 90 mg twice daily and ASA 75-100 mg daily versus ASA 75-160 mg daily improves outcome after isolated coronary artery bypass grafting in patients with acute coronary syndrome
ASA 75-160 mg dailyDrug
Assess whether ticagrelor 90 mg twice daily and ASA 75-100 mg daily versus ASA 75-160 mg daily improves outcome after isolated coronary artery bypass grafting in patients with acute coronary syndrome
| Study group | Role | What they receive |
|---|---|---|
| Dual antiplatelet therapy | Experimental | Ticagrelor 90 mg twice daily and ASA 75-100 mg daily for 12 months Receives: Drug: Ticagrelor 90mg twice daily and ASA 75-100 mg daily |
| Acetylsalicylic acid | Active comparator | ASA 75-160 mg daily for 12 months Receives: Drug: ASA 75-160 mg daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to major adverse cardiovascular events (MACE)
To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone improves 12 months outcome defined as time to major adverse cardiovascular events (MACE) after isolated CABG in ACS patients. MACE includes all-cause mortality, myocardial infarction, stroke and new revascularization.
Measured: within12 months
Secondary outcomes (18)
Time to all cause death
To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences all cause death within 12 months after randomization
Measured: within 12 months
Time to all cause death, myocardial infarction or stroke
To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone improves 12 months outcome defined as time to a composite endpoint of all cause death, myocardial infarction or stroke after isolated CABG in ACS patients.
Measured: within 12 months
Time to cardiovascular death
To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences cardiovascular death within 12 months after randomization
Measured: within 12 months
Time to first myocardial infarction
To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences myocardial infarction within 12 months after randomization
Measured: within 12 months
Time to first stroke
To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of stroke within 12 months after randomization
Measured: within 12 months
Time to new revascularization
To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of new revascularization within 12 months after randomization
Measured: within 12 months
Time to coronary angiography
To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of coronary angiography within 12 months after randomization
Measured: within 12 months
Time to hospitalization for heart failure
To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of heart failure within 12 months after randomization
Measured: within 12 months
Time to cardiovascular hospitalization
To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of cardiovascular hospitalization within 12 months after randomization
Measured: within 12 months
Time to sudden death or aborted cardiac arrest
To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of sudden death or aborted cardiac arrest within 12 months after randomization
Measured: within 12 months
Time to new-onset atrial fibrillation
To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of new-onset atrial fibrillation within 12 months after randomization
Measured: within 12 months
Time to major bleeding defined as bleeding requiring hospitalization
To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of major bleeding within 12 months after randomization
Measured: within 12 months
Time to minor bleeding
To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of minor bleeding within 12 months after randomization
Measured: within 12 months
Time to any bleeding
To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of any bleeding within 12 months after randomization
Measured: within 12 months
Time to dyspnea
To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of dyspnea within 12 months after randomization
Measured: within 12 months
Time to dyspnea causing drug interruption
To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of dyspnea causing drug interruption within 12 months after randomization
Measured: within 12 months
Time to new onset renal failure
To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone influences the incidence of new onset renal failure within 12 months after randomization
Measured: within 12 months
Time to major adverse cardiovascular events (MACE)
To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone improves long-term outcome defined as time to major adverse cardiovascular events (MACE) after isolated CABG in ACS patients. MACE includes all-cause mortality, myocardial infarction, stroke and new revascularization.
Measured: 2, 3, 5 and 10 years after the patient has been included in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start29 Jun 2018
- Primary completion13 Mar 2025
- Study completion15 Feb 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel treatment arms.
- Masking
- None (open label)
- Enrolment
- 2,201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Gothia Forum - Center for Clinical Trial, Göteborg University
- Responsible party
- Sponsor
- Investigators
- Anders Jeppssson, MD,PhD,Prof., Principal investigator, Dep. of Cardiothoracic Surgery , Sahlgrenska University Hospital, 413 45 Gothenburg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03560310
- Sponsor's protocol ID
- EudraCT 2017-001499-43
- Acronym
- TACSI
- Status last verified
- Aug 2025
- First submitted
- 1 Jun 2018
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jeppsson A, James S, Moller CH, Malm CJ, Dalen M, Vanky F, Modrau IS, Andersen K, Anttila V, Atroshchenko GV, Barbu M, Dreifaldt M, El-Akkawi AI, Friberg O, Gudbjartsson T, Gunn J, Haaverstad R, Halonen J, Hansson EC, Holm J, Husso A, Juvonen T, Jakobsen O, Jideus L, Johannesson E, Jonsson Holmdahl A, Jonsson K, Kolseth SM, Krasniqi L, Makela T, Mennander A, Mohagen Krogstad LE, Rafiq S, Raivio P, Riber L, Tahir A, Thorsen C, Tonnessen T, Wahba A, Zindovic I, Pivodic A, Nielsen SJ, Erlinge D, Alfredsson J, Sartipy U; TACSI Trial Group.; TACSI Trial Group. Ticagrelor and Aspirin or Aspirin Alone after Coronary Surgery for Acute Coronary Syndrome. N Engl J Med. 2025 Dec 11;393(23):2313-2323. doi: 10.1056/NEJMoa2508026. Epub 2025 Sep 1.
PubMed 40888737Malm CJ, Alfredsson J, Erlinge D, Gudbjartsson T, Gunn J, James S, Moller CH, Nielsen SJ, Sartipy U, Tonnessen T, Jeppsson A. Dual or single antiplatelet therapy after coronary surgery for acute coronary syndrome (TACSI trial): Rationale and design of an investigator-initiated, prospective, multinational, registry-based randomized clinical trial. Am Heart J. 2023 May;259:1-8. doi: 10.1016/j.ahj.2023.01.011. Epub 2023 Jan 18.
PubMed 36681173
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Antiplatelet Therapy With Ticagrelor and Acetylsalicylic Acid (ASA) vs. ASA Only After Isolated Coronary Artery Bypass Grafting in Patient With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT03560310
- Acronym / sponsor ID
- TACSI / EudraCT 2017-001499-43
- Conditions
- Acute Coronary Syndrome
- Keywords
- Coronary Bypass Grafting, Antiplatelet treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,201 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Gothia Forum - Center for Clinical Trial, Göteborg University
- Study start
- 29 Jun 2018 (actual)
- Primary completion
- 13 Mar 2025 (actual)
- Study completion
- 15 Feb 2035 (estimated)
- First posted
- 18 Jun 2018 (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 is a Randomised Registry-based Clinical Trial (RRCT) to assess whether dual antiplatelet therapy with ticagrelor and ASA compared to ASA alone improves outcome after isolated CABG in patients with acute coronary syndrome.
Detailed description
The trial is a 1:1 randomized, interventional, multi-national, multi-center, safety/efficacy, parallel assignment, open-label treatment study and will use the RRCT methodology. A RRCT study utilizes existing health care registry platforms to conduct a pragmatic prospective randomized trial.
After the CABG, eligible patients that have consented to the study, will be randomized to either treatment arms. In the intervention arm, patients will be treated with ticagrelor 90 mg twice daily and ASA 75-100 mg daily for 12 months and patients in the control arm will get ASA only (75-160 mg daily according to local guidelines) during the same time period.
The patients will be followed by telephone interviews at 30 days and 365 days after inclusion. After the treatment period patients will be followed during an observation period by collection of outcome data from registries or medical records, 24, 36, 60 and 120 months after inclusion of the patient. No other data but the registry data or data from medical records will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel treatment arms.
| Arm | Type | Receives |
|---|---|---|
| Dual antiplatelet therapy | Experimental | Drug: Ticagrelor 90mg twice daily and ASA 75-100 mg dailyTicagrelor 90 mg twice daily and ASA 75-100 mg daily for 12 months |
| Acetylsalicylic acid | Active comparator | Drug: ASA 75-160 mg dailyASA 75-160 mg daily for 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent
- Age ≥18 years
- Has undergone first time isolated CABG due to an episode of acute coronary syndrome (STEMI, NSTEMI, unstable angina) within 6 weeks before surgery
Key exclusion criteria (17 listed)
- Previously enrolled in this study (i.e. patient now at repeat encounter)
- Concomitant surgical procedure other than CABG
- Anticoagulant treatment after the operation (e.g. warfarin, direct thrombin inhibitors (dabigatran), FXa inhibitors (rivaroxaban, apixaban, heparin, low-molecular weight heparin, fondaparinux)
- Discharge from the operating hospital to an ICU at another hospital
- Pregnancy or lactation
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 |
|---|---|---|
| Ticagrelor 90mg twice daily and ASA 75-100 mg dailyAssess whether ticagrelor 90 mg twice daily and ASA 75-100 mg daily versus ASA 75-160 mg daily improves outcome after isolated coronary artery bypass grafting in patients with acute coronary syndrome | Drug | Dual antiplatelet therapy |
| ASA 75-160 mg dailyAssess whether ticagrelor 90 mg twice daily and ASA 75-100 mg daily versus ASA 75-160 mg daily improves outcome after isolated coronary artery bypass grafting in patients with acute coronary syndrome | Drug | Acetylsalicylic acid |
Primary outcome
Time to major adverse cardiovascular events (MACE)
Time frame: within12 months
To assess whether dual antiplatelet therapy (DAPT) with ticagrelor and ASA compared to single antiplatelet therapy with ASA alone improves 12 months outcome defined as time to major adverse cardiovascular events (MACE) after isolated CABG in ACS patients. MACE includes all-cause mortality, myocardial infarction, stroke and new revascularization.
18 secondary outcomes
Time to all cause death
Time frame: within 12 months
Time to all cause death, myocardial infarction or stroke
Time frame: within 12 months
Time to cardiovascular death
Time frame: within 12 months
Time to first myocardial infarction
Time frame: within 12 months
Time to first stroke
Time frame: within 12 months
Time to new revascularization
Time frame: within 12 months
Time to coronary angiography
Time frame: within 12 months
Time to hospitalization for heart failure
Time frame: within 12 months
Time to cardiovascular hospitalization
Time frame: within 12 months
Time to sudden death or aborted cardiac arrest
Time frame: within 12 months
Time to new-onset atrial fibrillation
Time frame: within 12 months
Time to major bleeding defined as bleeding requiring hospitalization
Time frame: within 12 months
Time to minor bleeding
Time frame: within 12 months
Time to any bleeding
Time frame: within 12 months
Time to dyspnea
Time frame: within 12 months
Time to dyspnea causing drug interruption
Time frame: within 12 months
Time to new onset renal failure
Time frame: within 12 months
Time to major adverse cardiovascular events (MACE)
Time frame: 2, 3, 5 and 10 years after the patient has been included in the study
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 Sep 2025.
- Derived from this study: PubMed 40888737Jeppsson A, James S, Moller CH, Malm CJ, Dalen M, Vanky F, Modrau IS, Andersen K, Anttila V, Atroshchenko GV, Barbu M, Dreifaldt M, El-Akkawi AI, Friberg O, Gudbjartsson T, Gunn J, Haaverstad R, Halonen J, Hansson EC, Holm J, Husso A, Juvonen T, Jakobsen O, Jideus L, Johannesson E, Jonsson Holmdahl A, Jonsson K, Kolseth SM, Krasniqi L, Makela T, Mennander A, Mohagen Krogstad LE, Rafiq S, Raivio P, Riber L, Tahir A, Thorsen C, Tonnessen T, Wahba A, Zindovic I, Pivodic A, Nielsen SJ, Erlinge D, Alfredsson J, Sartipy U; TACSI Trial Group.; TACSI Trial Group. Ticagrelor and Aspirin or Aspirin Alone after Coronary Surgery for Acute Coronary Syndrome. N Engl J Med. 2025 Dec 11;393(23):2313-2323. doi: 10.1056/NEJMoa2508026. Epub 2025 Sep 1.
- Derived from this study: PubMed 36681173Malm CJ, Alfredsson J, Erlinge D, Gudbjartsson T, Gunn J, James S, Moller CH, Nielsen SJ, Sartipy U, Tonnessen T, Jeppsson A. Dual or single antiplatelet therapy after coronary surgery for acute coronary syndrome (TACSI trial): Rationale and design of an investigator-initiated, prospective, multinational, registry-based randomized clinical trial. Am Heart J. 2023 May;259:1-8. doi: 10.1016/j.ahj.2023.01.011. Epub 2023 Jan 18.
- 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. This study is not recruiting at the moment.
Anders Jeppssson, MD,PhD,Prof. principal investigator
Dep. of Cardiothoracic Surgery , Sahlgrenska University Hospital, 413 45 Gothenburg, Sweden
22 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ticagrelor 90mg twice daily and ASA 75-100 mg daily and ASA 75-160 mg daily in people with Acute Coronary Syndrome, run by Vastra Gotaland Region at 22 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Sweden, Finland, Denmark, Norway, Iceland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Time to major adverse cardiovascular events (MACE) (time frame: within12 months). 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 NCT03560310, which also lists 2 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 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.