StrokeZanStrokeNCT04095806
Zanzibar Stroke Study: Narrowing the Gaps in Hypertension Care, and Improving Stroke Outcomes (ZanStroke)
An observational study of Stroke, run by Jutta Mari Adelin Jorgensen at 8 sites in Tanzania.
Trial summary
Background: A previous study in Zanzibar (which Jutta Adelin Jorgensen, PI of ZanStroke, led) showed a high prevalence of hypertension among adults at 33%, in fact higher than average in Sub-Saharan Africa (SSA), and poor performance of the health systems with nearly 90% of people with hypertension not achieving… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Stroke (exposure)
- How many people
- 869 participants
- Where
- 8 sitesTanzania
- Study dates
- 1 Oct 2019to 5 May 2022
- Phase
- Observational
- 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
Study population: All adults who get admitted to hospital in Unguja (Zanzibar) due to stroke, or develop stroke while admitted to hospital.
Who may be able to join
- admitted with a clinical diagnosis of stroke, or developing stroke while in hospital admitted for other cause (see below for stroke case definition)
- age above 18 year
- written consent form signed by patient, or authorized representative (spouse or caretaker)
- stroke onset < 30 days when enrolled
Who cannot join
- patient or authorized representative unable to understand the information given or being interviewed.
- CT scan not suspect of stroke despite clinical suspect
- Stroke case definition:
- All the following stroke categories listed below that have been submitted as the most responsible diagnosis will be included in the stroke cohort. For patients developing stroke while admitted to hospital, stroke as the second diagnosis will also be included in the cohort. Patients who previously had a stroke and are being admitted due to complications, and where stroke is not the primary diagnosis during admission, will not be included in the cohort.
- Definition of stroke ( ICD-10 classification code in parenthesis) that will be used in the study for inclusion in the cohort:
- Intracerebral hemorrhage (I61 including all sub-codes) (b) Ischemic stroke (I63 including all sub-codes, H34.1) (c) Stroke, not specified as hemorrhagic or ischemic (I64) (d) Cerebral Venous Thrombosis, non-pyogenic (I63.6) Where CTscan is not available, the clinical diagnosis of stroke will be used, and coding will be I64 (ICD-10)
- -
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Tanzania8 sites
Kivunge District Hospital
Kinyasini, Zanzibar
Mnazi Mmoja Hospital
Zanzibar, 236
Al Rahma Hospital
Zanzibar
Bububu Military Hospital
Zanzibar
KMKM hospital Bububu
Zanzibar
Makunduchi District hospital
Zanzibar
Tasakthaa Global Hospital
Zanzibar
Tawakala hospital
Zanzibar
About this study
Official title: Zanzibar Stroke Study. Using a Prospective Register-based Study, Qualitative Research, and Economic Analysis to Support Evidence Synthesis for Health Policy and System Change in Zanzibar, Tanzania.
Background:
A previous study in Zanzibar (which Jutta Adelin Jorgensen, PI of ZanStroke, led) showed a high prevalence of hypertension among adults at 33%, in fact higher than average in Sub-Saharan Africa (SSA), and poor performance of the health systems with nearly 90% of people with hypertension not achieving adequate blood pressure control. Uncontrolled hypertension (HTN) and stroke have already become among the commonest causes of admission to and death at hospital in Zanzibar. At the same time, there is little or no data available to quantify the stroke burden on types, treatment and outcomes, cost of stroke care, nor a comprehensive understanding of the causes of poor hypertension control in the population.The Tanzanian Stroke Incidence study (which Richard Walker from Newcastle University led) showed some of the highest stroke incidence rates in the world. However, there are many unanswered questions, and the Zanzibar Stroke Study will be a unique opportunity to look at all stroke admissions from a large island population.
Read more
Zanzibar Stroke Study:
The hypotheses investigated are
1a. Current challenges in stroke care cannot exclusively be explained by limited structural resources, and care delivering processes play an essential role.
- b. Current organization and quality of care for stroke including rehabilitation could benefit from being aligned with best practices for low resource settings.
- a. Stroke types, causes, and prognosis are dominated by a higher proportion of hemorrhagic strokes, associated to poorly controlled hypertension, higher 30-day mortality, and worse prognosis in terms of disability and mortality at 12 months than seen in high income settings.
2b Long term stroke outcome is not only depending on stroke severity but also on sociodemographic/economic factors with worse prognosis for the poorest part of the population.
3a. There is a significant first stage delay due to local perceptions and beliefs around stroke which prohibits biomedical treatment in the prognostically important acute phase of stroke 3b. There are untapped resources in the community that could be leveraged to increase adherence to medical treatment to control BP to prevent stroke and re-stroke, as well as making rehabilitation accessible 4a. Introducing a hypertension care package at lowest primary care level for people at high cardiovascular disease (CVD) risk to prevent stroke and re-stroke is cost-effective, affordable, and possible.
4b. With no intervention, the cost of stroke care at hospital level will in 10 years exceed the cost of all reproductive and child health (RCH) services.
ZanStroke is an observational, prospective study of stroke admissions to hospitals in Zanzibar (Unguja) enrolling all patients with a recent stroke (< 30 days) over a period of one year to investigate the burden of stroke disease, risk factors and outcome up till 12 months post-stroke. This will be done through establishing a stroke patient register.
Participant data will include sociodemographic and -economic information, vascular risk factors and previous medical history, routine head-CT, routine biochemical results and other investigations, as well as early and long-term outcomes (deaths, disability, independence/functionality, quality of life, cognition, medicine adherence, rehabilitation therapy, re-stroke).
Approximately 80% of stroke patients in Unguja, Zanzibar who seek hospital care are admitted to the main hospital and the nearby private hospital, and these will undergo CT head scan, but this will not be possible in all of the other six hospitals. We will take blood samples and store serum and deoxyribonucleic acid (DNA) for potential future analysis from the main hospital and the nearby private hospital only.
In addition to the clinical epidemiological research, qualitative and health economic evaluation research will be undertaken to understand stroke patients and caretakers life worlds and perspectives, health care providers skills and practices, organization and processes of stroke care at hospital level, and to define a set of most cost-effective interventions to prevent and treat stroke in the particular Zanzibar context.
Read the detailed description
Current and future benefits and impacts:
With the demographic transition and population ageing in SSA rates of stroke are set to continue to increase rapidly as part of the double burden of disease (still a major burden of infectious diseases, as well as an unfinished agenda of maternal and newborn health).
Previous studies have already established a global high level of hypertension in the adult population in Zanzibar, and low performance of the health system for managing this.
It is important to identify the peculiar genomic, gene-environmental and environmental risk and protective factors for stroke occurrence, pattern, type, outcome, and current incidence velocity in SSA in order to inform preventive measures especially effective and cost-effective control of raised blood pressure/hypertension; the best model for the provision of inpatient care and rehabilitation in a resource poor environment with lack of access to dedicated stroke units and limited multidisciplinary team input; and to include the particular East Africa population in existing or future international stroke collaborations to ensure that genetic variations relevant to the population there are represented.
- Conditions
- Stroke
- Being tested
- Stroke (exposure)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stroke (exposure)Other
stroke case definition (exposure) listed in inclusion/exclusion criteria section
What is being measured
The primary outcome is the main question the study is designed to answer.
30 day mortality
Mortality rate of stroke patients 30 days post stroke
Measured: 30 days post stroke; data collected over 12 months
90 days mortality
Mortality rate of stroke patients 90 days post stroke
Measured: 90 days post stroke; data collected over 12 months
12 months mortality
Mortality rate of stroke patients 12 months post stroke
Measured: 12 months post stroke; data collected over 12 months
Secondary outcomes (6)
Disability at 30 days
disability of stroke patients as measured using the modified Ranking Scale (mRS) at 30 days post stroke.
The modified Rankin Scale (mRS) assesses disability in patients who have suffered a stroke and is compared over time to check for recovery and degree of continued disability. A score of 0 is no disability, 5 is disability requiring constant care for all needs; 6 is death.
The mRS has been used in clinical research for over 30 years and is a common standard for assessing functional outcomes in patients with stroke.
Multiple studies have shown that the mRS correlates with physiological indicators such as stroke type, lesion size and neurological impairment as assessed by other stroke evaluation scale
Measured: 30 days post stroke; data collected over 12 months
Disability at 12 months
disability of stroke patients as measured using modified Rankin Scale (mRS) at 12 months post stroke. The modified Rankin Scale (mRS) assesses disability in patients who have suffered a stroke and is compared over time to check for recovery and degree of continued disability. A score of 0 is no disability, 5 is disability requiring constant care for all needs; 6 is death.
The mRS has been used in clinical research for over 30 years and is a common standard for assessing functional outcomes in patients with stroke.
Multiple studies have shown that the mRS correlates with physiological indicators such as stroke type, lesion size and neurological impairment as assessed by other stroke evaluation scale
Measured: 12 months post stroke; data collected over 12 months
Cognitive impairment at 3 and 12 months
Cognitive impairment of stroke patients 3 and 12 months post stroke using the Identification and Intervention for Dementia in Elderly Africans (IDEA) cognitive screening tool .
The first 4 items involve being able to name a bridge from a description of its use, knowing the day of the week, knowing the name of the village chief/ town mayor/ city governor and naming as many animals as possible in one minute (score 2 for ≥ 8 animals, score 1 for 4-7 animals, score 0 for 0-3 animals). Item 5 is a 10-word recall test (score 1 point for each word up to a maximum of 5 points). The sixth item is designed to measure praxis and involves a matchstick design test with scores ranging from 0 (no matchsticks placed correctly), to 3 (all four matchsticks placed correctly).
The maximum possible score is 15 and the minimum 0, with a higher score indicating better cognitive function. 7/8 is used as a cut-off for dementia, and 10/11 a cut-off for cognitive impairment
Measured: 3 and 12 months post stroke; data collected over 12 months
Health related Quality of Life at 3 and 12 months
Quality of life among stroke patients 3 and 12 months post stroke using the 5-level EQ-5D instrument.
The EQ-5D is a standardized non-disease specific instrument to describe and value health-related quality of life and consist of a descriptive system and a visual analogue scale (VAS).
The descriptive system comprises of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels. The patient indicates his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale ( 0-10), where the endpoints are labelled 'The best health you can imagine' (0) and 'The worst health you can imagine' (10).
Measured: 3 and 12 months post stroke; data collected over 12 months
Medicine Adherence at 3 and 12 months
Medicine adherence among stroke patients 3 and 12 months post stroke using the Medicine Adherence Questionnaire (MAQ).
MAQ is a standardized instrument to assess intentional and un-intentional non-adherence and consist of four questions with response options yes or no. No to all responses = good adherence, while one or more Yes to responses = non-adherent. Non-adherence can be identified as mainly unintentional (factor 1) or purposeful (factor 2), or mixed.
Measured: 3 and 12 months post stroke; data collected over 12 months
Re-stroke at 12 months
proportion of stroke patients who experience a new stroke within 12 months of previous stroke
Measured: 12 months post stroke; data collected over 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start1 Oct 2019
- Primary completion1 Oct 2021
- Study completion5 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 869 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jutta Mari Adelin Jorgensen
- Sponsor type
- University, hospital or other
- Collaborators
- Newcastle University, Vervig (IoM)
- Responsible party
- Sponsor-investigator, Jutta Mari Adelin Jorgensen, Mnazi Mmoja National Referral Hospital
- Investigators
- Jutta A Jorgensen, MD, Principal investigator, Mnazi Mmoja Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095806
- Sponsor's protocol ID
- ZAHREC/02/July/2019/47
- Acronym
- ZanStroke
- Status last verified
- May 2022
- First submitted
- 18 Sep 2019
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jorgensen JA, Matuja SS. Establishing Stroke Registers in Sub-Saharan Africa: Experiences From 2 Large Referral Hospitals in Tanzania. Stroke. 2023 Sep;54(9):e417-e418. doi: 10.1161/STROKEAHA.123.043627. Epub 2023 Jul 14. No abstract available.
PubMed 37449421Jorgensen JMA, Christensen DL, Nielsen KK, Sadiq HS, Khan MY, Jusabani AM, Walker R. Incidence and characteristics of stroke in Zanzibar-a hospital-based prospective study in a low-income island population. Front Neurol. 2022 Jul 28;13:931915. doi: 10.3389/fneur.2022.931915. eCollection 2022.
PubMed 35968303
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zanzibar Stroke Study. Using a Prospective Register-based Study, Qualitative Research, and Economic Analysis to Support Evidence Synthesis for Health Policy and System Change in Zanzibar, Tanzania.
- ClinicalTrials.gov ID
- NCT04095806
- Acronym / sponsor ID
- ZanStroke / ZAHREC/02/July/2019/47
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 869 participants (actual)
- Lead sponsor
- Jutta Mari Adelin JorgensenUniversity, hospital or other
- Collaborators
- Newcastle University, Vervig (IoM)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 5 May 2022 (actual)
- First posted
- 19 Sep 2019 (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.
Background:
A previous study in Zanzibar (which Jutta Adelin Jorgensen, PI of ZanStroke, led) showed a high prevalence of hypertension among adults at 33%, in fact higher than average in Sub-Saharan Africa (SSA), and poor performance of the health systems with nearly 90% of people with hypertension not achieving adequate blood pressure control. Uncontrolled hypertension (HTN) and stroke have already become among the commonest causes of admission to and death at hospital in Zanzibar. At the same time, there is little or no data available to quantify the stroke burden on types, treatment and outcomes, cost of stroke care, nor a comprehensive understanding of the causes of poor hypertension control in the population.The Tanzanian Stroke Incidence study (which Richard Walker from Newcastle University led) showed some of the highest stroke incidence rates in the world. However, there are many unanswered questions, and the Zanzibar Stroke Study will be a unique opportunity to look at all stroke admissions from a large island population.
Zanzibar Stroke Study:
The hypotheses investigated are
1a. Current challenges in stroke care cannot exclusively be explained by limited structural resources, and care delivering processes play an essential role.
- b. Current organization and quality of care for stroke including rehabilitation could benefit from being aligned with best practices for low resource settings.
- a. Stroke types, causes, and prognosis are dominated by a higher proportion of hemorrhagic strokes, associated to poorly controlled hypertension, higher 30-day mortality, and worse prognosis in terms of disability and mortality at 12 months than seen in high income settings.
2b Long term stroke outcome is not only depending on stroke severity but also on sociodemographic/economic factors with worse prognosis for the poorest part of the population.
3a. There is a significant first stage delay due to local perceptions and beliefs around stroke which prohibits biomedical treatment in the prognostically important acute phase of stroke 3b. There are untapped resources in the community that could be leveraged to increase adherence to medical treatment to control BP to prevent stroke and re-stroke, as well as making rehabilitation accessible 4a. Introducing a hypertension care package at lowest primary care level for people at high cardiovascular disease (CVD) risk to prevent stroke and re-stroke is cost-effective, affordable, and possible.
4b. With no intervention, the cost of stroke care at hospital level will in 10 years exceed the cost of all reproductive and child health (RCH) services.
ZanStroke is an observational, prospective study of stroke admissions to hospitals in Zanzibar (Unguja) enrolling all patients with a recent stroke (< 30 days) over a period of one year to investigate the burden of stroke disease, risk factors and outcome up till 12 months post-stroke. This will be done through establishing a stroke patient register.
Participant data will include sociodemographic and -economic information, vascular risk factors and previous medical history, routine head-CT, routine biochemical results and other investigations, as well as early and long-term outcomes (deaths, disability, independence/functionality, quality of life, cognition, medicine adherence, rehabilitation therapy, re-stroke).
Approximately 80% of stroke patients in Unguja, Zanzibar who seek hospital care are admitted to the main hospital and the nearby private hospital, and these will undergo CT head scan, but this will not be possible in all of the other six hospitals. We will take blood samples and store serum and deoxyribonucleic acid (DNA) for potential future analysis from the main hospital and the nearby private hospital only.
In addition to the clinical epidemiological research, qualitative and health economic evaluation research will be undertaken to understand stroke patients and caretakers life worlds and perspectives, health care providers skills and practices, organization and processes of stroke care at hospital level, and to define a set of most cost-effective interventions to prevent and treat stroke in the particular Zanzibar context.
Detailed description
Current and future benefits and impacts:
With the demographic transition and population ageing in SSA rates of stroke are set to continue to increase rapidly as part of the double burden of disease (still a major burden of infectious diseases, as well as an unfinished agenda of maternal and newborn health).
Previous studies have already established a global high level of hypertension in the adult population in Zanzibar, and low performance of the health system for managing this.
It is important to identify the peculiar genomic, gene-environmental and environmental risk and protective factors for stroke occurrence, pattern, type, outcome, and current incidence velocity in SSA in order to inform preventive measures especially effective and cost-effective control of raised blood pressure/hypertension; the best model for the provision of inpatient care and rehabilitation in a resource poor environment with lack of access to dedicated stroke units and limited multidisciplinary team input; and to include the particular East Africa population in existing or future international stroke collaborations to ensure that genetic variations relevant to the population there are represented.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults who get admitted to hospital in Unguja (Zanzibar) due to stroke, or develop stroke while admitted to hospital.
Key inclusion criteria (4 listed)
- admitted with a clinical diagnosis of stroke, or developing stroke while in hospital admitted for other cause (see below for stroke case definition)
- age above 18 year
- written consent form signed by patient, or authorized representative (spouse or caretaker)
- stroke onset < 30 days when enrolled
Key exclusion criteria (7 listed)
- patient or authorized representative unable to understand the information given or being interviewed.
- CT scan not suspect of stroke despite clinical suspect
- All the following stroke categories listed below that have been submitted as the most responsible diagnosis will be included in the stroke cohort. For patients developing stroke while admitted to hospital, stroke as the second diagnosis will also be included in the cohort. Patients who previously had a stroke and are being admitted due to complications, and where stroke is not the primary diagnosis during admission, will not be included in the cohort.
- Definition of stroke ( ICD-10 classification code in parenthesis) that will be used in the study for inclusion in the cohort:
- Intracerebral hemorrhage (I61 including all sub-codes) (b) Ischemic stroke (I63 including all sub-codes, H34.1) (c) Stroke, not specified as hemorrhagic or ischemic (I64) (d) Cerebral Venous Thrombosis, non-pyogenic (I63.6) Where CTscan is not available, the clinical diagnosis of stroke will be used, and coding will be I64 (ICD-10)
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 |
|---|---|---|
| Stroke (exposure)stroke case definition (exposure) listed in inclusion/exclusion criteria section | Other | – |
Primary outcome
30 day mortality
Time frame: 30 days post stroke; data collected over 12 months
Mortality rate of stroke patients 30 days post stroke
90 days mortality
Time frame: 90 days post stroke; data collected over 12 months
Mortality rate of stroke patients 90 days post stroke
12 months mortality
Time frame: 12 months post stroke; data collected over 12 months
Mortality rate of stroke patients 12 months post stroke
6 secondary outcomes
Disability at 30 days
Time frame: 30 days post stroke; data collected over 12 months
Disability at 12 months
Time frame: 12 months post stroke; data collected over 12 months
Cognitive impairment at 3 and 12 months
Time frame: 3 and 12 months post stroke; data collected over 12 months
Health related Quality of Life at 3 and 12 months
Time frame: 3 and 12 months post stroke; data collected over 12 months
Medicine Adherence at 3 and 12 months
Time frame: 3 and 12 months post stroke; data collected over 12 months
Re-stroke at 12 months
Time frame: 12 months post stroke; data collected over 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
- Derived from this study: PubMed 37449421Jorgensen JA, Matuja SS. Establishing Stroke Registers in Sub-Saharan Africa: Experiences From 2 Large Referral Hospitals in Tanzania. Stroke. 2023 Sep;54(9):e417-e418. doi: 10.1161/STROKEAHA.123.043627. Epub 2023 Jul 14. No abstract available.
- Derived from this study: PubMed 35968303Jorgensen JMA, Christensen DL, Nielsen KK, Sadiq HS, Khan MY, Jusabani AM, Walker R. Incidence and characteristics of stroke in Zanzibar-a hospital-based prospective study in a low-income island population. Front Neurol. 2022 Jul 28;13:931915. doi: 10.3389/fneur.2022.931915. eCollection 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jutta A Jorgensen, MD principal investigator
Mnazi Mmoja Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Jutta Mari Adelin Jorgensen at 8 sites in Tanzania.
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 4 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: finished, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Tanzania. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
30 day mortality (time frame: 30 days post stroke; data collected over 12 months). The study lists 3 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 NCT04095806, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2022.