Post-stroke PneumoniaNCT07262710
Association of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With Post-Stroke Pneumonia: A Real-World Retrospective Cohort Study
An observational study of Post-stroke Pneumonia, run by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine.
Trial summary
The goal of this retrospective cohort study is to determine if Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin Receptor Blockers (ARBs) can lower the risk of post-stroke pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-stroke Pneumonia
- What is being tested?
- angiotensin converting enzyme inhibitors, Calcium Channel Blockers and Angiotensin Receptor Blockers
- How many people
- 13,656 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 19 Aug 2026
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diagnosis of both stroke and hypertension, with the initial diagnosis dates for both conditions falling within the period from January 1, 2016, to December 31, 2024
Who may be able to join
- Diagnosis of both stroke and hypertension, with the initial diagnosis dates for both conditions falling within the period from January 1, 2016, to December 31, 2024.Definition of Stroke: International Classification of Diseases, 10th Revision (ICD-10) codes I60-I64, or a primary diagnosis of stroke-related conditions in inpatient/outpatient medical records, including but not limited to: cerebral hemorrhage, hemorrhagic stroke, cerebral infarction, ischemic stroke, cerebral ischemia, brainstem infarction.Definition of Hypertension: ICD-10 code I10, or inpatient/outpatient medical records containing diagnostic names such as hypertension, benign hypertension, hypertensive crisis.
- At least one prescription filled from any of the five major classes of antihypertensive medications: Angiotensin-Converting Enzyme Inhibitors (ACEI), Angiotensin II Receptor Blockers (ARB), Beta-blockers, Calcium Channel Blockers (CCB), or Diuretics. Furthermore, there must be no record of any ACEI, ARB, or CCB prescriptions within the 12 months immediately preceding the first ACEI, ARB, or CCB prescription.
- Aage ≥18 years.
Who cannot join
- Data anomalies or errors(such as an inaccurately recorded date of death).
- Concurrent use of two or three drug classes among ACEI, ARB, and CCB at any time.
- Any recorded diagnosis of pneumonia prior to the initiation of the first antihypertensive medication.Definition of Pneumonia: ICD-10 codes J12-J18 or J69, or inpatient/outpatient medical records containing diagnostic names such as pulmonary infection, pneumonia, lung infection.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this retrospective cohort study is to determine if Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin Receptor Blockers (ARBs) can lower the risk of post-stroke pneumonia. With an active comparator, new-user design, we selected new users of Calcium Channel Blockers (CCBs) as the reference group to compare against new users of ACEIs/ARBs.
- Conditions
- Post-stroke Pneumonia
- Being tested
- angiotensin converting enzyme inhibitors, Calcium Channel Blockers, Angiotensin Receptor Blockers
- Keywords
- post-stroke pneumonia, angiotensin converting enzyme inhibitors, angiotensin receptor blockers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
angiotensin converting enzyme inhibitorsDrug
The Angiotensin-Converting Enzyme Inhibitors (ACEIs) in this study included Captopril, Enalapril, Lisinopril, Perindopril, Ramipril, Quinapril, Benazepril, Cilazapril, Fosinopril, Trandolapril, Spirapril, Delapril, Moexipril, Temocapril, Zofenopril, and Imidapril.
Calcium Channel BlockersDrug
The Calcium Channel Blockers (CCBs) evaluated as the active comparator in this study comprised a comprehensive list, including Amlodipine, Felodipine, Isradipine, Nicardipine, Nifedipine, Nimodipine, Nitrendipine, Lacidipine, Nilvadipine, Manidipine, Barnidipine, Lercanidipine, Cilnidipine, Benidipine, Clevidipine, Mibefradil, Verapamil, Gallopamil, Diltiazem, Fendiline, and Bepridil.
Angiotensin Receptor BlockersDrug
The Angiotensin Receptor Blockers (ARBs) included in this analysis were Losartan, Eprosartan, Valsartan, Irbesartan, Candesartan, Telmisartan, Olmesartan Medoxomil, Azilsartan Medoxomil, and Fimasartan.
| Study group | Role | What they receive |
|---|---|---|
| ACEI-exposed group | Newly Initiated ACEI Receives: Drug: angiotensin converting enzyme inhibitors | |
| ARB-exposed group | Newly Initiated ARB Receives: Drug: Angiotensin Receptor Blockers | |
| CCB-exposed group1 | Newly Initiated CCB Receives: Drug: Calcium Channel Blockers | |
| CCB-exposed group2 | Newly Initiated CCB Receives: Drug: Calcium Channel Blockers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of post-stroke pneumonia
Measured: The follow-up end point was defined as the earliest occurrence of any of the following events: a diagnosis of pneumonia, death, the date of the last available medical record in the database, or the end of the study period (December 31, 2024).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion19 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-stroke PneumoniaStudies 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
- 13,656 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaonong Fan, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262710
- Sponsor's protocol ID
- XFan
- Status last verified
- Oct 2025
- First submitted
- 23 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With Post-Stroke Pneumonia: A Real-World Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07262710
- Acronym / sponsor ID
- XFan
- Conditions
- Post-stroke Pneumonia
- Keywords
- post-stroke pneumonia, angiotensin converting enzyme inhibitors, angiotensin receptor blockers
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 13,656 participants (estimated)
- Lead sponsor
- First Teaching Hospital of Tianjin University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 19 Aug 2026 (estimated)
- First posted
- 4 Dec 2025 (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 retrospective cohort study is to determine if Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin Receptor Blockers (ARBs) can lower the risk of post-stroke pneumonia. With an active comparator, new-user design, we selected new users of Calcium Channel Blockers (CCBs) as the reference group to compare against new users of ACEIs/ARBs.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ACEI-exposed group | – | Drug: angiotensin converting enzyme inhibitorsNewly Initiated ACEI |
| ARB-exposed group | – | Drug: Angiotensin Receptor BlockersNewly Initiated ARB |
| CCB-exposed group1 | – | Drug: Calcium Channel BlockersNewly Initiated CCB |
| CCB-exposed group2 | – | Drug: Calcium Channel BlockersNewly Initiated CCB |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosis of both stroke and hypertension, with the initial diagnosis dates for both conditions falling within the period from January 1, 2016, to December 31, 2024
Key inclusion criteria (3 listed)
- Diagnosis of both stroke and hypertension, with the initial diagnosis dates for both conditions falling within the period from January 1, 2016, to December 31, 2024.Definition of Stroke: International Classification of Diseases, 10th Revision (ICD-10) codes I60-I64, or a primary diagnosis of stroke-related conditions in inpatient/outpatient medical records, including but not limited to: cerebral hemorrhage, hemorrhagic stroke, cerebral infarction, ischemic stroke, cerebral ischemia, brainstem infarction.Definition of Hypertension: ICD-10 code I10, or inpatient/outpatient medical records containing diagnostic names such as hypertension, benign hypertension, hypertensive crisis.
- At least one prescription filled from any of the five major classes of antihypertensive medications: Angiotensin-Converting Enzyme Inhibitors (ACEI), Angiotensin II Receptor Blockers (ARB), Beta-blockers, Calcium Channel Blockers (CCB), or Diuretics. Furthermore, there must be no record of any ACEI, ARB, or CCB prescriptions within the 12 months immediately preceding the first ACEI, ARB, or CCB prescription.
- Aage ≥18 years.
Key exclusion criteria (3 listed)
- Data anomalies or errors(such as an inaccurately recorded date of death).
- Concurrent use of two or three drug classes among ACEI, ARB, and CCB at any time.
- Any recorded diagnosis of pneumonia prior to the initiation of the first antihypertensive medication.Definition of Pneumonia: ICD-10 codes J12-J18 or J69, or inpatient/outpatient medical records containing diagnostic names such as pulmonary infection, pneumonia, lung infection.
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 converting enzyme inhibitorsThe Angiotensin-Converting Enzyme Inhibitors (ACEIs) in this study included Captopril, Enalapril, Lisinopril, Perindopril, Ramipril, Quinapril, Benazepril, Cilazapril, Fosinopril, Trandolapril, Spirapril, Delapril, Moexipril, Temocapril, Zofenopril, and Imidapril. | Drug | ACEI-exposed group |
| Calcium Channel BlockersThe Calcium Channel Blockers (CCBs) evaluated as the active comparator in this study comprised a comprehensive list, including Amlodipine, Felodipine, Isradipine, Nicardipine, Nifedipine, Nimodipine, Nitrendipine, Lacidipine, Nilvadipine, Manidipine, Barnidipine, Lercanidipine, Cilnidipine, Benidipine, Clevidipine, Mibefradil, Verapamil, Gallopamil, Diltiazem, Fendiline, and Bepridil. | Drug | CCB-exposed group1, CCB-exposed group2 |
| Angiotensin Receptor BlockersThe Angiotensin Receptor Blockers (ARBs) included in this analysis were Losartan, Eprosartan, Valsartan, Irbesartan, Candesartan, Telmisartan, Olmesartan Medoxomil, Azilsartan Medoxomil, and Fimasartan. | Drug | ARB-exposed group |
Primary outcome
Occurrence of post-stroke pneumonia
Time frame: The follow-up end point was defined as the earliest occurrence of any of the following events: a diagnosis of pneumonia, death, the date of the last available medical record in the database, or the end of the study period (December 31, 2024).
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 4 Dec 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-stroke Pneumonia, run by First Teaching Hospital of Tianjin University of Traditional Chinese 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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 4 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaonong Fan (+86 139 0208 0823, fanxiaonong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of post-stroke pneumonia (time frame: The follow-up end point was defined as the earliest occurrence of any of the following events: a diagnosis of pneumonia, death, the date of the last available medical record in the database, or the end of the study period (December 31, 2024).). 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 Dec 2025.