Inflammatory ResponsePhase 3NCT06118034
Effect of Colchicine on Perioperative Anti-inflammatory Organ Injury in Cardiac Surgery
A Phase 3 study testing Colchicine 0.5 MG in people with Inflammatory Response and Cardiac Disease, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
All patients will be completed collection of demographic data, clinical data, and be observed for inflammatory organ damage, oxygenation index or SpO2/ FIO2, WBC, NEU, interleukin-1β, interleukin-6, interleukin-8 (IL-1β/6/8), tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), procalcitonin (PCT), myoglobin… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Inflammatory Response, Cardiac Disease
- What is being tested?
- Colchicine 0.5 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 768 participants
- Where
- 1 siteChina
- Study dates
- 28 Jan 2024to 30 Dec 2026
- Phase
- Phase 3
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 50 and 80 years, male or female;
- Patients undergoing elective cardiac surgery;
- Have signed the informed consent form (ICF).
Who cannot join
- Patients undergoing emergency surgery;
- Patients undergoing deep hypothermic circulatory arrest surgery;
- Preoperative predicted mortality >3% according to European System for Cardiac Operative Risk Evaluation II (EuroSCORE II);
- Patients undergoing off-pump coronary artery bypass grafting (off-pump CABG) surgery;
- Patients undergoing left or right ventricular outflow tract obstruction surgery;
- Patients undergoing complex corrective surgery for congenital heart disease;
Show all 23Show fewer
- Patients with an expected CPB exceeding 180 minutes or an anticipated aortic cross-clamp time exceeding 120 minutes;
- Patients expected to have a postoperative endotracheal tube removal time exceeding 24 hours;
- Patients with prolonged fasting or inability to self-feed;
- A history of malignant tumor;
- Patients with unstable preoperative vital signs requiring intra-aortic balloon pump (IABP), extracorporeal membrane oxygenation (ECMO)assistance, or endotracheal tube-assisted ventilation;
- A history of cardiac surgery;
- Patients with preoperative gastrointestinal symptoms, such as nausea, vomiting and diarrhea;
- Patients with a history of dialysis before surgery;
- Patients with a history of atrial fibrillation before surgery;
- Patients on long-term hepatorenal protective medications;
- Patients with hepatic and renal insufficiency (Child-Pugh class B or C, estimated glomerular filtration rate <35 mL/min/1.73 m2);
- Patients with abnormal baseline inflammatory markers [interleukin-6 (IL6) >10 pg/mL, procalcitonin (PCT) >0.5 ng/mL, C reactive protein (CRP) >10 mg/L];
- Patients diagnosed with infectious diseases, inflammatory immune diseases, or tumor;
- Patients who have received immunosuppressive or anti-inflammatory treatment;
- Patients allergic or intolerant to colchicine;
- Breastfeeding or pregnant women;
- Other situations deemed inappropriate for participation in the study by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dongjin Wang, MD contact
China1 site, 1 recruiting
- Recruiting
Dong-Jin Wang
Nanjing, Jiangsu, 210008
Tuo Pan, MD, +8615205160210, pan_tuo@126.com
About this study
Official title: Effect of Colchicine on Perioperative Anti-inflammatory Organ Injury in Cardiac Surgery : a Multi-center, Randomized, Controlled, Double-blind Clinical Trial
All patients will be completed collection of demographic data, clinical data, and be observed for inflammatory organ damage, oxygenation index or SpO2/ FIO2, WBC, NEU, interleukin-1β, interleukin-6, interleukin-8 (IL-1β/6/8), tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), procalcitonin (PCT), myoglobin (Myo), creatine kinase-MB (CK-MB), high-sensitivity cardiac troponin T (hs-cTnT), neutrophil elastase (NE), myeloperoxidase (MPO), APACHE II score, alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin, Murray lung injury score, serum creatinine, eGFR, mechanical ventilation time, ICU length of stay, drug-related gastrointestinal reactions, and 30-day and 90-day all-cause mortality, among other indicators.
Read the detailed description
This study is a multicenter, randomized, controlled, double-blind, placebo- controlled clinical trial. A total of 768 patients who met the inclusion and exclusion criteria and were scheduled for cardiac surgery under cardiopulmonary bypass were enrolled. After signing informed consent, patients were randomly divided into the experimental group and the control group. Patients in the experimental group took 0.5mg of colchicine tablets orally for 3 days before surgery and continued to take 0.5mg daily for 10 days after tracheal extubation. Patients in the control group received an equivalent amount of starch placebo tablets, administered at the same times and in the same doses as the experimental group, during the colchicine/placebo treatment period, without affecting the patients' standard treatment protocols.
All patients will be completed collection of demographic data, clinical data, and be observed for inflammatory organ damage, oxygenation index or SpO2/ FIO2, WBC, NEU, interleukin-1β, interleukin-6, interleukin-8 (IL-1β/6/8), tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), procalcitonin (PCT), myoglobin (Myo), creatine kinase-MB (CK-MB), high-sensitivity cardiac troponin T (hs-cTnT), neutrophil elastase (NE), myeloperoxidase (MPO), APACHE II score, alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin, Murray lung injury score, serum creatinine, eGFR, mechanical ventilation time, ICU length of stay, drug-related gastrointestinal reactions, and 30-day and 90-day all-cause mortality, among other indicators. The study aims to investigate the impact of colchicine on the levels of inflammatory factors and prognosis in patients undergoing cardiac vascular surgery and to observe the potential organ damage to the heart, lungs, liver, kidneys, and the occurrence of adverse events such as leukopenia and thrombocytopenia. This is done to assess the safety of colchicine use in cardiac surgery patients.
- Conditions
- Inflammatory Response, Cardiac Disease
- Being tested
- Colchicine 0.5 MG, Placebo
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine 0.5 MGDrug
Also called Routine cardiovascular surgery and peri-operative management
Take 0.5mg of colchicine tablets orally for 3 days before surgery, and continued to take 0.5mg every other day (qod) for 10 days after tracheal extubation.
PlaceboDrug
Also called Routine cardiovascular surgery and peri-operative management
Take 0.5mg of starch tablets orally for 3 days before surgery, and continued to take 0.5mg every other day (qod) for 10 days after tracheal extubation.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group (colchicine group) | Experimental | The experimental group take 0.5mg of colchicine tablets orally for 3 days before surgery, and continue to take 0.5mg every other day (qod) for 10 days after tracheal extubation. Receives: Drug: Colchicine 0.5 MG |
| Control group | Placebo comparator | The control group take 0.5mg of placebo tablets orally for 3 days before surgery, and continue to take 0.5mg every other day (qod) for 10 days after tracheal extubation. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with POAF
POAF: Onset of new atrial fibrillation in patients within 10 days post-surgery.
Measured: postoperative 10 days
Number of Participants with PMI
PMI: Patient's high-sensitivity cardiac troponin T (hs-cTnT) exceeds 0.8 ng/L on the first day after surgery, and there is an increase of 10% or more on the second day compared to the first day postoperatively.
Measured: postoperative 10 days
Number of Participants with ARDS
ARDS: Acute Respiratory Distress Syndrome
Measured: postoperative 10 days
Number of Participants with PPS
PPS: post-pericardiotomy syndrome
Measured: postoperative 10 days
Secondary outcomes (16)
Oxygenation index
SpO2 /FIO2
Measured: postoperative day 1, 3, 5 and 7
Inflammatory index
WBC[×109/L], Neutrophil[NEU,%], Interleukin(IL)-1β[pg/mL], IL-6[pg/mL], IL-8[pg/mL], TNF-α[pg/mL], CRP[mg/L], PCT[ng/mL], neutrophil elastase[NE,ng/mL] and myeloperoxidase[MPO, ng/ml]
Measured: postoperative day 1, 3, 5 and 7
Myocardial injury marker
myoglobin[Myo, ng/ml], CK-MB[ng/ml], hs-cTnT[ng/ml]
Measured: postoperative day 1, 3, 5 and 7
Acute physiology and chronic health evaluation(APACHE II) socre
Interpretation of APACHE II : minimum 0 and maximum 71; increasing score is associated with an increasing risk of hospital death. acute physiology score, chronic health status score, and age adjustment score
Measured: postoperative day 1, 3, 5 and 7
Murray lung injury score
0 score - Indicates no lung injury; Less than 2.5 score - Indicates mild to moderate lung injury; More than 2.5 score - Indicates presence of severe ARDS. rs: respiratory rate, oxygenation, temperature, blood pressure, heart rate, and mental status
Measured: postoperative day 1, 3, 5 and 7
Liver and kidney function
ALT[U/L], AST[U/L], BUN[mmol/L], creatinine[μmol/L], eGFR[mL/min/1.73m2], total bilirubin[mg/dL]
Measured: postoperative day 1, 3, 5 and 7
DVMV
Duration of mechanical ventilation
Measured: postoperative 28 days
ICU time
Time to stay in the intensive care unit
Measured: postoperative 28 days
In-hospital time
All time during hospitalization
Measured: postoperative 28 days
30-day all-cause mortality
Proportion of deaths caused by various reasons within a certain period of time (30 days) compared to the total number of people in a certain group
Measured: postoperative 30 days
90-day all-cause mortality
Proportion of deaths caused by various reasons within a certain period of time (90 days) compared to the total number of people in a certain group
Measured: postoperative 90 days
Incidence of gastrointestinal reactions
Adverse reactions related to colchicine
Measured: postoperative 7 days
Surgical data
cardiopulmonary bypass time (min)
Measured: Surgical day
Surgical data
aortic cross-clamp time (min)
Measured: Surgical day
blood transfusion
blood transfusion volume(ml)
Measured: Surgical day
Rate of exudates on chest radiograph
Chest radiograph on postoperative days 1, 2, and 3, and chest CT within 14 days after surgery
Measured: postoperative 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start28 Jan 2024
- Primary completion31 Aug 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory ResponseStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 768 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University, Jinan Central Hospital, The First People's Hospital of Changzhou, Xinhua hospital of ILi in Kazakhstan automomous district, First Affiliated Hospital of Harbin Medical University, Yangzhou University, Shandong Provincial Hospital, Huai'an First People's Hospital, The First Affiliated Hospital of Shihezi University, Affiliated Hospital of Nantong University
- Responsible party
- Sponsor
- Investigators
- Tuo Pan, M.D, Study director, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolDongJin Wang, M.D, Study chair, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolDongJin Wang, M.D, Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118034
- Sponsor's protocol ID
- 2023-LCYJ-ZD-03
- Status last verified
- Oct 2025
- First submitted
- 24 Oct 2023
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li X, Luo Y, Cai X, Lv Z, Kong Y, Guo Q, Zhu J, Pan T, Wang D. Anti-inflammatory effect of colchicine on organ damage during the perioperative period of cardiac surgery: a study protocol for a multicentre, randomised, double-blind, placebo-controlled clinical trial. BMJ Open. 2024 Sep 12;14(9):e084368. doi: 10.1136/bmjopen-2024-084368.
PubMed 39266309
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Colchicine on Perioperative Anti-inflammatory Organ Injury in Cardiac Surgery : a Multi-center, Randomized, Controlled, Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT06118034
- Acronym / sponsor ID
- 2023-LCYJ-ZD-03
- Conditions
- Inflammatory Response, Cardiac Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 768 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University, Jinan Central Hospital, The First People's Hospital of Changzhou, Xinhua hospital of ILi in Kazakhstan automomous district, First Affiliated Hospital of Harbin Medical University, Yangzhou University, Shandong Provincial Hospital, Huai'an First People's Hospital, The First Affiliated Hospital of Shihezi University, Affiliated Hospital of Nantong University
- Study start
- 28 Jan 2024 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 7 Nov 2023 (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.
All patients will be completed collection of demographic data, clinical data, and be observed for inflammatory organ damage, oxygenation index or SpO2/ FIO2, WBC, NEU, interleukin-1β, interleukin-6, interleukin-8 (IL-1β/6/8), tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), procalcitonin (PCT), myoglobin (Myo), creatine kinase-MB (CK-MB), high-sensitivity cardiac troponin T (hs-cTnT), neutrophil elastase (NE), myeloperoxidase (MPO), APACHE II score, alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin, Murray lung injury score, serum creatinine, eGFR, mechanical ventilation time, ICU length of stay, drug-related gastrointestinal reactions, and 30-day and 90-day all-cause mortality, among other indicators.
Detailed description
This study is a multicenter, randomized, controlled, double-blind, placebo- controlled clinical trial. A total of 768 patients who met the inclusion and exclusion criteria and were scheduled for cardiac surgery under cardiopulmonary bypass were enrolled. After signing informed consent, patients were randomly divided into the experimental group and the control group. Patients in the experimental group took 0.5mg of colchicine tablets orally for 3 days before surgery and continued to take 0.5mg daily for 10 days after tracheal extubation. Patients in the control group received an equivalent amount of starch placebo tablets, administered at the same times and in the same doses as the experimental group, during the colchicine/placebo treatment period, without affecting the patients' standard treatment protocols.
All patients will be completed collection of demographic data, clinical data, and be observed for inflammatory organ damage, oxygenation index or SpO2/ FIO2, WBC, NEU, interleukin-1β, interleukin-6, interleukin-8 (IL-1β/6/8), tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), procalcitonin (PCT), myoglobin (Myo), creatine kinase-MB (CK-MB), high-sensitivity cardiac troponin T (hs-cTnT), neutrophil elastase (NE), myeloperoxidase (MPO), APACHE II score, alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin, Murray lung injury score, serum creatinine, eGFR, mechanical ventilation time, ICU length of stay, drug-related gastrointestinal reactions, and 30-day and 90-day all-cause mortality, among other indicators. The study aims to investigate the impact of colchicine on the levels of inflammatory factors and prognosis in patients undergoing cardiac vascular surgery and to observe the potential organ damage to the heart, lungs, liver, kidneys, and the occurrence of adverse events such as leukopenia and thrombocytopenia. This is done to assess the safety of colchicine use in cardiac surgery patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group (colchicine group) | Experimental | Drug: Colchicine 0.5 MGThe experimental group take 0.5mg of colchicine tablets orally for 3 days before surgery, and continue to take 0.5mg every other day (qod) for 10 days after tracheal extubation. |
| Control group | Placebo comparator | Drug: PlaceboThe control group take 0.5mg of placebo tablets orally for 3 days before surgery, and continue to take 0.5mg every other day (qod) for 10 days after tracheal extubation. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged between 50 and 80 years, male or female;
- Patients undergoing elective cardiac surgery;
- Have signed the informed consent form (ICF).
Key exclusion criteria (23 listed)
- Patients undergoing emergency surgery;
- Patients undergoing deep hypothermic circulatory arrest surgery;
- Preoperative predicted mortality >3% according to European System for Cardiac Operative Risk Evaluation II (EuroSCORE II);
- Patients undergoing off-pump coronary artery bypass grafting (off-pump CABG) surgery;
- Patients undergoing left or right ventricular outflow tract obstruction surgery;
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 |
|---|---|---|
| Colchicine 0.5 MGAlso: Routine cardiovascular surgery and peri-operative managementTake 0.5mg of colchicine tablets orally for 3 days before surgery, and continued to take 0.5mg every other day (qod) for 10 days after tracheal extubation. | Drug | Experimental group (colchicine group) |
| PlaceboAlso: Routine cardiovascular surgery and peri-operative managementTake 0.5mg of starch tablets orally for 3 days before surgery, and continued to take 0.5mg every other day (qod) for 10 days after tracheal extubation. | Drug | Control group |
Primary outcome
Number of Participants with POAF
Time frame: postoperative 10 days
POAF: Onset of new atrial fibrillation in patients within 10 days post-surgery.
Number of Participants with PMI
Time frame: postoperative 10 days
PMI: Patient's high-sensitivity cardiac troponin T (hs-cTnT) exceeds 0.8 ng/L on the first day after surgery, and there is an increase of 10% or more on the second day compared to the first day postoperatively.
Number of Participants with ARDS
Time frame: postoperative 10 days
ARDS: Acute Respiratory Distress Syndrome
Number of Participants with PPS
Time frame: postoperative 10 days
PPS: post-pericardiotomy syndrome
16 secondary outcomes
Oxygenation index
Time frame: postoperative day 1, 3, 5 and 7
Inflammatory index
Time frame: postoperative day 1, 3, 5 and 7
Myocardial injury marker
Time frame: postoperative day 1, 3, 5 and 7
Acute physiology and chronic health evaluation(APACHE II) socre
Time frame: postoperative day 1, 3, 5 and 7
Murray lung injury score
Time frame: postoperative day 1, 3, 5 and 7
Liver and kidney function
Time frame: postoperative day 1, 3, 5 and 7
DVMV
Time frame: postoperative 28 days
ICU time
Time frame: postoperative 28 days
In-hospital time
Time frame: postoperative 28 days
30-day all-cause mortality
Time frame: postoperative 30 days
90-day all-cause mortality
Time frame: postoperative 90 days
Incidence of gastrointestinal reactions
Time frame: postoperative 7 days
Surgical data
Time frame: Surgical day
Surgical data
Time frame: Surgical day
blood transfusion
Time frame: Surgical day
Rate of exudates on chest radiograph
Time frame: postoperative 14 days
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 17 Nov 2025.
- Derived from this study: PubMed 39266309Li X, Luo Y, Cai X, Lv Z, Kong Y, Guo Q, Zhu J, Pan T, Wang D. Anti-inflammatory effect of colchicine on organ damage during the perioperative period of cardiac surgery: a study protocol for a multicentre, randomised, double-blind, placebo-controlled clinical trial. BMJ Open. 2024 Sep 12;14(9):e084368. doi: 10.1136/bmjopen-2024-084368.
- 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.
Dongjin Wang, MD contact
Tuo Pan, M.D study director
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
DongJin Wang, M.D study chair
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
DongJin Wang, M.D principal investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Colchicine 0.5 MG in people with Inflammatory Response and Cardiac Disease, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
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 23 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 17 Nov 2025. 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 China. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Tuo Pan, MD (+8615205160210, pan_tuo@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with POAF (time frame: postoperative 10 days). The study lists 4 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 NCT06118034, which also lists 1 linked publication.
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 17 Nov 2025.