Cerebral InfarctionNCT05817097
Effect of Dipeptidyl-4 Inhibitors in Reducing Stroke Severity, From HIRA Database
An observational study of Cerebral Infarction and Infarction, Brain, run by Ajou University School of Medicine.
Trial summary
The goal of this observational study is to compare severity and mortality rates of acute cerebral infarction(requiring thrombolysis or endovascular recanalization) depending on the type of oral antidiabetic drug taken before the onset of cerebral infarction. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cerebral Infarction, Infarction, Brain, Dipeptidyl-Peptidase IV Inhibitors
- What is being tested?
- Dipeptidyl peptidase-4 inhibitor
- How many people
- 22,119 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to 30 Dec 2024
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a retrospective study using the Health Insurance Review and Assessment Service (HIRA) database in Korea. In this database, patients with acute cerebral infarction who underwent thrombolysis(intravenous thrombolysis) or endovascular recanalization (intraarterial thrombectomy) between 2014 and 2021 is included.
Who may be able to join
- Patients with acute cerebral infarction who underwent thrombolysis or endovascular recanalization in Korea between 2014 and 2021
- Those who have been previously diagnosed with diabetes and are taking oral anti-diabetic drugs
- Adult (over 19 years of age)
- The definition of antidiabetic drug use is defined as a case in which an antidiabetic drug was prescribed for at least 2 months before stroke and the duration of treatment for stroke coincided with the prescribed duration of the drug.
Who cannot join
- Patients taking insulin to control diabetes
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Dipeptidyl-4 Inhibitors in Reducing Stroke Severity, From the Health Insurance Review and Assessment Service Database
The goal of this observational study is to compare severity and mortality rates of acute cerebral infarction(requiring thrombolysis or endovascular recanalization) depending on the type of oral antidiabetic drug taken before the onset of cerebral infarction.
Researchers will compare the group that used DPP-4 inhibitors as anti-diabetic drugs before cerebral infarction and the group that did not use them to see the effect of DPP-4 inhibitors in reducing severity of cerebral infarction.
Read the detailed description
This is a retrospective study to see the effects of reducing the severity of cerebral infarction(requiring thrombolysis or endovascular recanalization) of DPP-4 inhibitors by comparing the survival rate after acute cerebral infarction hospitalization, discharge rate to home, and medical cost.
- Severity of cerebral infarction and poor prognosis is mainly associated with hyperglycemia caused by diabetes, which increases the Infarction volume and hemorrhagic trasformation.
- However, the effect of loergin blood glucose on reducing the Infarction volume and improving prognosis of cerebral infarction has not been proven.
- Preclinical studies have demonstrated a anti-stroke effect that reduces the Infarction volume using certain anti-diabetic drugs.
- Therefore, there is a possibility that certain anti-diabetic drugs may reduce the severity of cerebral infarction as a class effect in addition to the effect of blood sugar control.
- This is particularly likely to exist in the DPP-4 inhibitor family identified through preclinical studies.
- Being tested
- Dipeptidyl peptidase-4 inhibitor
- Keywords
- Dipeptidyl-Peptidase IV Inhibitors, Antidiabetic Drug
- Medical subject headings
- Cerebral Infarction, Brain Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dipeptidyl peptidase-4 inhibitorDrug
Also called A10BH07, EVOGLIPTIN, Suganon Tab
The definition of antidiabetic drug use is defined as a case in which an antidiabetic drug was prescribed for at least 2 months before stroke and the duration of treatment for stroke coincided with the prescribed duration of the drug.
| Study group | Role | What they receive |
|---|---|---|
| DPP4i | used DPP-4 inhibitors as anti-diabetic drugs before cerebral infarction(requiring thrombolysis or endovascular recanalization) Combination therpay is acceptable. Receives: Drug: Dipeptidyl peptidase-4 inhibitor | |
| except DPP4i | patients that did not use DPP-4 inhibitors as anti-diabetic drugs before cerebral infarction(requiring thrombolysis or endovascular recanalization) |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year survival rate
The survival rates of the DPP-4 inhibitor group and the non-use group are compared 1 year after the onset of severe stroke.
Measured: Check the data one year after the onset of stroke.
90-day survival rate
The survival rates of the DPP-4 inhibitor group and the non-use group are compared 90-day after the onset of severe stroke.
Measured: Check the data 90-day after the onset of stroke.
re-hospitalization
The re-hospitalization rates of the DPP-4 inhibitor group and the non-use group are compared after the onset of severe stroke.
Measured: 1 year after discharge the stroke treatment.
frequency of cerebral hemorrhage
The frequency of cerebral hemorrhage rates of the DPP-4 inhibitor group and the non-use group are compared after the onset of severe stroke.
Measured: Hospitalization period and 1 year after discharge the stroke treatment.
Rate of Intensive care unit treatment
The Intensive care unit treatment rate of the DPP-4 inhibitor group and the non-use group are compared.
Measured: Hospitalization period is expected to be up to three months. It is not possible to accurately estimate the period of hospitalization due to severe stroke.
Duration of Intensive care unit
The duration of Intensive care unit of the DPP-4 inhibitor group and the non-use group are compared.
Measured: Hospitalization period is expected to be up to three months. It is not possible to accurately estimate the period of hospitalization due to severe stroke.
Rate of Stroke care unit treatment
The Stroke care unit treatment rate of the DPP-4 inhibitor group and the non-use group are compared.
Measured: Hospitalization period is expected to be up to three months. It is not possible to accurately estimate the period of hospitalization due to severe stroke.
Duration of Stroke care unit
The duration of Stroke care unit of the DPP-4 inhibitor group and the non-use group are compared.
Measured: Hospitalization period is expected to be up to three months. It is not possible to accurately estimate the period of hospitalization due to severe stroke.
tracheal intubation period
The tracheal intubation period of the DPP-4 inhibitor group and the non-use group are compared.
Measured: Hospitalization period is expected to be up to three months. It is not possible to accurately estimate the period of hospitalization due to severe stroke.
total hospitalization days
The total hospitalization days of the DPP-4 inhibitor group and the non-use group are compared.
Measured: Hospitalization period is expected to be up to three months. It is not possible to accurately estimate the period of hospitalization due to severe stroke.
medical expenses incurred at the time of hospitalization
The medical expenses incurred at the time of hospitalization of the DPP-4 inhibitor group and the non-use group are compared.
Measured: Hospitalization period is expected to be up to three months. It is not possible to accurately estimate the period of hospitalization due to severe stroke.
Secondary outcomes (2)
Home discharge rate
The Home discharge rate of the DPP-4 inhibitor group and the non-use group are compared.
Measured: At the end of discharge from stroke treatment.
medical expenses after discharge from hospital
The medical expenses after discharge from hospital of the DPP-4 inhibitor group and the non-use group are compared.
Measured: 1 year after discharge the stroke treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study startAug 2023 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cerebral InfarctionStudies 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
- Retrospective
- Enrolment
- 22,119 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Dong-A ST Co., Ltd.
- Responsible party
- Principal investigator, Seong-Joon Lee, Ajou University School of Medicine
- Investigators
- DukYong Yoon, MD., PhD., Principal investigator, Department of Biomedical Systems Informatics,Yonsei University College of Medicine,Yongin,SouthKoreaSeong-Joon Lee, MD., PhD., Principal investigator, Department of Neurology, Ajou University School of Medicine, Suwon, South Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817097
- Sponsor's protocol ID
- AJOUIRB-EX-2023-089
- Status last verified
- Jul 2023
- First submitted
- 8 Mar 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Ajou University Hospital's IRB(Institutional Review Board) sends IRB approval documents to HIRA and conducts research with anonymized data after request. Data collected during the research process will be stored for 3 years and then properly disposed of in accordance with relevant laws.
Publications
Sinha B, Ghosal S. Meta-analyses of the effects of DPP-4 inhibitors, SGLT2 inhibitors and GLP1 receptor analogues on cardiovascular death, myocardial infarction, stroke and hospitalization for heart failure. Diabetes Res Clin Pract. 2019 Apr;150:8-16. doi: 10.1016/j.diabres.2019.02.014. Epub 2019 Feb 20.
PubMed 30794833Darsalia V, Ortsater H, Olverling A, Darlof E, Wolbert P, Nystrom T, Klein T, Sjoholm A, Patrone C. The DPP-4 inhibitor linagliptin counteracts stroke in the normal and diabetic mouse brain: a comparison with glimepiride. Diabetes. 2013 Apr;62(4):1289-96. doi: 10.2337/db12-0988. Epub 2012 Dec 3.
PubMed 23209191Lee SJ, Yoon BS, Hong JM, Joe EH, Lee JS. Effects of co-administration of metformin and evogliptin on cerebral infarct volume in the diabetic rat. Exp Neurol. 2022 Feb;348:113922. doi: 10.1016/j.expneurol.2021.113922. Epub 2021 Nov 12.
PubMed 34780772Johnston KC, Bruno A, Pauls Q, Hall CE, Barrett KM, Barsan W, Fansler A, Van de Bruinhorst K, Janis S, Durkalski-Mauldin VL; Neurological Emergencies Treatment Trials Network and the SHINE Trial Investigators. Intensive vs Standard Treatment of Hyperglycemia and Functional Outcome in Patients With Acute Ischemic Stroke: The SHINE Randomized Clinical Trial. JAMA. 2019 Jul 23;322(4):326-335. doi: 10.1001/jama.2019.9346.
PubMed 31334795Kim JY, Kang K, Kang J, Koo J, Kim DH, Kim BJ, Kim WJ, Kim EG, Kim JG, Kim JM, Kim JT, Kim C, Nah HW, Park KY, Park MS, Park JM, Park JH, Park TH, Park HK, Seo WK, Seo JH, Song TJ, Ahn SH, Oh MS, Oh HG, Yu S, Lee KJ, Lee KB, Lee K, Lee SH, Lee SJ, Jang MU, Chung JW, Cho YJ, Choi KH, Choi JC, Hong KS, Hwang YH, Kim SE, Lee JS, Choi J, Kim MS, Kim YJ, Seok J, Jang S, Han S, Han HW, Hong JH, Yun H, Lee J, Bae HJ. Executive Summary of Stroke Statistics in Korea 2018: A Report from the Epidemiology Research Council of the Korean Stroke Society. J Stroke. 2019 Jan;21(1):42-59. doi: 10.5853/jos.2018.03125. Epub 2018 Dec 18.
PubMed 30558400Park SH, Jeong HE, Oh IS, Hong SM, Yu SH, Lee CB, Shin JY. Cardiovascular safety of evogliptin in patients with type 2 diabetes: A nationwide cohort study. Diabetes Obes Metab. 2021 Jun;23(6):1232-1241. doi: 10.1111/dom.14330. Epub 2021 Feb 10.
PubMed 33502058Shim DH, Kim Y, Roh J, Kang J, Park KP, Cha JK, Baik SK, Kim Y. Hospital Volume Threshold Associated with Higher Survival after Endovascular Recanalization Therapy for Acute Ischemic Stroke. J Stroke. 2020 Jan;22(1):141-149. doi: 10.5853/jos.2019.00955. Epub 2020 Jan 31.
PubMed 32027799
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dipeptidyl-4 Inhibitors in Reducing Stroke Severity, From the Health Insurance Review and Assessment Service Database
- ClinicalTrials.gov ID
- NCT05817097
- Acronym / sponsor ID
- AJOUIRB-EX-2023-089
- Keywords
- Dipeptidyl-Peptidase IV Inhibitors, Antidiabetic Drug
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 22,119 participants (estimated)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Collaborators
- Dong-A ST Co., Ltd.
- Study start
- Aug 2023 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 18 Apr 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.
The goal of this observational study is to compare severity and mortality rates of acute cerebral infarction(requiring thrombolysis or endovascular recanalization) depending on the type of oral antidiabetic drug taken before the onset of cerebral infarction.
Researchers will compare the group that used DPP-4 inhibitors as anti-diabetic drugs before cerebral infarction and the group that did not use them to see the effect of DPP-4 inhibitors in reducing severity of cerebral infarction.
Detailed description
This is a retrospective study to see the effects of reducing the severity of cerebral infarction(requiring thrombolysis or endovascular recanalization) of DPP-4 inhibitors by comparing the survival rate after acute cerebral infarction hospitalization, discharge rate to home, and medical cost.
- Severity of cerebral infarction and poor prognosis is mainly associated with hyperglycemia caused by diabetes, which increases the Infarction volume and hemorrhagic trasformation.
- However, the effect of loergin blood glucose on reducing the Infarction volume and improving prognosis of cerebral infarction has not been proven.
- Preclinical studies have demonstrated a anti-stroke effect that reduces the Infarction volume using certain anti-diabetic drugs.
- Therefore, there is a possibility that certain anti-diabetic drugs may reduce the severity of cerebral infarction as a class effect in addition to the effect of blood sugar control.
- This is particularly likely to exist in the DPP-4 inhibitor family identified through preclinical studies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DPP4i | – | Drug: Dipeptidyl peptidase-4 inhibitorused DPP-4 inhibitors as anti-diabetic drugs before cerebral infarction(requiring thrombolysis or endovascular recanalization) Combination therpay is acceptable. |
| except DPP4i | – | –patients that did not use DPP-4 inhibitors as anti-diabetic drugs before cerebral infarction(requiring thrombolysis or endovascular recanalization) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a retrospective study using the Health Insurance Review and Assessment Service (HIRA) database in Korea. In this database, patients with acute cerebral infarction who underwent thrombolysis(intravenous thrombolysis) or endovascular recanalization (intraarterial thrombectomy) between 2014 and 2021 is included.
Key inclusion criteria (4 listed)
- Patients with acute cerebral infarction who underwent thrombolysis or endovascular recanalization in Korea between 2014 and 2021
- Those who have been previously diagnosed with diabetes and are taking oral anti-diabetic drugs
- Adult (over 19 years of age)
Key exclusion criteria (1 listed)
- Patients taking insulin to control diabetes
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 |
|---|---|---|
| Dipeptidyl peptidase-4 inhibitorAlso: A10BH07, EVOGLIPTIN, Suganon TabThe definition of antidiabetic drug use is defined as a case in which an antidiabetic drug was prescribed for at least 2 months before stroke and the duration of treatment for stroke coincided with the prescribed duration of the drug. | Drug | DPP4i |
Primary outcome
1-year survival rate
Time frame: Check the data one year after the onset of stroke.
The survival rates of the DPP-4 inhibitor group and the non-use group are compared 1 year after the onset of severe stroke.
90-day survival rate
Time frame: Check the data 90-day after the onset of stroke.
The survival rates of the DPP-4 inhibitor group and the non-use group are compared 90-day after the onset of severe stroke.
re-hospitalization
Time frame: 1 year after discharge the stroke treatment.
The re-hospitalization rates of the DPP-4 inhibitor group and the non-use group are compared after the onset of severe stroke.
frequency of cerebral hemorrhage
Time frame: Hospitalization period and 1 year after discharge the stroke treatment.
The frequency of cerebral hemorrhage rates of the DPP-4 inhibitor group and the non-use group are compared after the onset of severe stroke.
Rate of Intensive care unit treatment
Time frame: Hospitalization period is expected to be up to three months. It is not possible to accurately estimate the period of hospitalization due to severe stroke.
The Intensive care unit treatment rate of the DPP-4 inhibitor group and the non-use group are compared.
Duration of Intensive care unit
Time frame: Hospitalization period is expected to be up to three months. It is not possible to accurately estimate the period of hospitalization due to severe stroke.
The duration of Intensive care unit of the DPP-4 inhibitor group and the non-use group are compared.
Rate of Stroke care unit treatment
Time frame: Hospitalization period is expected to be up to three months. It is not possible to accurately estimate the period of hospitalization due to severe stroke.
The Stroke care unit treatment rate of the DPP-4 inhibitor group and the non-use group are compared.
Duration of Stroke care unit
Time frame: Hospitalization period is expected to be up to three months. It is not possible to accurately estimate the period of hospitalization due to severe stroke.
The duration of Stroke care unit of the DPP-4 inhibitor group and the non-use group are compared.
tracheal intubation period
Time frame: Hospitalization period is expected to be up to three months. It is not possible to accurately estimate the period of hospitalization due to severe stroke.
The tracheal intubation period of the DPP-4 inhibitor group and the non-use group are compared.
total hospitalization days
Time frame: Hospitalization period is expected to be up to three months. It is not possible to accurately estimate the period of hospitalization due to severe stroke.
The total hospitalization days of the DPP-4 inhibitor group and the non-use group are compared.
medical expenses incurred at the time of hospitalization
Time frame: Hospitalization period is expected to be up to three months. It is not possible to accurately estimate the period of hospitalization due to severe stroke.
The medical expenses incurred at the time of hospitalization of the DPP-4 inhibitor group and the non-use group are compared.
2 secondary outcomes
Home discharge rate
Time frame: At the end of discharge from stroke treatment.
medical expenses after discharge from hospital
Time frame: 1 year after discharge the stroke treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Results publication: PubMed 30794833Sinha B, Ghosal S. Meta-analyses of the effects of DPP-4 inhibitors, SGLT2 inhibitors and GLP1 receptor analogues on cardiovascular death, myocardial infarction, stroke and hospitalization for heart failure. Diabetes Res Clin Pract. 2019 Apr;150:8-16. doi: 10.1016/j.diabres.2019.02.014. Epub 2019 Feb 20.
- Results publication: PubMed 23209191Darsalia V, Ortsater H, Olverling A, Darlof E, Wolbert P, Nystrom T, Klein T, Sjoholm A, Patrone C. The DPP-4 inhibitor linagliptin counteracts stroke in the normal and diabetic mouse brain: a comparison with glimepiride. Diabetes. 2013 Apr;62(4):1289-96. doi: 10.2337/db12-0988. Epub 2012 Dec 3.
- Results publication: PubMed 34780772Lee SJ, Yoon BS, Hong JM, Joe EH, Lee JS. Effects of co-administration of metformin and evogliptin on cerebral infarct volume in the diabetic rat. Exp Neurol. 2022 Feb;348:113922. doi: 10.1016/j.expneurol.2021.113922. Epub 2021 Nov 12.
- Results publication: PubMed 31334795Johnston KC, Bruno A, Pauls Q, Hall CE, Barrett KM, Barsan W, Fansler A, Van de Bruinhorst K, Janis S, Durkalski-Mauldin VL; Neurological Emergencies Treatment Trials Network and the SHINE Trial Investigators. Intensive vs Standard Treatment of Hyperglycemia and Functional Outcome in Patients With Acute Ischemic Stroke: The SHINE Randomized Clinical Trial. JAMA. 2019 Jul 23;322(4):326-335. doi: 10.1001/jama.2019.9346.
- Results publication: PubMed 30558400Kim JY, Kang K, Kang J, Koo J, Kim DH, Kim BJ, Kim WJ, Kim EG, Kim JG, Kim JM, Kim JT, Kim C, Nah HW, Park KY, Park MS, Park JM, Park JH, Park TH, Park HK, Seo WK, Seo JH, Song TJ, Ahn SH, Oh MS, Oh HG, Yu S, Lee KJ, Lee KB, Lee K, Lee SH, Lee SJ, Jang MU, Chung JW, Cho YJ, Choi KH, Choi JC, Hong KS, Hwang YH, Kim SE, Lee JS, Choi J, Kim MS, Kim YJ, Seok J, Jang S, Han S, Han HW, Hong JH, Yun H, Lee J, Bae HJ. Executive Summary of Stroke Statistics in Korea 2018: A Report from the Epidemiology Research Council of the Korean Stroke Society. J Stroke. 2019 Jan;21(1):42-59. doi: 10.5853/jos.2018.03125. Epub 2018 Dec 18.
- Results publication: PubMed 33502058Park SH, Jeong HE, Oh IS, Hong SM, Yu SH, Lee CB, Shin JY. Cardiovascular safety of evogliptin in patients with type 2 diabetes: A nationwide cohort study. Diabetes Obes Metab. 2021 Jun;23(6):1232-1241. doi: 10.1111/dom.14330. Epub 2021 Feb 10.
- Results publication: PubMed 32027799Shim DH, Kim Y, Roh J, Kang J, Park KP, Cha JK, Baik SK, Kim Y. Hospital Volume Threshold Associated with Higher Survival after Endovascular Recanalization Therapy for Acute Ischemic Stroke. J Stroke. 2020 Jan;22(1):141-149. doi: 10.5853/jos.2019.00955. Epub 2020 Jan 31.
- Individual participant dataSharing planned: No. Ajou University Hospital's IRB(Institutional Review Board) sends IRB approval documents to HIRA and conducts research with anonymized data after request. Data collected during the research process will be stored for 3 years and then properly disposed of in accordance with relevant laws.
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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.
DukYong Yoon, MD., PhD. principal investigator
Department of Biomedical Systems Informatics,Yonsei University College of Medicine,Yongin,SouthKorea
Seong-Joon Lee, MD., PhD. principal investigator
Department of Neurology, Ajou University School of Medicine, Suwon, South Korea
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Infarction and Infarction, Brain, run by Ajou University School of Medicine.
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 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SooJung Kim (82-31-219-6773, 438104@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year survival rate (time frame: Check the data one year after the onset of stroke.). The study lists 11 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 NCT05817097, which also lists 7 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 20 Jul 2023.