Association of Angiotensin-Converting Enzyme Inhibitors a... | NCT07262710

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

NCT07262710

Sponsor

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Status

Not yet recruiting

Last Update Posted

Dec 4, 2025Actual

Enrollment

13,656Estimated

Phase

Not provided

Conditions

Post-stroke Pneumonia

Interventions

angiotensin converting enzyme inhibitors
Calcium Channel Blockers
Angiotensin Receptor Blockers

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2025Estimated

Primary Completion Date

Aug 1, 2026Estimated

Completion Date

Aug 19, 2026Estimated

First Submitted Date

Nov 23, 2025

First Submission Date that Met QC Criteria

Nov 23, 2025

First Posted Date

Dec 4, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 23, 2025

Last Update Posted Date

Dec 4, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

13,656Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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).

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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

Sampling Method

Probability Sample

ID	Term
D000806	Angiotensin-Converting Enzyme Inhibitors
D002121	Calcium Channel Blockers
D057911	Angiotensin Receptor Antagonists

ID	Term
D011480	Protease Inhibitors
D004791	Enzyme Inhibitors
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D049990	Membrane Transport Modulators
D000077264	Calcium-Regulating Hormones and Agents
D045505	Physiological Effects of Drugs
D002317	Cardiovascular Agents
D045506	Therapeutic Uses