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

NCT ID: NCT07262710

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

13656 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-08-19

Brief Summary

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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.

Detailed Description

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Conditions

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Post-stroke Pneumonia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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ACEI-exposed group

Newly Initiated ACEI

angiotensin converting enzyme inhibitors

Intervention Type 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.

ARB-exposed group

Newly Initiated ARB

Angiotensin Receptor Blockers

Intervention Type DRUG

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

Calcium Channel Blockers

Intervention Type 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 group2

Newly Initiated CCB

Calcium Channel Blockers

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Xiaonong Fan

Chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Xiaonong Fan

Role: CONTACT

+86 139 0208 0823

Other Identifiers

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XFan

Identifier Type: -

Identifier Source: org_study_id

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