Coronary Artery DiseasePhase 4EItoCVPNCT06338293
Effects of Inclisiran Combined With Statins on the Morphology of Coronary Vulnerable Plaques
A Phase 4 study testing Inclisiran sodium and Rosuvastatin in people with Coronary Artery Disease, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
Effects of inclisiran + statins vs. statins on the morphology and vascular function of coronary vulnerable plaques, in order to provide a better treatment and more detailed imaging basis for the treatment of coronary vulnerable plaques. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Inclisiran sodium and Rosuvastatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2024to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion criteria: 1. Age 18-80 years old; 2. Coronary angiography (CAG) showed that the diameter of the primary coronary lesion was 20 ~ 70%, and the lesion was confirmed by OCT and OFR analysis, in which the target lesion contained at least one vulnerable plaque (the thinnest fibrous cap thickness was ≤65um, and the lipid core was ≥ 90), and the target vessel did not need further percutaneous coronary intervention (PCI); 3. Patients have been treated with statins for ≥4 weeks, but their LDL-C level were still ≥ 70 mg/dl (≥ 1.8 mmol/l).
Exclusion criteria: 1. Acute myocardial infarction occurred in recent 30 days; 2. The target lesion of coronary artery is severely distorted and angulated; Severe left main artery lesion, chronic occlusive lesion and bifurcation lesion; 3. Previous CABG; 4. Serum triglyceride (TG) > 500 mg/dl (> 5.6 mmol/l); 5. Patients with severe heart failure (< 40%) and respiratory failure; 6. Severe renal insufficiency (eGFR < 30ml ／min／1.73m2), active liver disease or severe liver damage;7. allergic to statins or inclisiran, and used PCSK9 monoclonal antibody in the past; 8. Known active infection or severe blood, metabolic or endocrine dysfunction; 9. Non-cardiac surgery is planned within 12 months; 10, can't follow the requirements of the follow-up, or researchers believe that the subjects to participate in the trial will increase the risk.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
NanJing Frist Hospital
Nanjing, Jiangsu, 210006
Meng Pei Na, Doctor, 86+15805199492, 527114121@qq.com
Meng Pei Na, Doctor
About this study
Official title: Using OFR Software to Observe the Effects of Inclisiran Combined With Statins on the Morphology and Vascular Function of Coronary Vulnerable Plaques
Effects of inclisiran + statins vs. statins on the morphology and vascular function of coronary vulnerable plaques, in order to provide a better treatment and more detailed imaging basis for the treatment of coronary vulnerable plaques.
Read the detailed description
The identification and treatment of vulnerable coronary plaques is still the focus of coronary heart disease research in recent several years. There are many methods to identify vulnerable plaque, such as NIRS, IVUS, OCT, but these methods have their own advantages and disadvantages, and they can't give the characteristics of diseased plaque completely and clearly. Therefore, if you want to better identify, track and treat vulnerable plaques, you need the comprehensive judgment of multi-modal detection methods, such as the comprehensive data of NIRS, IVUS, OCT, but in this case, there will be more and more invasive operations for patients, and the operation cost is high and time-consuming. OFR analysis software can quickly analyze the morphological and functional parameters of diseased vascular plaques based on OCT data, overcome the shortcomings of poor penetration of OCT and inability to observe the overall lesion contour, and can immediately give the morphological and functional parameters of diseased plaques, combining the data results of OCT, IVUS and FFR multimodal detection methods.
Statins have the effect of inducing regression and transforming coronary plaques into stability, but there are also some problems in the process of statin treatment. For example, for some patients with coronary heart disease, even the maximum tolerated dose of statins can not achieve the target goal of LDL-Cl; The side effects of statins, such as liver damage, muscle pain and blood sugar fluctuation, reduce the compliance of some patients. In recent years, the lipid-lowering effect of non-statins and the effect of stabilizing and reversing plaques have also attracted much attention, especially PCSK9 monoclonal antibody, such as, GLAGOV study, HUYGENS study, ALTAIR study and PACMAN-AMI study, compared with statins, they can reduce the plaques volume and stabilize the plaques morphology.
Inclisiran is the first siRNA drug in cardiovascular field. As a new generation of drugs acting on PCSK9, the current clinical research (ORION research series 1, 3, 8, 9, 10, 11) shows good lipid-lowering efficacy and safety tolerance. On the basis of statin therapy, LDL-C46%-55% is further reduced, which is more durable than monoclonal antibody, and the drug effect can last for half a year once used, and it has good safety and tolerance (except for the slight reaction of injection, there are almost no other side effects). So far, the research of Inclisiran mainly focuses on the safety and efficacy of lipid-lowering and the observation of clinical events, and the research on vulnerable plaque is very scarce. In this study, OFR analysis software will be used to observe whether Inclisiran combined with statin is superior to statin standard treatment on the vulnerable plaques, and it is expected to provide more superior clinical treatment scheme and more accurate imaging basis for identifying and treating vulnerable coronary plaques.
- Conditions
- Coronary Artery Disease
- Being tested
- Inclisiran sodium, Rosuvastatin
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inclisiran sodiumDrug
The patients in Inclisiran group were given drugs three times in total. The first needle was injected subcutaneously with 284mg(1.5ml solution) after entering the group, the second needle was injected three months later and the third needle was injected at the ninth month.
RosuvastatinDrug
Rosuvastatin
| Study group | Role | What they receive |
|---|---|---|
| Inclisiran＋rosuvastatin group | Experimental | Inclisiran sodium＋rosuvastatin 20mg group: Rosuvastatin was given 20mg daily for one year, and Inclisiran was given three times in total. After the first injection, 284mg(1.5ml solution) was injected subcutaneously, the second injection was 3 months after the first injection, and the third injection was in the ninth month. Receives: Drug: Inclisiran sodium; Drug: Rosuvastatin |
| Rosuvastatin group | Placebo comparator | Rosuvastatin group: Rosuvastatin 20mg daily for one year. Receives: Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change rate of the thinnest fibrous cap of vulnerable plaque at the target vascular lesion from baseline to one-year follow-up(△ FCT%)
The change rate of the thinnest fibrous cap of vulnerable plaque at the target vascular lesion from baseline to one-year follow-up(△ FCT%)
Measured: one-year
Secondary outcomes (5)
The change rate of TAV and plaque load of the target vascular lesion;
The change rate of TAV and plaque load of the target vascular lesion from baseline to one-year follow-up;
Measured: one-year
The change rate of lipid composition of plaque: including the lipid volume , the maximum area and angle of lipid, the length of vulnerable plaque, etc.
The change rate of lipid composition of plaque: including the lipid volume from baseline to one-year follow-up , the maximum area and angle of lipid from baseline to one-year follow-up, the length of vulnerable plaque from baseline to one-year follow-up, etc.
Measured: one-year
The change rates of other components of plaque (fiber, calcification, crystal, macrophage)
The change rates of other components of plaque from baseline to one-year follow-up (fiber, calcification, crystal, macrophage)
Measured: one-year
The change rates of lesion OFR and target vessel OFR
The change rates of lesion OFR and target vessel OFR from baseline to one-year follow-up
Measured: one-year
The change rates of other indexes (low density lipoprotein level, Lp-PLA2, hs-CRP, etc.)
The change rates of other indexes from baseline to one-year follow-up(low density lipoprotein level, Lp-PLA2, hs-CRP, etc.)
Measured: one-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start15 Mar 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- China Jiangsu, Principal investigator, Nanjin First Hospital,Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338293
- Sponsor's protocol ID
- KY20240123-02
- Acronym
- EItoCVP
- Status last verified
- Feb 2025
- First submitted
- 26 Feb 2024
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using OFR Software to Observe the Effects of Inclisiran Combined With Statins on the Morphology and Vascular Function of Coronary Vulnerable Plaques
- ClinicalTrials.gov ID
- NCT06338293
- Acronym / sponsor ID
- EItoCVP / KY20240123-02
- Conditions
- Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Mar 2024 (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.
Effects of inclisiran + statins vs. statins on the morphology and vascular function of coronary vulnerable plaques, in order to provide a better treatment and more detailed imaging basis for the treatment of coronary vulnerable plaques.
Detailed description
The identification and treatment of vulnerable coronary plaques is still the focus of coronary heart disease research in recent several years. There are many methods to identify vulnerable plaque, such as NIRS, IVUS, OCT, but these methods have their own advantages and disadvantages, and they can't give the characteristics of diseased plaque completely and clearly. Therefore, if you want to better identify, track and treat vulnerable plaques, you need the comprehensive judgment of multi-modal detection methods, such as the comprehensive data of NIRS, IVUS, OCT, but in this case, there will be more and more invasive operations for patients, and the operation cost is high and time-consuming. OFR analysis software can quickly analyze the morphological and functional parameters of diseased vascular plaques based on OCT data, overcome the shortcomings of poor penetration of OCT and inability to observe the overall lesion contour, and can immediately give the morphological and functional parameters of diseased plaques, combining the data results of OCT, IVUS and FFR multimodal detection methods.
Statins have the effect of inducing regression and transforming coronary plaques into stability, but there are also some problems in the process of statin treatment. For example, for some patients with coronary heart disease, even the maximum tolerated dose of statins can not achieve the target goal of LDL-Cl; The side effects of statins, such as liver damage, muscle pain and blood sugar fluctuation, reduce the compliance of some patients. In recent years, the lipid-lowering effect of non-statins and the effect of stabilizing and reversing plaques have also attracted much attention, especially PCSK9 monoclonal antibody, such as, GLAGOV study, HUYGENS study, ALTAIR study and PACMAN-AMI study, compared with statins, they can reduce the plaques volume and stabilize the plaques morphology.
Inclisiran is the first siRNA drug in cardiovascular field. As a new generation of drugs acting on PCSK9, the current clinical research (ORION research series 1, 3, 8, 9, 10, 11) shows good lipid-lowering efficacy and safety tolerance. On the basis of statin therapy, LDL-C46%-55% is further reduced, which is more durable than monoclonal antibody, and the drug effect can last for half a year once used, and it has good safety and tolerance (except for the slight reaction of injection, there are almost no other side effects). So far, the research of Inclisiran mainly focuses on the safety and efficacy of lipid-lowering and the observation of clinical events, and the research on vulnerable plaque is very scarce. In this study, OFR analysis software will be used to observe whether Inclisiran combined with statin is superior to statin standard treatment on the vulnerable plaques, and it is expected to provide more superior clinical treatment scheme and more accurate imaging basis for identifying and treating vulnerable coronary plaques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inclisiran＋rosuvastatin group | Experimental | Drug: Inclisiran sodium, Drug: RosuvastatinInclisiran sodium＋rosuvastatin 20mg group: Rosuvastatin was given 20mg daily for one year, and Inclisiran was given three times in total. After the first injection, 284mg(1.5ml solution) was injected subcutaneously, the second injection was 3 months after the first injection, and the third injection was in the ninth month. |
| Rosuvastatin group | Placebo comparator | Drug: RosuvastatinRosuvastatin group: Rosuvastatin 20mg daily for one year. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Inclisiran sodiumThe patients in Inclisiran group were given drugs three times in total. The first needle was injected subcutaneously with 284mg(1.5ml solution) after entering the group, the second needle was injected three months later and the third needle was injected at the ninth month. | Drug | Inclisiran＋rosuvastatin group |
| RosuvastatinRosuvastatin | Drug | Inclisiran＋rosuvastatin group, Rosuvastatin group |
Primary outcome
The change rate of the thinnest fibrous cap of vulnerable plaque at the target vascular lesion from baseline to one-year follow-up(△ FCT%)
Time frame: one-year
The change rate of the thinnest fibrous cap of vulnerable plaque at the target vascular lesion from baseline to one-year follow-up(△ FCT%)
5 secondary outcomes
The change rate of TAV and plaque load of the target vascular lesion;
Time frame: one-year
The change rate of lipid composition of plaque: including the lipid volume , the maximum area and angle of lipid, the length of vulnerable plaque, etc.
Time frame: one-year
The change rates of other components of plaque (fiber, calcification, crystal, macrophage)
Time frame: one-year
The change rates of lesion OFR and target vessel OFR
Time frame: one-year
The change rates of other indexes (low density lipoprotein level, Lp-PLA2, hs-CRP, etc.)
Time frame: one-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 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.
China Jiangsu principal investigator
Nanjin First Hospital,Nanjing Medical University
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 Inclisiran sodium and Rosuvastatin in people with Coronary Artery Disease, run by Nanjing First Hospital, Nanjing Medical University 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?
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: looking for participants now, as of the sponsor's last update on 14 Feb 2025. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peina Meng, MD (8615805199492, 527114121@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change rate of the thinnest fibrous cap of vulnerable plaque at the target vascular lesion from baseline to one-year follow-up(△ FCT%) (time frame: one-year). 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 14 Feb 2025.