Atherosclerotic Cardiovascular Disease (ASCVD)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
An observational study of Atherosclerotic Cardiovascular Disease (ASCVD) and Benign Prostatic Hypertrophy (BPH), run by Chinese PLA General Hospital.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease (ASCVD), Benign Prostatic Hypertrophy (BPH)
- What is being tested?
- 5-Alpha Reductase Inhibitors
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 31 Dec 2022
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The study population was derived from the UK Biobank (UKB). Detailed descriptions of the UKB have been published previously.
Who may be able to join
- patients diagnosed with BPH or users of 5-ARIs
Who cannot join
- individuals who had cancer prior to the start of follow-up and those with pre-existing ASCVD
About this study
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).
- Being tested
- 5-Alpha Reductase Inhibitors
- Medical subject headings
- Atherosclerosis, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-Alpha Reductase InhibitorsDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Atherosclerotic Cardiovascular Disease
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)
Measured: Started taking 5α-reductase inhibitors until December 1, 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start1 Jan 2012
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular Disease (ASCVD)Studies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing Yuan, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196280
- Sponsor's protocol ID
- S2022-700-02
- Status last verified
- Sep 2025
- First submitted
- 3 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07196280
- Acronym / sponsor ID
- S2022-700-02
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population was derived from the UK Biobank (UKB). Detailed descriptions of the UKB have been published previously.
Key inclusion criteria (1 listed)
- patients diagnosed with BPH or users of 5-ARIs
Key exclusion criteria (1 listed)
- individuals who had cancer prior to the start of follow-up and those with pre-existing ASCVD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-Alpha Reductase InhibitorsBuilding 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. | Drug | – |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerotic Cardiovascular Disease (ASCVD) and Benign Prostatic Hypertrophy (BPH), run by Chinese PLA General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atherosclerotic Cardiovascular Disease (time frame: Started taking 5α-reductase inhibitors until December 1, 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.