Association of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With Post-Stroke Pneumonia: A Real-World Retrospective Cohort Study

November 23, 2025 updated by: Xiaonong Fan, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13656

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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

Description

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Aage ≥18 years.

Exclusion Criteria:

  1. Data anomalies or errors(such as an inaccurately recorded date of death).
  2. Concurrent use of two or three drug classes among ACEI, ARB, and CCB at any time.
  3. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACEI-exposed group
Newly Initiated ACEI
Drug: angiotensin converting enzyme inhibitors
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.
ARB-exposed group
Newly Initiated ARB
Drug: Angiotensin Receptor Blockers
The Angiotensin Receptor Blockers (ARBs) included in this analysis were Losartan, Eprosartan, Valsartan, Irbesartan, Candesartan, Telmisartan, Olmesartan Medoxomil, Azilsartan Medoxomil, and Fimasartan.
CCB-exposed group1
Newly Initiated CCB
Drug: Calcium Channel Blockers
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.
CCB-exposed group2
Newly Initiated CCB
Drug: Calcium Channel Blockers
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 19, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XFan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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