Atrial FibrillationORIGAMI IINCT06285942
EdOxaban in fRagIle Patients With Percutaneous Endoscopic GAstrostoMy and atrIal fIbrIllation
A study testing Edoxaban and No Edoxaban in people with Atrial Fibrillation and Fragility, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 3 sites in Italy.
Trial summary
The goal of this interventional study is to describe the use of Edoxaban via PEG in patients with an indication to anticoagulation therapy. One arm will receive Edoxaban through PEG and the other arm will receive other Direct oral anticoagulants through PEG or subcutaneous heparin or LMWH. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Fragility
- What is being tested?
- Edoxaban and No Edoxaban
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 3 sitesItaly
- Study dates
- 1 Feb 2024to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PEG (recent implantation or already present)
- Indication for long-term oral anticoagulation
Who cannot join
- Under 18 years of age
- Life expectancy <30 days
- Lack of informed consent
- Contraindication to DOACs
Trial locations and contacts
3 sites in 1 country.
Italy3 sites, 3 recruiting
- Recruiting
Ospedale Policlinico San Martino
Genova, 16132
Pietro Ameri, Prof, +39 010 3538975, pietro.ameri@unige.it
- Recruiting
AOU Maggiore della Carità
Novara, 28100
Domenico D'Amario, Prof, 0039 0321 3733141, domenico.damario@uniupo.it
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
Cristiano Spada, Prof, 06 30151, cristiano.spada@policlinicogemelli.it
About this study
Official title: EdOxaban in fRagIle Patients With Percutaneous Endoscopic GAstrostoMy and atrIal fIbrIllation: the ORIGAMI II Study
The goal of this interventional study is to describe the use of Edoxaban via PEG in patients with an indication to anticoagulation therapy. One arm will receive Edoxaban through PEG and the other arm will receive other Direct oral anticoagulants through PEG or subcutaneous heparin or LMWH.
Once enrolled, patients will be treated with a single daily dose of Edoxaban (60 or 30 mg according to specific indications). At day 4 after enrollment (steady state), evaluation of anti-FXa activity and thrombin generation assay will be performed on peripheral whole blood samples. At months 6 and 12 patients will be asked to complete the ACTS (Anti-Clot treatment scale) questionnaire specific for anticoagulation.
The main endpoint will be: the difference in the results of the Anti-Clot treatment scale questionnaire between the two groups evaluated at 12 months.
Read the detailed description
Direct oral anticoagulants (DOAC) have a remarkable efficacy/safety ratio, a predictable anticoagulant effect and are recommended by ESC guidelines to be preferred over vitamin K antagonist (VKA) wherever possible in the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation. Enteral access feeding devices are placed in patients who have a functional and accessible gastrointestinal tract but are not able to maintain an adequate oral intake. Among these devices, percutaneous endoscopic gastrostomy (PEG) represents a valid option, especially for long-term feeding, and PEG positioning has shown a steadily increasing trend in fragile patients with several comorbidities.
A significant subgroup of subjects with PEG tube has an indication to long-term anticoagulant therapy, mainly represented by atrial fibrillation. Among the several pharmacodynamic pathway mediating anticoagulation, direct FXa inhibitors block both free FXa and FXa bound to form the prothrombinase complex, whereas the indirect FXa inhibitors, such as LMHW, only inhibit free FXa. It was recently described a safe and effective anticoagulation through the administration of edoxaban 30 mg daily (crushed and diluted in 10 mL of saline solution) through a PEG in a patient with advanced amyotrophic lateral sclerosis, tracheostomy, atrial fibrillation, and a recent acute heart failure. On these premises, the investigators designed the ORal anti-coagulants In fraGile patients with percutAneous endoscopic gastrostoMy and atrIal fibrillation (ORIGAMI) pilot investigation, evaluating the feasibility, anticoagulant effectiveness and preliminary safety and efficacy of edoxaban administration via PEG in fragile patients with NVAF requiring long-term anticoagulation treatment.
The ORIGAMI II study will be a prospective, multi-centre, double arm, open label, clinical trial, aiming to describe the use of Edoxaban via PEG in patients with an indication to anticoagulation therapy according to current guidelines. One arm will receive Edoxaban through PEG and the other arm will receive other DOACs through PEG or subcutaneous heparin or LMWH.
The study will enroll 168 patients, who will be followed-up for 12 months. The Centers that will participate in this study will be: the AOU Maggiore della Carità of Novara (as coordinating center); Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma; Ospedale Policlinico San Martino, Genova.
The primary endpoint of this study is the difference in Anti-Clot treatment scale questionnaire results among the two groups assessed at 12 months.
- Conditions
- Atrial Fibrillation, Fragility
- Being tested
- Edoxaban, No Edoxaban
- Keywords
- Edoxaban, Fragile Patient, Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EdoxabanDrug
To use of Edoxaban via PEG in patients with an indication to anticoagulation therapy according to current guidelines
No EdoxabanDrug
Other DOACs through PEG or subcutaneous heparin or LMWH
| Study group | Role | What they receive |
|---|---|---|
| Edoxaban | Experimental | This arm will receive Edoxaban via PEG Receives: Drug: Edoxaban |
| No Edoxaban | Active comparator | This arm will receive other DOACs through PEG or subcutaneous heparin or LMWH Receives: Drug: No Edoxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Anti-Clot treatment scale (ACTS) questionnaire results among the two groups assessed at 6 and 12 months.
The Anti-Clot treatment scale (ACTS) is a 15-item patient-reported instrument of satisfaction with anticoagulant treatment. It includes a 12-item ACTS Burdens scale and a 3-item ACTS Benefits scale. The rate of experience of anticoagulant treatment during the past 4 weeks on a 5-point scale of intensity: 1 = not at all, 2 = a little, 3 = moderately, 4 = quite a bit, 5 = extremely.
Measured: at 6 and 12 months
Secondary outcomes (6)
Number of cardio-embolic events at 6 and12 months
The number of cardio-embolic events consisting of stroke, systemic embolism or symptomatic relapse of deep vein thrombosis/pulmonary embolism.
Measured: at 6 and 12 months
Number of bleeding events
The Bleeding Academic Research Consortium (BARC) scale and the Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria will be considered.
BARC scale from Type 1 (bleeding that is not actionable) to Type 5b (Fatal bleeding); TIMI bleeding criteria range from Minimal to Major, such as any intracranial bleeding, clinically evident signs of hemorrhage associated with a drop in hemoglobin ≥ 5 g/dl or fatal bleeding.
Measured: at 6 and 12 months
Assessment of drugs efficacy by measuring the anti-factor Xa activity
Mean DOACs plasma concentration-time profile will be measured at steady state as anti-FXa activity using the STA®-Liquid Anti-Xa assays on a STA Compact Max® instrument. The evaluation of the anti-FXa activity will be performed on peripheral whole blood samples.
Measured: at 6 and 12 months
Assessment of drugs efficacy by measuring the thrombin generation
At steady state will be measured the thrombin generation assay, both in patients receiving DOACs and in those receiving parenteral anticoagulation. The evaluation of the thrombin generation assay will be performed on peripheral whole blood samples.
Measured: at 6 and 12 months
Assess the quality of life
The Zarit Burden Interview (ZBI) will be used to assess quality of life. The ZBI is an interview to evaluate the consequences that the care burden of a family member with chronic or degenerative pathologies has on the caregiver, with a scale ranging from 0 with zero care load, to 88 with a maximum level of care load.
Measured: at 6 and 12 months
Cost-effectiveness analysis
A cost-effectiveness analysis will be carried out to compare the costs (direct and indirect) of treatment with Edoxaban compared to other subcutaneous anticoagulants.
Measured: at 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start1 Feb 2024
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Domenico D'Amario, Azienda Ospedaliero Universitaria Maggiore della Carita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285942
- Sponsor's protocol ID
- 277.535
- Other IDs
- CE366/2023
- Acronym
- ORIGAMI II
- Status last verified
- Feb 2024
- First submitted
- 15 Feb 2024
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Galli M, Andreotti F, Porto I, Crea F. Intracranial haemorrhages vs. stent thromboses with direct oral anticoagulant plus single antiplatelet agent or triple antithrombotic therapy: a meta-analysis of randomized trials in atrial fibrillation and percutaneous coronary intervention/acute coronary syndrome patients. Europace. 2020 Apr 1;22(4):538-546. doi: 10.1093/europace/euz345.
PubMed 31942971Galli M, Porto I, Andreotti F, D'Amario D, Vergallo R, Della Bona R, Crea F. Early anticoagulation in the current management of NSTE-ACS: Evidence, guidelines, practice and perspectives. Int J Cardiol. 2019 Jan 15;275:39-45. doi: 10.1016/j.ijcard.2018.10.087. Epub 2018 Oct 27.
PubMed 30391063Galli M, D'Amario D, Andreotti F, Porto I, Vergallo R, Sabatelli M, Lancellotti S, Meleo E, De Cristofaro R, Crea F. Sustained safe and effective anticoagulation using Edoxaban via percutaneous endoscopic gastrostomy. ESC Heart Fail. 2019 Aug;6(4):884-888. doi: 10.1002/ehf2.12434. Epub 2019 Jun 11.
PubMed 31184800D'Amario D, Galli M, Canonico F, Restivo A, Arcudi A, Scacciavillani R, Cappannoli L, Riccioni ME, Annetta MG, Di Stefano G, Piccinni C, Vergallo R, Montone RA, Leone AM, Niccoli G, Sabatelli M, Antonelli M, Andreotti F, De Cristofaro R, Crea F. ORal anticoagulants In fraGile patients with percutAneous endoscopic gastrostoMy and atrIal fibrillation: the (ORIGAMI) study. J Cardiovasc Med (Hagerstown). 2021 Mar 1;22(3):175-179. doi: 10.2459/JCM.0000000000001142.
PubMed 33186237D'Amario D, Galli M, Cappannoli L, Canonico F, Restivo A, Arcudi A, Scacciavillani R, Riccioni ME, Vergallo R, Montone RA, Conte A, Meleo E, Lancellotti S, Sacco M, Antonelli M, Andreotti F, DE Cristofaro R, Crea F. Oral anticoagulants in fragile patients with percutaneous endoscopic gastrostomy and atrial fibrillation: the ORIGAMI pilot investigation. Minerva Cardiol Angiol. 2023 Feb;71(1):109-116. doi: 10.23736/S2724-5683.21.05903-2. Epub 2022 Feb 15.
PubMed 35166091
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EdOxaban in fRagIle Patients With Percutaneous Endoscopic GAstrostoMy and atrIal fIbrIllation: the ORIGAMI II Study
- ClinicalTrials.gov ID
- NCT06285942
- Acronym / sponsor ID
- ORIGAMI II / 277.535
- Conditions
- Atrial Fibrillation, Fragility
- Keywords
- Edoxaban, Fragile Patient, Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della CaritaUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 29 Feb 2024 (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 goal of this interventional study is to describe the use of Edoxaban via PEG in patients with an indication to anticoagulation therapy. One arm will receive Edoxaban through PEG and the other arm will receive other Direct oral anticoagulants through PEG or subcutaneous heparin or LMWH.
Once enrolled, patients will be treated with a single daily dose of Edoxaban (60 or 30 mg according to specific indications). At day 4 after enrollment (steady state), evaluation of anti-FXa activity and thrombin generation assay will be performed on peripheral whole blood samples. At months 6 and 12 patients will be asked to complete the ACTS (Anti-Clot treatment scale) questionnaire specific for anticoagulation.
The main endpoint will be: the difference in the results of the Anti-Clot treatment scale questionnaire between the two groups evaluated at 12 months.
Detailed description
Direct oral anticoagulants (DOAC) have a remarkable efficacy/safety ratio, a predictable anticoagulant effect and are recommended by ESC guidelines to be preferred over vitamin K antagonist (VKA) wherever possible in the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation. Enteral access feeding devices are placed in patients who have a functional and accessible gastrointestinal tract but are not able to maintain an adequate oral intake. Among these devices, percutaneous endoscopic gastrostomy (PEG) represents a valid option, especially for long-term feeding, and PEG positioning has shown a steadily increasing trend in fragile patients with several comorbidities.
A significant subgroup of subjects with PEG tube has an indication to long-term anticoagulant therapy, mainly represented by atrial fibrillation. Among the several pharmacodynamic pathway mediating anticoagulation, direct FXa inhibitors block both free FXa and FXa bound to form the prothrombinase complex, whereas the indirect FXa inhibitors, such as LMHW, only inhibit free FXa. It was recently described a safe and effective anticoagulation through the administration of edoxaban 30 mg daily (crushed and diluted in 10 mL of saline solution) through a PEG in a patient with advanced amyotrophic lateral sclerosis, tracheostomy, atrial fibrillation, and a recent acute heart failure. On these premises, the investigators designed the ORal anti-coagulants In fraGile patients with percutAneous endoscopic gastrostoMy and atrIal fibrillation (ORIGAMI) pilot investigation, evaluating the feasibility, anticoagulant effectiveness and preliminary safety and efficacy of edoxaban administration via PEG in fragile patients with NVAF requiring long-term anticoagulation treatment.
The ORIGAMI II study will be a prospective, multi-centre, double arm, open label, clinical trial, aiming to describe the use of Edoxaban via PEG in patients with an indication to anticoagulation therapy according to current guidelines. One arm will receive Edoxaban through PEG and the other arm will receive other DOACs through PEG or subcutaneous heparin or LMWH.
The study will enroll 168 patients, who will be followed-up for 12 months. The Centers that will participate in this study will be: the AOU Maggiore della Carità of Novara (as coordinating center); Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma; Ospedale Policlinico San Martino, Genova.
The primary endpoint of this study is the difference in Anti-Clot treatment scale questionnaire results among the two groups assessed at 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Edoxaban | Experimental | Drug: EdoxabanThis arm will receive Edoxaban via PEG |
| No Edoxaban | Active comparator | Drug: No EdoxabanThis arm will receive other DOACs through PEG or subcutaneous heparin or LMWH |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- PEG (recent implantation or already present)
- Indication for long-term oral anticoagulation
Key exclusion criteria (4 listed)
- Under 18 years of age
- Life expectancy <30 days
- Lack of informed consent
- Contraindication to DOACs
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 |
|---|---|---|
| EdoxabanTo use of Edoxaban via PEG in patients with an indication to anticoagulation therapy according to current guidelines | Drug | Edoxaban |
| No EdoxabanOther DOACs through PEG or subcutaneous heparin or LMWH | Drug | No Edoxaban |
Primary outcome
Difference in Anti-Clot treatment scale (ACTS) questionnaire results among the two groups assessed at 6 and 12 months.
Time frame: at 6 and 12 months
The Anti-Clot treatment scale (ACTS) is a 15-item patient-reported instrument of satisfaction with anticoagulant treatment. It includes a 12-item ACTS Burdens scale and a 3-item ACTS Benefits scale. The rate of experience of anticoagulant treatment during the past 4 weeks on a 5-point scale of intensity: 1 = not at all, 2 = a little, 3 = moderately, 4 = quite a bit, 5 = extremely.
6 secondary outcomes
Number of cardio-embolic events at 6 and12 months
Time frame: at 6 and 12 months
Number of bleeding events
Time frame: at 6 and 12 months
Assessment of drugs efficacy by measuring the anti-factor Xa activity
Time frame: at 6 and 12 months
Assessment of drugs efficacy by measuring the thrombin generation
Time frame: at 6 and 12 months
Assess the quality of life
Time frame: at 6 and 12 months
Cost-effectiveness analysis
Time frame: at 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Background: PubMed 31942971Galli M, Andreotti F, Porto I, Crea F. Intracranial haemorrhages vs. stent thromboses with direct oral anticoagulant plus single antiplatelet agent or triple antithrombotic therapy: a meta-analysis of randomized trials in atrial fibrillation and percutaneous coronary intervention/acute coronary syndrome patients. Europace. 2020 Apr 1;22(4):538-546. doi: 10.1093/europace/euz345.
- Background: PubMed 30391063Galli M, Porto I, Andreotti F, D'Amario D, Vergallo R, Della Bona R, Crea F. Early anticoagulation in the current management of NSTE-ACS: Evidence, guidelines, practice and perspectives. Int J Cardiol. 2019 Jan 15;275:39-45. doi: 10.1016/j.ijcard.2018.10.087. Epub 2018 Oct 27.
- Background: PubMed 31184800Galli M, D'Amario D, Andreotti F, Porto I, Vergallo R, Sabatelli M, Lancellotti S, Meleo E, De Cristofaro R, Crea F. Sustained safe and effective anticoagulation using Edoxaban via percutaneous endoscopic gastrostomy. ESC Heart Fail. 2019 Aug;6(4):884-888. doi: 10.1002/ehf2.12434. Epub 2019 Jun 11.
- Background: PubMed 33186237D'Amario D, Galli M, Canonico F, Restivo A, Arcudi A, Scacciavillani R, Cappannoli L, Riccioni ME, Annetta MG, Di Stefano G, Piccinni C, Vergallo R, Montone RA, Leone AM, Niccoli G, Sabatelli M, Antonelli M, Andreotti F, De Cristofaro R, Crea F. ORal anticoagulants In fraGile patients with percutAneous endoscopic gastrostoMy and atrIal fibrillation: the (ORIGAMI) study. J Cardiovasc Med (Hagerstown). 2021 Mar 1;22(3):175-179. doi: 10.2459/JCM.0000000000001142.
- Background: PubMed 35166091D'Amario D, Galli M, Cappannoli L, Canonico F, Restivo A, Arcudi A, Scacciavillani R, Riccioni ME, Vergallo R, Montone RA, Conte A, Meleo E, Lancellotti S, Sacco M, Antonelli M, Andreotti F, DE Cristofaro R, Crea F. Oral anticoagulants in fragile patients with percutaneous endoscopic gastrostomy and atrial fibrillation: the ORIGAMI pilot investigation. Minerva Cardiol Angiol. 2023 Feb;71(1):109-116. doi: 10.23736/S2724-5683.21.05903-2. Epub 2022 Feb 15.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Edoxaban and No Edoxaban in people with Atrial Fibrillation and Fragility, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 3 sites 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: status not confirmed, as of the sponsor's last update on 29 Feb 2024. 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 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?
Results are not available in the source record.
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?
Difference in Anti-Clot treatment scale (ACTS) questionnaire results among the two groups assessed at 6 and 12 months. (time frame: at 6 and 12 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 NCT06285942, which also lists 5 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 29 Feb 2024.