Adverse Effect of Cardiovascular Medications (Diagnosis)Phase 4NCT05802108
Effect of PCSK9 Inhibitor on Retinal Microvessels in Patients With Coronary Heart Disease After Intensive Lipid-lowering Therapy
A Phase 4 study testing Evolocumab combined with statins and Statin in people with Adverse Effect of Cardiovascular Medications (Diagnosis), run by Zibo Central Hospital at 1 site in China.
Trial summary
In patients with coronary heart disease who were treated with PCSK9 inhibitor evolocumab for intensive lipid-lowering therapy, the changes of retinal microvessels were measured with OCTA (Optical Coherence Tomography Angiography)before and after the treatment. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Adverse Effect of Cardiovascular Medications (Diagnosis)
- What is being tested?
- Evolocumab combined with statins and Statin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 30 Jun 2024
- Phase
- Phase 4
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50-75 years old, gender unlimited;
- Diagnosed as coronary atherosclerotic heart disease
- The informed consent for the study has been signed
Who cannot join
- Those who are unable to cooperate with the examination;
- Poor imaging quality of refractive interstitial opacity;
- Macular edema or complicated with macular membrane and senile macular degeneration;
- Have a history of previous fundus surgery;
- Those with eye diseases that can cause changes in the microvessels of the fundus;
- Abnormal elevated intraocular pressure;
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- Moderate or above refractive error (≥ ± 3 diopters)
- People with cognitive impairment, material dependence, and serious mental illness;
- Those who do not cooperate with follow-up;
- Those who participate in other clinical trials at the same time
Trial locations and contacts
1 site in 1 country.
Lifen Gao, Master contact
China1 site, 1 recruiting
- Recruiting
Zibo Central Hospital
Zibo, Shandong, 255000
Xinyu Wang, Master, 13181933930, wxysd2021@163.com
About this study
In patients with coronary heart disease who were treated with PCSK9 inhibitor evolocumab for intensive lipid-lowering therapy, the changes of retinal microvessels were measured with OCTA (Optical Coherence Tomography Angiography)before and after the treatment. The specific indicators included retinal microvessel diameter, macular area，optic disc vascular density and FAZ(Foveal Avascular Zone)area, etc., to clarify the effect of evolocumab on retinal microvessels after intensive lipid-lowering therapy.
- Being tested
- Evolocumab combined with statins, Statin
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evolocumab combined with statinsDrug
Also called drug1
The experimental group was treated with evolocumab combined with statin for lipid-lowering
StatinDrug
Also called drug2
the control group was treated with statin only for lipid-lowering
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | evolocumab combined with statins Receives: Drug: Evolocumab combined with statins |
| Control Group | Other | statins only Receives: Drug: Statin |
What is being measured
The primary outcome is the main question the study is designed to answer.
the main indicator
Video disc area (4.5 × 4.5 mm2) of the radial capillary network (RPC) around the nipple and the macular area (6 × 6 mm2), superficial retinal vascular plexus (SCP) and deep retinal vascular plexus (DCP).
Measured: Up to 12 months
Secondary outcomes (1)
the secondary indicator
The thickness of the retinal nerve fiber layer (RNFL) near the optic disc, the thickness of the retinal ganglion cell layer in the macular region, the area of the avascular zone (FAZ) in the fovea, the changes of blood lipids, and the changes of the diameter of the retinal branch veins near the optic disc
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start1 Jul 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Effect of Cardiovascular Medications (Diagnosis)Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zibo Central Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bo Li, Zibo Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802108
- Sponsor's protocol ID
- ZiboCH2
- Status last verified
- Mar 2023
- First submitted
- 11 Mar 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of PCSK9 Inhibitor on Retinal Microvessels in Patients With Coronary Heart Disease After Intensive Lipid-lowering Therapy
- ClinicalTrials.gov ID
- NCT05802108
- Acronym / sponsor ID
- ZiboCH2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zibo Central HospitalOther government
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 6 Apr 2023 (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.
In patients with coronary heart disease who were treated with PCSK9 inhibitor evolocumab for intensive lipid-lowering therapy, the changes of retinal microvessels were measured with OCTA (Optical Coherence Tomography Angiography)before and after the treatment. The specific indicators included retinal microvessel diameter, macular area，optic disc vascular density and FAZ(Foveal Avascular Zone)area, etc., to clarify the effect of evolocumab on retinal microvessels after intensive lipid-lowering therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: Evolocumab combined with statinsevolocumab combined with statins |
| Control Group | Other | Drug: Statinstatins only |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 50-75 years old, gender unlimited;
- Diagnosed as coronary atherosclerotic heart disease
- The informed consent for the study has been signed
Key exclusion criteria (10 listed)
- Those who are unable to cooperate with the examination;
- Poor imaging quality of refractive interstitial opacity;
- Macular edema or complicated with macular membrane and senile macular degeneration;
- Have a history of previous fundus surgery;
- Those with eye diseases that can cause changes in the microvessels of the fundus;
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 |
|---|---|---|
| Evolocumab combined with statinsAlso: drug1The experimental group was treated with evolocumab combined with statin for lipid-lowering | Drug | Experimental Group |
| StatinAlso: drug2the control group was treated with statin only for lipid-lowering | Drug | Control Group |
Primary outcome
the main indicator
Time frame: Up to 12 months
Video disc area (4.5 × 4.5 mm2) of the radial capillary network (RPC) around the nipple and the macular area (6 × 6 mm2), superficial retinal vascular plexus (SCP) and deep retinal vascular plexus (DCP).
1 secondary outcome
the secondary indicator
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
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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.
Lifen Gao, Master contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Evolocumab combined with statins and Statin in people with Adverse Effect of Cardiovascular Medications (Diagnosis), run by Zibo Central Hospital at 1 site in China.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xinyu Wang, Master (13181933930, wxysd2021@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the main indicator (time frame: Up to 12 months). 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 6 Apr 2023.