Post-Operative Atrial Fibrillation After Coronary Artery Bypass Grafting (CABG)Phase 2/3NCT07611019
Colchicine for the Prevention of Post-Operative Atrial Fibrillation After Coronary Artery Bypass Grafting: A Single-Center, Strategy-Stratified, Randomized, Double-Blind, Placebo-Controlled Trial
A Phase 2/3 study testing Colchicine 0.5 MG oral tablet twice daily in people with Post-Operative Atrial Fibrillation After Coronary Artery Bypass Grafting (CABG), run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Post-operative atrial fibrillation after coronary artery bypass grafting (CABG) Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Post-Operative Atrial Fibrillation After Coronary Artery Bypass Grafting (CABG)
- What is being tested?
- Colchicine 0.5 MG oral tablet twice daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Jul 2026to Jul 2028
- Phase
- Phase 2/3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 20 years or older scheduled to undergo elective coronary artery bypass grafting (CABG), including either off-pump CABG or on-pump CABG.
- Ability to receive oral study medication before and after surgery.
- Provision of written informed consent before randomization.
Who cannot join
- History of atrial fibrillation or atrial flutter before surgery.
- Severe renal impairment (estimated glomerular filtration rate <30 mL/min/1.73 m²) or chronic dialysis.
- Severe hepatic dysfunction.
- Known hypersensitivity or previous severe adverse reaction to colchicine.
- Pregnancy or breastfeeding.
- Current use of strong CYP3A4 or P-glycoprotein inhibitors that cannot be safely discontinued or substituted.
- Any condition judged by the investigators to interfere with study participation or safety assessment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled Trial of Colchicine to Prevent Post-Operative Atrial Fibrillation After CABG With Strategy-Stratified Randomization
Post-operative atrial fibrillation after coronary artery bypass grafting (CABG)
Read the detailed description
This single-center, prospective, randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy of colchicine in preventing post-operative atrial fibrillation (POAF) following coronary artery bypass grafting (CABG) and to compare its pharmacologic and clinical effects between different surgical strategies - off-pump CABG (OPCAB) and on-pump CABG (ONCAB).
Post-operative atrial fibrillation is one of the most common arrhythmias after CABG, with an incidence of approximately 50%, and is associated with prolonged ICU and hospital stay and increased healthcare utilization. Intravenous amiodarone is commonly used for POAF treatment but may increase the risk of catheter-related infection. Colchicine, an anti-inflammatory and immunomodulatory agent, has shown potential to reduce postpericardiotomy syndrome and POAF in small-scale studies, but existing evidence remains inconsistent, and most prior trials did not distinguish between surgical strategies.
In this trial, 400 adult patients undergoing elective CABG will be enrolled and randomized in a 1:1 ratio within each stratum (OPCAB and ONCAB) to receive either colchicine or placebo. The treatment group will receive colchicine 0.5 mg orally twice daily, starting on postoperative day -3 and continuing through postoperative day 7. The placebo group will receive identically appearing tablets on the same schedule.
The primary endpoint is the incidence of new-onset atrial fibrillation within 14 days after surgery, defined as any episode lasting ≥30 seconds documented by 12-lead ECG, continuous telemetry, or Holter monitoring.
Secondary outcomes include the incidence and management of other arrhythmias (atrial flutter, supraventricular tachycardia), total dose and duration of intravenous amiodarone, ICU and total hospital length of stay, ischemic stroke or TIA, infection events (including catheter-related infection), and 30-day readmission. Safety outcomes will include gastrointestinal intolerance, hepatic enzyme elevation, creatine kinase elevation with myalgia, hematologic abnormalities, and serious adverse events (SAE).
Pharmacokinetic (PK) and pharmacodynamic (PD) analyses will measure colchicine concentrations in plasma and pericardial fluid and correlate these with inflammatory biomarkers (CRP, IL-6, TNF-α, white blood cell profile, and immune cell phenotyping by flow cytometry). This integrated approach aims to elucidate the relationship between colchicine exposure, inflammation, and POAF occurrence.
Statistical analyses will primarily follow an intention-to-treat (ITT) approach. The primary endpoint will be evaluated using a log-binomial or Poisson-robust model to estimate relative risk (RR) with 95% confidence intervals, including treatment, surgical strategy, and their interaction terms. Time-to-event outcomes will be analyzed using Cox proportional hazards or Kaplan-Meier methods, and continuous variables by linear mixed-effects models. Missing data will be handled conservatively with multiple imputation where appropriate. An independent Data and Safety Monitoring Board (DSMB) will review blinded safety data once 50% of subjects have been enrolled.
The trial is expected to clarify the pharmacokinetic and clinical effects of colchicine in different CABG surgical strategies. If colchicine is shown to effectively reduce POAF in OPCAB patients or in those achieving sufficient plasma concentrations, it may provide a simple, low-cost preventive strategy that reduces the need for intravenous amiodarone, lowers infection risk, and shortens ICU and hospital stay. The results could guide future optimization of dosing and timing strategies in ONCAB patients and improve perioperative management and resource utilization in cardiac surgery.
- Being tested
- Colchicine 0.5 MG oral tablet twice daily, Placebo Oral Tablet
- Keywords
- colchicine, postoperative atrial fibrillation, coronary artery bypass grafting, off-pump surgery, cardiopulmonary bypass, pharmacokinetics, inflammation, neutrophil extracellular traps
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine 0.5 MG oral tablet twice dailyDrug
Colchicine 0.5 mg administered orally twice daily beginning 3 days before surgery and continuing through postoperative day 7. Temporary interruption or discontinuation is permitted for clinically significant adverse events according to the study safety protocol.
Placebo Oral TabletDrug
Matching placebo tablet administered orally twice daily beginning 3 days before surgery and continuing through postoperative day 7 under double-blind conditions.
| Study group | Role | What they receive |
|---|---|---|
| Colchicine Group | Experimental | Participants will receive colchicine 0.5 mg orally twice daily starting 3 days before surgery and continuing through postoperative day 7 under double-blind conditions. Randomization is stratified by surgical strategy (off-pump CABG versus on-pump CABG). Receives: Drug: Colchicine 0.5 MG oral tablet twice daily |
| Placebo Group | Placebo comparator | Participants will receive an identically appearing placebo tablet orally twice daily starting 3 days before surgery and continuing through postoperative day 7 under double-blind conditions. Randomization is stratified by surgical strategy (off-pump CABG versus on-pump CABG). Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of new-onset atrial fibrillation within 14 days after CABG surgery
New-onset atrial fibrillation (AF) or atrial flutter (AFL) lasting ≥30 seconds, documented by 12-lead ECG, continuous telemetry monitoring, or 24-hour Holter recording, occurring within 14 days after coronary artery bypass grafting (CABG).
Events are adjudicated by blinded cardiologists according to prespecified criteria.
Measured: From the day of surgery through postoperative day 14.
Secondary outcomes (7)
Total duration of post-operative atrial fibrillation (POAF)
Cumulative duration (in hours) of all atrial fibrillation or atrial flutter episodes documented by telemetry or ECG monitoring within 14 days after surgery.
Measured: From the day of surgery through postoperative day 14.
Proportion of patients requiring cardioversion for POAF
Percentage of patients who undergo pharmacologic or electrical cardioversion for atrial fibrillation/flutter occurring within 14 days after surgery.
Measured: From the day of surgery through postoperative day 14.
Total dose of intravenous amiodarone used for POAF treatment
Total cumulative intravenous amiodarone dose (mg) administered for POAF management during the first 14 postoperative days.
Measured: From the day of surgery through postoperative day 14.
Length of stay in the intensive care unit (ICU)
Duration (days) of ICU hospitalization from the date of surgery until discharge from the intensive care unit.
Measured: From the date of surgery until discharge from the intensive care unit or death, whichever occurred first, assessed up to 30 days after surgery.
Total hospital length of stay
Total number of days from hospital admission for CABG surgery until hospital discharge.
Measured: From hospital admission until hospital discharge or death, whichever occurred first, assessed up to 60 days after surgery.
30-day hospital readmission
Incidence of unplanned hospital readmission for any cause within 30 days after discharge from index CABG hospitalization.
Measured: From hospital discharge until 30 days after discharge.
Plasma and pericardial fluid colchicine concentrations
Measured colchicine concentrations (ng/mL) in plasma and pericardial fluid at predefined perioperative time points(preoperative baseline, end of surgery, postoperative day 1, postoperative day 3, and postoperative day 7)for pharmacokinetic analysis.
Measured: From preoperative day 1 through postoperative day 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start6 Jul 2026
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post-Operative Atrial Fibrillation After Coronary Artery Bypass Grafting (CABG)Studies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Clinical Trial Center, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07611019
- Sponsor's protocol ID
- 202509059MIND
- Status last verified
- Jul 2026
- First submitted
- 24 Feb 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) collected in this study will not be shared because they include sensitive clinical and biological information linked to hospital medical records. Data sharing is restricted by institutional and national privacy regulations. Only de-identified, aggregate summary data will be available in publications or presentations after study completion.
Publications
Imazio M, Brucato A, Ferrazzi P, Rovere ME, Gandino A, Cemin R, Ferrua S, Belli R, Maestroni S, Simon C, Zingarelli E, Barosi A, Sansone F, Patrini D, Vitali E, Trinchero R, Spodick DH, Adler Y; COPPS Investigators. Colchicine reduces postoperative atrial fibrillation: results of the Colchicine for the Prevention of the Postpericardiotomy Syndrome (COPPS) atrial fibrillation substudy. Circulation. 2011 Nov 22;124(21):2290-5. doi: 10.1161/CIRCULATIONAHA.111.026153. Epub 2011 Nov 16.
PubMed 22090167Zhao H, Chen Y, Mao M, Yang J, Chang J. A meta-analysis of colchicine in prevention of atrial fibrillation following cardiothoracic surgery or cardiac intervention. J Cardiothorac Surg. 2022 Sep 1;17(1):224. doi: 10.1186/s13019-022-01958-9.
PubMed 36050741Wang MX, Deng XL, Mu BY, Cheng YJ, Chen YJ, Wang Q, Huang J, Zhou RW, Huang CB. Effect of colchicine in prevention of pericardial effusion and atrial fibrillation: a meta-analysis. Intern Emerg Med. 2016 Sep;11(6):867-76. doi: 10.1007/s11739-016-1496-5. Epub 2016 Jul 4.
PubMed 27378573
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled Trial of Colchicine to Prevent Post-Operative Atrial Fibrillation After CABG With Strategy-Stratified Randomization
- ClinicalTrials.gov ID
- NCT07611019
- Acronym / sponsor ID
- 202509059MIND
- Keywords
- colchicine, postoperative atrial fibrillation, coronary artery bypass grafting, off-pump surgery, cardiopulmonary bypass, pharmacokinetics, inflammation, neutrophil extracellular traps
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 6 Jul 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 28 May 2026 (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.
Post-operative atrial fibrillation after coronary artery bypass grafting (CABG)
Detailed description
This single-center, prospective, randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy of colchicine in preventing post-operative atrial fibrillation (POAF) following coronary artery bypass grafting (CABG) and to compare its pharmacologic and clinical effects between different surgical strategies - off-pump CABG (OPCAB) and on-pump CABG (ONCAB).
Post-operative atrial fibrillation is one of the most common arrhythmias after CABG, with an incidence of approximately 50%, and is associated with prolonged ICU and hospital stay and increased healthcare utilization. Intravenous amiodarone is commonly used for POAF treatment but may increase the risk of catheter-related infection. Colchicine, an anti-inflammatory and immunomodulatory agent, has shown potential to reduce postpericardiotomy syndrome and POAF in small-scale studies, but existing evidence remains inconsistent, and most prior trials did not distinguish between surgical strategies.
In this trial, 400 adult patients undergoing elective CABG will be enrolled and randomized in a 1:1 ratio within each stratum (OPCAB and ONCAB) to receive either colchicine or placebo. The treatment group will receive colchicine 0.5 mg orally twice daily, starting on postoperative day -3 and continuing through postoperative day 7. The placebo group will receive identically appearing tablets on the same schedule.
The primary endpoint is the incidence of new-onset atrial fibrillation within 14 days after surgery, defined as any episode lasting ≥30 seconds documented by 12-lead ECG, continuous telemetry, or Holter monitoring.
Secondary outcomes include the incidence and management of other arrhythmias (atrial flutter, supraventricular tachycardia), total dose and duration of intravenous amiodarone, ICU and total hospital length of stay, ischemic stroke or TIA, infection events (including catheter-related infection), and 30-day readmission. Safety outcomes will include gastrointestinal intolerance, hepatic enzyme elevation, creatine kinase elevation with myalgia, hematologic abnormalities, and serious adverse events (SAE).
Pharmacokinetic (PK) and pharmacodynamic (PD) analyses will measure colchicine concentrations in plasma and pericardial fluid and correlate these with inflammatory biomarkers (CRP, IL-6, TNF-α, white blood cell profile, and immune cell phenotyping by flow cytometry). This integrated approach aims to elucidate the relationship between colchicine exposure, inflammation, and POAF occurrence.
Statistical analyses will primarily follow an intention-to-treat (ITT) approach. The primary endpoint will be evaluated using a log-binomial or Poisson-robust model to estimate relative risk (RR) with 95% confidence intervals, including treatment, surgical strategy, and their interaction terms. Time-to-event outcomes will be analyzed using Cox proportional hazards or Kaplan-Meier methods, and continuous variables by linear mixed-effects models. Missing data will be handled conservatively with multiple imputation where appropriate. An independent Data and Safety Monitoring Board (DSMB) will review blinded safety data once 50% of subjects have been enrolled.
The trial is expected to clarify the pharmacokinetic and clinical effects of colchicine in different CABG surgical strategies. If colchicine is shown to effectively reduce POAF in OPCAB patients or in those achieving sufficient plasma concentrations, it may provide a simple, low-cost preventive strategy that reduces the need for intravenous amiodarone, lowers infection risk, and shortens ICU and hospital stay. The results could guide future optimization of dosing and timing strategies in ONCAB patients and improve perioperative management and resource utilization in cardiac surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colchicine Group | Experimental | Drug: Colchicine 0.5 MG oral tablet twice dailyParticipants will receive colchicine 0.5 mg orally twice daily starting 3 days before surgery and continuing through postoperative day 7 under double-blind conditions. Randomization is stratified by surgical strategy (off-pump CABG versus on-pump CABG). |
| Placebo Group | Placebo comparator | Drug: Placebo Oral TabletParticipants will receive an identically appearing placebo tablet orally twice daily starting 3 days before surgery and continuing through postoperative day 7 under double-blind conditions. Randomization is stratified by surgical strategy (off-pump CABG versus on-pump CABG). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 20 years or older scheduled to undergo elective coronary artery bypass grafting (CABG), including either off-pump CABG or on-pump CABG.
- Ability to receive oral study medication before and after surgery.
- Provision of written informed consent before randomization.
Key exclusion criteria (7 listed)
- History of atrial fibrillation or atrial flutter before surgery.
- Severe renal impairment (estimated glomerular filtration rate <30 mL/min/1.73 m²) or chronic dialysis.
- Severe hepatic dysfunction.
- Known hypersensitivity or previous severe adverse reaction to colchicine.
- Pregnancy or breastfeeding.
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 MG oral tablet twice dailyColchicine 0.5 mg administered orally twice daily beginning 3 days before surgery and continuing through postoperative day 7. Temporary interruption or discontinuation is permitted for clinically significant adverse events according to the study safety protocol. | Drug | Colchicine Group |
| Placebo Oral TabletMatching placebo tablet administered orally twice daily beginning 3 days before surgery and continuing through postoperative day 7 under double-blind conditions. | Drug | Placebo Group |
Primary outcome
Incidence of new-onset atrial fibrillation within 14 days after CABG surgery
Time frame: From the day of surgery through postoperative day 14.
New-onset atrial fibrillation (AF) or atrial flutter (AFL) lasting ≥30 seconds, documented by 12-lead ECG, continuous telemetry monitoring, or 24-hour Holter recording, occurring within 14 days after coronary artery bypass grafting (CABG). Events are adjudicated by blinded cardiologists according to prespecified criteria.
7 secondary outcomes
Total duration of post-operative atrial fibrillation (POAF)
Time frame: From the day of surgery through postoperative day 14.
Proportion of patients requiring cardioversion for POAF
Time frame: From the day of surgery through postoperative day 14.
Total dose of intravenous amiodarone used for POAF treatment
Time frame: From the day of surgery through postoperative day 14.
Length of stay in the intensive care unit (ICU)
Time frame: From the date of surgery until discharge from the intensive care unit or death, whichever occurred first, assessed up to 30 days after surgery.
Total hospital length of stay
Time frame: From hospital admission until hospital discharge or death, whichever occurred first, assessed up to 60 days after surgery.
30-day hospital readmission
Time frame: From hospital discharge until 30 days after discharge.
Plasma and pericardial fluid colchicine concentrations
Time frame: From preoperative day 1 through postoperative day 7.
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 Jul 2026.
- Results publication: PubMed 22090167Imazio M, Brucato A, Ferrazzi P, Rovere ME, Gandino A, Cemin R, Ferrua S, Belli R, Maestroni S, Simon C, Zingarelli E, Barosi A, Sansone F, Patrini D, Vitali E, Trinchero R, Spodick DH, Adler Y; COPPS Investigators. Colchicine reduces postoperative atrial fibrillation: results of the Colchicine for the Prevention of the Postpericardiotomy Syndrome (COPPS) atrial fibrillation substudy. Circulation. 2011 Nov 22;124(21):2290-5. doi: 10.1161/CIRCULATIONAHA.111.026153. Epub 2011 Nov 16.
- Results publication: PubMed 36050741Zhao H, Chen Y, Mao M, Yang J, Chang J. A meta-analysis of colchicine in prevention of atrial fibrillation following cardiothoracic surgery or cardiac intervention. J Cardiothorac Surg. 2022 Sep 1;17(1):224. doi: 10.1186/s13019-022-01958-9.
- Results publication: PubMed 27378573Wang MX, Deng XL, Mu BY, Cheng YJ, Chen YJ, Wang Q, Huang J, Zhou RW, Huang CB. Effect of colchicine in prevention of pericardial effusion and atrial fibrillation: a meta-analysis. Intern Emerg Med. 2016 Sep;11(6):867-76. doi: 10.1007/s11739-016-1496-5. Epub 2016 Jul 4.
- Individual participant dataSharing planned: No. The individual participant data (IPD) collected in this study will not be shared because they include sensitive clinical and biological information linked to hospital medical records. Data sharing is restricted by institutional and national privacy regulations. Only de-identified, aggregate summary data will be available in publications or presentations after study completion.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Colchicine 0.5 MG oral tablet twice daily in people with Post-Operative Atrial Fibrillation After Coronary Artery Bypass Grafting (CABG), run by National Taiwan University Hospital at 1 site in Taiwan.
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 7 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: enrolling by invitation, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
Incidence of new-onset atrial fibrillation within 14 days after CABG surgery (time frame: From the day of surgery through postoperative day 14.). 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 NCT07611019, which also lists 3 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 10 Jul 2026.