Coronary Artery Bypass SurgeryPhase 2NCT03252093
Evaluation of the Safety and Efficacy of Ang-(1-7) to Enhance Cognitive Function in Participants Undergoing CABG
A Phase 2 study testing Angiotensin-(1-7) in people with Coronary Artery Bypass Surgery and Cognitive Impairment, run by University of Arizona at 5 sites in United States.
Trial summary
Coronary Artery Bypass Graft (CABG) is a surgical procedure known to be associated with cognitive impairment. Mechanisms of cognitive impairment are complex but may include insufficient oxygenation and inflammation due to exposure to the bypass circuit. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Coronary Artery Bypass Surgery, Cognitive Impairment
- What is being tested?
- Angiotensin-(1-7)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 5 sitesUnited States
- Study dates
- 20 Jul 2017to 15 Nov 2022
- Phase
- Phase 2
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male or female first time cardiac surgical participants
- Elective on pump coronary artery bypass grafting (CABG)
- Age 60-80
- Signed, informed consent
- Geriatric Depression Scale score less than or = 14or Beck's Depression Inventory less than or = 20
- Score > or = 25 on the Mini-Mental State Examination (MMSE)
Who cannot join
- Recent (within 60 days) Cerebrovascular disease with neurological change
- Malignancy or pre-malignant state within 5 years not including non-melanoma skin cancer
- History of liver dysfunction with ongoing sequelae (including but not limited to liver enzymes > 2.5 x upper limit or normal (ULN) at screening).
- History of renal dysfunction with ongoing sequelae (including but not limited to creatinine value > 2.5 mg/dL at screening).
- Significant Lung Disease (FEV1< 1.5 L, pO2 <70 on room air, pCO2 >45)
- Presence of any severe mental illness that could affect interpretation of efficacy data, such as schizophrenia or bipolar affective disorder; any untreated or unstable psychiatric condition including depressive disorder or anxiety disorder.
Show all 20Show fewer
- Active substance abuse
- Less than Grade 7 education or inability to read and perform cognitive assessment.
- Significant neurological disorder affecting memory
- Uncontrolled atrial fibrillation prior to surgery
- Concurrent use of prescription medications specifically for memory enhancement including herbal or natural supplements
- General anesthesia (defined as anesthesia requiring intubation or ventilatory support) within 3 months prior to randomization.
- Cardiopulmonary bypass or thoracotomy within 2 years prior to randomization.
- Chronic obstructive pulmonary disease (COPD) requiring oxygen therapy.
- Participants on immunosuppressive drugs, such as azathioprine, chemotherapeutic agents, mycophenolate, monoclonal antibodies, or more than 20 mg/day prednisone, within the previous 3 months
- Receipt of any investigational agent or device within 30 days of screening
- MRI contraindication not limited to abnormally high weight or height to fit in scanner (Bore 70cm); Presence of device/hardware incompatible with MR imaging
- Conditions causing severe anemia
- Participant is practicing Jehovah Witness
- Sexually active males not practicing a medically acceptable method of contraception, unless there is documented azoospermia.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Suburban Hospital
Bethesda, Maryland, 20814
National Institutes of Health
Bethesda, Maryland, 20892
INOVA Heart & Vascular Research
Falls Church, Virginia, 22042
Banner- University Medical Center Phoenix
Phoenix, Arizona, 85006
University of Arizona Sarver Heart Center
Tucson, Arizona, 85724
About this study
Official title: A Randomized, Placebo-controlled, Double Blind Evaluation of the Safety and Efficacy of Angiotensin 1-7 (Ang-(1-7)) to Enhance Cognitive Function in Participants Undergoing Coronary Artery Bypass Graft (CABG) Surgery.
Coronary Artery Bypass Graft (CABG) is a surgical procedure known to be associated with cognitive impairment. Mechanisms of cognitive impairment are complex but may include insufficient oxygenation and inflammation due to exposure to the bypass circuit. Currently there are no approved therapeutics for the prevention or treatment of cognitive impairment in these patients.
A small peptide, Angiotensin-(1-7) [Ang-(1-7)], is known to decrease inflammation in the brain in animal models. Early studies in humans have shown it to be safe. This peptide is naturally produced by the body and has anti-inflammatory and vasodilatory effects. Investigators believe that Ang-(1-7) may be able to help lower the risk of cognitive dysfunction in patients undergoing CABG.
The goal of this project is to explore effects of the experimental peptide Angiotensin-(1-7) (Ang-(1-7) in patients undergoing an elective CABG surgery to determine its safety and efficacy to prevent cognitive dysfunction in patients undergoing CABG.
Read the detailed description
Up to 104 participants (ages 60-80) undergoing elective CABG surgery at the Banner University Medical Center in Tucson, AZ or at Suburban Hospital/NIH Clinical Center in Bethesda, MD, will be enrolled in this randomized, placebo-controlled, double-blind study of Angiotensin-(1-7). Subjects who have a pre-operative neurologic, learning or psychiatric disorder will be excluded. In addition, a concurrent group of 20 age-matched adults will be recruited as a neuropsychological control group and will undergo neuropsychological testing at baseline, Day 21 and Day 90.
Participants will be asked to undergo a screening process to confirm eligibility and to rule out depression, dementia and contraindications to MRI. Prior to randomization, baseline measures will include neuropsychological testing, brain MRI, quality of life questionnaires, inflammatory markers and DNA/RNA sample collection. Participants will be treated for 21 days with a daily dose of subcutaneous Ang-(1-7) (100 mcg/kg/day) (n=60) or placebo (n=30). These measures will then be repeated at Day 21 and Day 90. The MRI will be repeated at Day 21 only.
Pharmacokinetic measurements will be obtained prior to administration of Ang-(1-7) or placebo and hourly for 6 hours following the first 6 doses. Delirium testing will occur on a daily basis post surgery until discharge. Serum study drug level will be obtained at Day 21.
Lastly, subjects will be followed on a weekly basis by telephone for all 12 weeks of the study.
- Primary Objective: To evaluate the safety and tolerability of 21 days of subcutaneous (s.c.) once daily administration of Ang-(1-7) in eligible participants undergoing first-time, elective coronary artery bypass graft (CABG) surgery.
- Secondary Objectives:
- To determine the pharmacokinetics of 21 days of treatment with Ang-(1-7).
- To determine if 21 days of treatment with 200 mcg/kg/day of Ang-(1-7) improves memory function measured as a change in performance from baseline to follow up on a composite score comprised of memory, executive functioning, language and processing speed in Ang-(1-7) treatment group compared to placebo controls and non-surgical controls.
- To determine if treatment with 200 mcg/kg/day Ang-(1-7) decreases postoperative delirium length and severity as measured with the Confusion Assessment Method (CAM) D2 to D7 ( or discharge) after surgery as compared to treatment with placebo group.
- To determine if 21 days of treatment with 200 mcg/kg/day Ang-(1-7) improves participant self-reported outcomes using standardized Kansas City Cardiomyopathy Questionnaire (KCCQ) and Instrumental Activities of Daily Living (IADL) measurement tools.
- To determine if 21 days treatment with 200 mcg/kg/day Ang-(1-7) results in changes in suicidal ideation and behavior as assessed by The Columbia Suicide Severity Rating Scale (C-SSRS).
- To compare postoperative mortality and morbidity at 90 days in the 200 mcg/kg/day Ang-(1-7) treatment group with the placebo group.
- To determine if 21 days of treatment of 200 mcg/kg/day Ang-(1-7) decreases postoperative observable changes in brain fractional anisotropy as measured by diffuse on magnetic resonance imaging (MRI) as compared to placebo.
- Being tested
- Angiotensin-(1-7), Placebo for Angiotensin-(1-7)
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiotensin-(1-7)Drug
Subcutaneous injection of 200 mcg/kg/day
Placebo for Angiotensin-(1-7)Drug
Subcutaneous injection of Placebo
| Study group | Role | What they receive |
|---|---|---|
| Angiotensin-(1-7) | Experimental | Intervention: Drug: 200 mcg/kg/day injected subcutaneously once daily for 21 days Receives: Drug: Angiotensin-(1-7) |
| Placebo for Angiotensin-(1-7) | Placebo comparator | Intervention: Placebo for Angiotensin-(1-7) injected subcutaneously once daily for 21 days Receives: Drug: Placebo for Angiotensin-(1-7) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate 21 days daily administration of Ang-(1-7) in participants undergoing 1st time CABG surgery is safe and efficacious as assessed by the number of related AEs grade 3 or > and change in composite neuropsychological score up to Day 90.
Adverse events (AEs), including serious adverse events (SAEs) will be monitored from the time of enrollment through Day 90. The number of AEs, withdrawals due to AE, and withdrawals for other reasons will be tabulated. Additional assessments include: serum blood levels of the Ang-(1-7) at Day 1, Day 3, Day 5 or Discharge and Day 21. Lastly blood pressuring monitoring pre and post treatment will occur Day 1 to discharge.
Change in performance on composite scores of memory, executive functioning, language and processing speed in the treatment arm compared to placebo arm and non-surgical controls measured at 3 time points will assess the effectiveness of Ang-(1-7) in reducing postoperative cognitive impairment in CABG patients.
Measured: Up to Day 90
Secondary outcomes (4)
Demonstrated change in the neuropsychological component scores assessed at baseline, Day 21 and Day 90 in the treatment and placebo arms.
The component scores to be analyzed will include Rey Auditory Verbal Learning Test (RAVLT) and Confusion Assessment Method (CAM), assessment of general intellectual functioning (North American Adult Reading Test), prospective memory (MIST; Memory Intentions Test) , Visual Paired Associates, Object-Spatial Locations, three areas of executive functions including updating (Keep Track), shifting (Letter-Number), and inhibition (Stroop Color-Word), and psychomotor speed (Deary Simple and Complex Reaction Times, Trials A and B).
Measured: Up to Day 90
Evidence of change in fractional anisotropy from diffusion tensor imaging on Brain MRI at baseline versus post operative Day 21 will be assessed in the treatment and placebo arms as a measure of efficacy.
CABG surgery will result in observable changes in gray matter volumes and integrity of white matter as measured by structural and diffusion MR imaging in all participants. Similar voxel-based multivariate regression analyses will be used for other MRI measures including gray and white matter volumes, axial and radial diffusion, and ASL perfusion. Comparisons between CABG patients and controls will use the general linear model in SPM8 with group (CABG, controls) as a categorical factor and age as a mean-centered control variable. For structural MRI, ICV will also be included as a covariate.
Measured: Up to Day 21
Demonstrated change in PBR28 VT/fP, a quantitative measure of TSPO receptor density, in a composite cerebral region-of-interest (ROI) derived from brain PET imaging in the treatment and placebo arms.
PBR28 VT/fP will be measured in a composite cerebral region-of-interest (ROI), including automatic anatomically labeled, bilateral medial and lateral temporal, parietal, precuneus, prefrontal ROIs (Reiman, 2009) in the treatment and placebo arms.
Measured: Up to Day 21
Demonstrated associations between neuropsychogical test results, MRI findings and PBR28 binding in all participants.
Neuropsychological testing outcomes and MRI findings will analyzed to evaluate associations between these outcomes and PBR28 binding. In addition, systemic inflammatory markers will be measured, including GM-CSF, IFNγ, IL-1 β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12 (p70), IL-13, and TNFα.
Measured: Up to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start20 Jul 2017
- Primary completion15 Nov 2022
- Study completion15 Nov 2022
Why it stopped: Funding ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass SurgeryStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Suburban Hospital
- Responsible party
- Sponsor
- Investigators
- Nancy K Sweitzer, MD, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252093
- Sponsor's protocol ID
- HL131014
- Other IDs
- 1U01HL131014-01A1
- Status last verified
- May 2025
- First submitted
- 1 Aug 2017
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double Blind Evaluation of the Safety and Efficacy of Angiotensin 1-7 (Ang-(1-7)) to Enhance Cognitive Function in Participants Undergoing Coronary Artery Bypass Graft (CABG) Surgery.
- ClinicalTrials.gov ID
- NCT03252093
- Acronym / sponsor ID
- HL131014
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding ended
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Suburban Hospital
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 17 Aug 2017 (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.
Coronary Artery Bypass Graft (CABG) is a surgical procedure known to be associated with cognitive impairment. Mechanisms of cognitive impairment are complex but may include insufficient oxygenation and inflammation due to exposure to the bypass circuit. Currently there are no approved therapeutics for the prevention or treatment of cognitive impairment in these patients.
A small peptide, Angiotensin-(1-7) [Ang-(1-7)], is known to decrease inflammation in the brain in animal models. Early studies in humans have shown it to be safe. This peptide is naturally produced by the body and has anti-inflammatory and vasodilatory effects. Investigators believe that Ang-(1-7) may be able to help lower the risk of cognitive dysfunction in patients undergoing CABG.
The goal of this project is to explore effects of the experimental peptide Angiotensin-(1-7) (Ang-(1-7) in patients undergoing an elective CABG surgery to determine its safety and efficacy to prevent cognitive dysfunction in patients undergoing CABG.
Detailed description
Up to 104 participants (ages 60-80) undergoing elective CABG surgery at the Banner University Medical Center in Tucson, AZ or at Suburban Hospital/NIH Clinical Center in Bethesda, MD, will be enrolled in this randomized, placebo-controlled, double-blind study of Angiotensin-(1-7). Subjects who have a pre-operative neurologic, learning or psychiatric disorder will be excluded. In addition, a concurrent group of 20 age-matched adults will be recruited as a neuropsychological control group and will undergo neuropsychological testing at baseline, Day 21 and Day 90.
Participants will be asked to undergo a screening process to confirm eligibility and to rule out depression, dementia and contraindications to MRI. Prior to randomization, baseline measures will include neuropsychological testing, brain MRI, quality of life questionnaires, inflammatory markers and DNA/RNA sample collection. Participants will be treated for 21 days with a daily dose of subcutaneous Ang-(1-7) (100 mcg/kg/day) (n=60) or placebo (n=30). These measures will then be repeated at Day 21 and Day 90. The MRI will be repeated at Day 21 only.
Pharmacokinetic measurements will be obtained prior to administration of Ang-(1-7) or placebo and hourly for 6 hours following the first 6 doses. Delirium testing will occur on a daily basis post surgery until discharge. Serum study drug level will be obtained at Day 21.
Lastly, subjects will be followed on a weekly basis by telephone for all 12 weeks of the study.
- Primary Objective: To evaluate the safety and tolerability of 21 days of subcutaneous (s.c.) once daily administration of Ang-(1-7) in eligible participants undergoing first-time, elective coronary artery bypass graft (CABG) surgery.
- Secondary Objectives:
- To determine the pharmacokinetics of 21 days of treatment with Ang-(1-7).
- To determine if 21 days of treatment with 200 mcg/kg/day of Ang-(1-7) improves memory function measured as a change in performance from baseline to follow up on a composite score comprised of memory, executive functioning, language and processing speed in Ang-(1-7) treatment group compared to placebo controls and non-surgical controls.
- To determine if treatment with 200 mcg/kg/day Ang-(1-7) decreases postoperative delirium length and severity as measured with the Confusion Assessment Method (CAM) D2 to D7 ( or discharge) after surgery as compared to treatment with placebo group.
- To determine if 21 days of treatment with 200 mcg/kg/day Ang-(1-7) improves participant self-reported outcomes using standardized Kansas City Cardiomyopathy Questionnaire (KCCQ) and Instrumental Activities of Daily Living (IADL) measurement tools.
- To determine if 21 days treatment with 200 mcg/kg/day Ang-(1-7) results in changes in suicidal ideation and behavior as assessed by The Columbia Suicide Severity Rating Scale (C-SSRS).
- To compare postoperative mortality and morbidity at 90 days in the 200 mcg/kg/day Ang-(1-7) treatment group with the placebo group.
- To determine if 21 days of treatment of 200 mcg/kg/day Ang-(1-7) decreases postoperative observable changes in brain fractional anisotropy as measured by diffuse on magnetic resonance imaging (MRI) as compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Angiotensin-(1-7) | Experimental | Drug: Angiotensin-(1-7)Intervention: Drug: 200 mcg/kg/day injected subcutaneously once daily for 21 days |
| Placebo for Angiotensin-(1-7) | Placebo comparator | Drug: Placebo for Angiotensin-(1-7)Intervention: Placebo for Angiotensin-(1-7) injected subcutaneously once daily for 21 days |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult male or female first time cardiac surgical participants
- Elective on pump coronary artery bypass grafting (CABG)
- Age 60-80
- Signed, informed consent
- Geriatric Depression Scale score less than or = 14or Beck's Depression Inventory less than or = 20
Key exclusion criteria (20 listed)
- Recent (within 60 days) Cerebrovascular disease with neurological change
- Malignancy or pre-malignant state within 5 years not including non-melanoma skin cancer
- History of liver dysfunction with ongoing sequelae (including but not limited to liver enzymes > 2.5 x upper limit or normal (ULN) at screening).
- History of renal dysfunction with ongoing sequelae (including but not limited to creatinine value > 2.5 mg/dL at screening).
- Significant Lung Disease (FEV1< 1.5 L, pO2 <70 on room air, pCO2 >45)
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 |
|---|---|---|
| Angiotensin-(1-7)Subcutaneous injection of 200 mcg/kg/day | Drug | Angiotensin-(1-7) |
| Placebo for Angiotensin-(1-7)Subcutaneous injection of Placebo | Drug | Placebo for Angiotensin-(1-7) |
Primary outcome
Demonstrate 21 days daily administration of Ang-(1-7) in participants undergoing 1st time CABG surgery is safe and efficacious as assessed by the number of related AEs grade 3 or > and change in composite neuropsychological score up to Day 90.
Time frame: Up to Day 90
Adverse events (AEs), including serious adverse events (SAEs) will be monitored from the time of enrollment through Day 90. The number of AEs, withdrawals due to AE, and withdrawals for other reasons will be tabulated. Additional assessments include: serum blood levels of the Ang-(1-7) at Day 1, Day 3, Day 5 or Discharge and Day 21. Lastly blood pressuring monitoring pre and post treatment will occur Day 1 to discharge. Change in performance on composite scores of memory, executive functioning, language and processing speed in the treatment arm compared to placebo arm and non-surgical controls measured at 3 time points will assess the effectiveness of Ang-(1-7) in reducing postoperative cognitive impairment in CABG patients.
4 secondary outcomes
Demonstrated change in the neuropsychological component scores assessed at baseline, Day 21 and Day 90 in the treatment and placebo arms.
Time frame: Up to Day 90
Evidence of change in fractional anisotropy from diffusion tensor imaging on Brain MRI at baseline versus post operative Day 21 will be assessed in the treatment and placebo arms as a measure of efficacy.
Time frame: Up to Day 21
Demonstrated change in PBR28 VT/fP, a quantitative measure of TSPO receptor density, in a composite cerebral region-of-interest (ROI) derived from brain PET imaging in the treatment and placebo arms.
Time frame: Up to Day 21
Demonstrated associations between neuropsychogical test results, MRI findings and PBR28 binding in all participants.
Time frame: Up to Day 90
Results and safety
The study was stopped early (reason given: Funding ended). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
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Coronary Artery Bypass Graft (CABG)
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.
Nancy K Sweitzer, MD, PhD principal investigator
University of Arizona
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Angiotensin-(1-7) in people with Coronary Artery Bypass Surgery and Cognitive Impairment, run by University of Arizona at 5 sites in United States.
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 6 inclusion and 20 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: stopped early, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Funding ended). Results are not available in the source record.
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?
Demonstrate 21 days daily administration of Ang-(1-7) in participants undergoing 1st time CABG surgery is safe and efficacious as assessed by the number of related AEs grade 3 or > and change in composite neuropsychological score up to Day 90. (time frame: Up to Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.