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

NCT07262710 | Not Yet Recruiting DMC

• 1 other identifier: XFan
• Study Type: observational
• Target: 13,656
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Keywords

post-stroke pneumonia; angiotensin converting enzyme inhibitors; angiotensin receptor blockers

Outcome Measures

Primary Outcomes (1)

• Occurrence of post-stroke pneumonia

  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).

Study Arms (4)

ACEI-exposed group

Newly Initiated ACEI

Drug: angiotensin converting enzyme inhibitors

ARB-exposed group

Newly Initiated ARB

Drug: Angiotensin Receptor Blockers

CCB-exposed group1

Newly Initiated CCB

Drug: Calcium Channel Blockers

CCB-exposed group2

Newly Initiated CCB

Drug: Calcium Channel Blockers

Interventions

angiotensin converting enzyme inhibitors DRUG

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.

ACEI-exposed group

Calcium Channel Blockers DRUG

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 group1; CCB-exposed group2

Angiotensin Receptor Blockers DRUG

The Angiotensin Receptor Blockers (ARBs) included in this analysis were Losartan, Eprosartan, Valsartan, Irbesartan, Candesartan, Telmisartan, Olmesartan Medoxomil, Azilsartan Medoxomil, and Fimasartan.

ARB-exposed group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Teaching Hospital of Tianjin University of Traditional Chinese Medicine: lead

MeSH Terms

Interventions

Angiotensin-Converting Enzyme Inhibitors; Calcium Channel Blockers; Angiotensin Receptor Antagonists

Intervention Hierarchy (Ancestors)

Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Cardiovascular Agents; Therapeutic Uses

Central Study Contacts

Xiaonong Fan

CONTACT

+86 139 0208 0823; fanxiaonong@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: December 4, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 19, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-10