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Completed

NCT Number: NCT07196280

Protective Effect of 5-Alpha Reductase Inhibitors on Atherosclerotic Cardiovascular Disease in Populations With BPH: Evidence From UK Biobank Cohort and Chinese Single Center Database Studies

To assess the impact of 5-alpha reductase inhibitors (5-ARIs) on the incidence of atherosclerotic cardiovascular disease (ASCVD) in patients with benign prostatic hyperplasia (BPH).

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients diagnosed with BPH or users of 5-ARIs

Exclusion criteria

  • individuals who had cancer prior to the start of follow-up and those with pre-existing ASCVD

Treatment and study plan

5-Alpha Reductase Inhibitors

Drug

Building on prior studies, drug exposure was defined as receiving 5-ARIs on at least two separate occasions, with an interval of no more than 180 days between prescriptions. Based on exposure status, the cohort was stratified into two groups.

Primary outcomes

  1. Atherosclerotic Cardiovascular Disease

    Time frame: Started taking 5α-reductase inhibitors until December 1, 2022

    While both CVD and ASCVD are composite disease categories, CVD encompasses a broader range of cardiovascular and cerebrovascular conditions. To ensure homogeneity in disease classification, we focused on ASCVD, which primarily refers to atherosclerosis-related cardiovascular and cerebrovascular diseases, including ischemic heart disease (IHD) and cerebrovascular disease (CeVD)

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2022
Study completion
2022
First posted
Sep 29, 2025
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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