Coronary Heart DiseasePhase 4V-INVINCIBLENCT06941792
Inclisiran Effectiveness in China: a Pragmatic Randomized Trial
A Phase 4 study testing inclisiran sodium injection in people with Coronary Heart Disease, run by Novartis Pharmaceuticals at 19 sites in China.
Trial summary
The current study will be conducted to evaluate the real-world effectiveness of inclisiran relative to standard of care (SoC) in Chinese patients with coronary heart disease (CHD), not only with the low-density lipoprotein cholesterol (LDL-C) change in 1 year, but also the LDL-C Test on Target for 1 year. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- inclisiran sodium injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,590 participants
- Where
- 19 sitesChina
- Study dates
- 17 Jun 2025to 30 Apr 2027
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent must be obtained prior to participation in the study
- Documented diagnosis of CHD prior to screening, including acute coronary syndrome (ACS) and chronic coronary syndrome (CCS)
- Aged ≥18 years at randomization
- Despite maximally tolerated statin therapy for ≥4weeks stable using prior to screening, LDL-C result at screening not at goal (≥1.8 mmol/L).
- The maximum tolerated dose of statins also includes patients with statin intolerance or contraindication.
Who cannot join
- Received inclisiran during the 2 years prior to the screening.
- Received proprotein convertase subtilisin-kexin type 9 (PCSK9) mabs during the 3 months prior to screening.
- Participating in an interventional trial at enrollment
- Having severe liver disorder (Child-Pugh class C)
- Any other condition that may put the participant at significant risk if the participant participate in the current study, according to investigator's (or delegate's) judgment.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
China19 sites
Novartis Investigative Site
Anqing, Anhui, 246003
Novartis Investigative Site
Baotou, Inner Mongolia, 014010
Novartis Investigative Site
Beijing, Beijing Municipality, 102218
Novartis Investigative Site
Chengdu, Sichuan, 610031
Novartis Investigative Site
Chongqing, Chongqing Municipality, 400010
Novartis Investigative Site
Hangzhou, Zhejiang, 310007
Novartis Investigative Site
Jiamusi, Heilongjiang, 154002
Novartis Investigative Site
Jinhua, Zhejiang, 321000
Novartis Investigative Site
Jining, Shandong, 272000
Novartis Investigative Site
Longyan, Fujian, 364099
Novartis Investigative Site
Ningbo, Zhejiang, 315000
Novartis Investigative Site
Shanghai, Shanghai Municipality, 200065
Novartis Investigative Site
Shenyang, Liaoning, 110016
Novartis Investigative Site
Shenyang, Liaoning, 121100
Novartis Investigated Site
Taiyuan, Shanxi, 030000
Novartis Investigative Site
Ürümqi, Xinjiang Uygur Autonomous Region, 830054
Novartis Investigative Site
Weifang, Shandong, 261000
Novartis Investigative Site
Wenzhou, Zhejiang, 325000
Novartis Investigative Site
Zhengzhou, Henan, 451400
About this study
Official title: Effectiveness of Inclisiran for Patients With Coronary Heart Disease in China: a Multicenter, Standard of Care-Controlled Pragmatic Randomized Trial
The current study will be conducted to evaluate the real-world effectiveness of inclisiran relative to standard of care (SoC) in Chinese patients with coronary heart disease (CHD), not only with the low-density lipoprotein cholesterol (LDL-C) change in 1 year, but also the LDL-C Test on Target for 1 year. This study further aims to assess the adherence, treatment patterns and satisfaction, and safety of inclisiran among Chinese patients.
Read the detailed description
The study is a multicenter, randomized, parallel, open-label, pragmatic trial, to assess the effectiveness of inclisiran in the real-world compared to SoC, in patients with CHD in China who did not achieve LDL-C goal despite maximally tolerated statin therapy for ≥4weeks stable using. CHD patients include patients with acute coronary syndrome and patients with chronic coronary syndrome.
After granting informed consent, being screened, and confirmed eligible for the study, participants will be randomized to 2 arms (inclisiran or SoC) in a 1:1 ratio.
Following the randomization, participants start inclisiran or SoC adaptation (which means switching to or adding on another/other lipid-lowering therapies (LLT[s]). This start date is defined as Day 0.
During follow-up, each participant will follow routine care, and the results of LDL-C tests will be collected for each Visit (every 3 months), with an allowable window of ±1.5 months. Each patient will be followed up until his/her end of study (EOS), which is the earliest of the end of follow-up period (Visit 4: approximately 12 months following Day 0), lost to follow-up, consent withdrawal, death, and participating in another interventional trial.
- Conditions
- Coronary Heart Disease
- Being tested
- inclisiran sodium injection, Standard of Care
- Keywords
- Inclisiran, effectiveness, lipid-lowering, low-density lipoprotein cholesterol Test on Target
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inclisiran sodium injectionDrug
After randomization, patients in the inclisiran group will receive inclisiran sodium injection
Standard of CareCombination product
After randomization switching to or adding on another/other lipid-lowering therapies
| Study group | Role | What they receive |
|---|---|---|
| inclisiran group | Experimental | patients in the inclisiran group will receive inclisiran (may or may not plus cholesterol absorption inhibitor at the discretion of the treating physician). Receives: Drug: inclisiran sodium injection |
| Standard of Care group | Active comparator | Patients in the SoC group will switch to/add on another/other LLT(s) at the discretion of the treating physician, as long as it is not inclisiran or an investigational drug. Receives: Combination Product: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage change in low-density lipoprotein cholesterol (LDL-C) level from baseline at 12 months, for the inclisiran group versus the standard of care (SoC) group
To evaluate the real-world effectiveness of inclisiran, on the change in LDL-C levels at Month 12, compared with SoC, in Chinese patients with coronary heart disease (CHD)
Measured: 12 months
Secondary outcomes (25)
The proportion of participants with the 1-year LDL-C Test on Target ≥75%, for the inclisiran group versus the SoC group
To evaluate the real-world effectiveness of inclisiran, on the LDL-C Test on Target at Month 12, compared with SoC, in Chinese patients with CHD
Measured: 12 months
The percentage change in LDL-C level from baseline at 3 months, 6 months, and 9 months, for the inclisiran group versus the SoC group
To evaluate the effectiveness of inclisiran on the change in LDL-C levels at Month 3, Month 6, and Month 9, compared with SoC
Measured: At Month 3, Month 6 and Month 9
The proportion of participants with LDL-C <1.8 mmol/L at 12 months, for the inclisiran group versus the SoC group
To evaluate the effectiveness of inclisiran on LDL-C at goal at Month 12
Measured: 12 months
To describe LDL-C Test on Target value during the 12 months after baseline, for the inclisiran group and the SoC group.
To evaluate the real-world effectiveness of inclisiran, on LDL-C Test on Target at 1 year, compared with the SoC group.
Measured: 12 months
The percentage change in levels of total cholesterol, triglyceride, HDL-C, Lp(a), ApoA, and ApoB, from baseline at 3 months, 6 months, 9 months, and 12 months, for the inclisiran group versus the SoC group
To evaluate the effectiveness of inclisiran on the change in other parameters of the lipid profile at Month 3, Month 6, Month 9, and Month 12, compared with SoC
Measured: At Month 3, Month 6, Month 9, and Month 12
Area under the curve (AUC) of LDL-C level versus time (from 0 months to 12 months), for the inclisiran group versus the SoC group
To evaluate the accumulated LDL-C in the inclisiran group and the SoC group
Measured: Baseline, 12 months
The proportion of participants with PDCinclisiran≥80% in the inclisiran group and the proportion of participants with PDCnon-statin≥80% in the SoC group, at 3 months, 6 months, 9 months, and 12 months
To estimate the adherence to inclisiran and other non-statin lipid-lowering therapies (LLTs), as measured by the proportion of days covered (PDC), using prescription data
Measured: At Month 3, Month 6, Month 9, and Month 12
The average number of days covered, of inclisiran in the inclisiran group and of non-statin lipid-lowering therapies (LLTs) in the SoC group, at 3 months, 6 months, 9 months, and 12 months
To estimate the adherence to inclisiran and other non-statin lipid-lowering therapies (LLTs), as measured by the proportion of days covered (PDC), using prescription data
Measured: At Month 3, Month 6, Month 9, and Month 12
The average PDCinclisiran in the inclisiran group and the average PDCnon-statin in the SoC group, at 3 months, 6 months, 9 months, and 12 months
To estimate the adherence to inclisiran and other non-statin lipid-lowering therapies (LLTs), as measured by the proportion of days covered (PDC), using prescription data
Measured: At Month 3, Month 6, Month 9, and Month 12
Age at randomization and age at first diagnosis of CHD
To describe the demographics and clinical characteristics of the inclisiran group and the SoC group.
Measured: 12 months
Sex
To describe the demographics and clinical characteristics of the inclisiran group and the SoC group
Measured: 12 months
Temperature
To describe the demographics and clinical characteristics of the inclisiran group and the SoC group
Measured: 12 months
Respiratory rate
To describe the vital signs characteristics of inclisiran group and the SoC group. It will be measured manually or with an electrocardiogram monitor.
Measured: 12 months
Blood pressure
To describe the demographics and clinical characteristics of the inclisiran group and the SoC group
Measured: 12 months
Heart rate
To describe the demographics and clinical characteristics of the inclisiran group and the SoC group
Measured: 12 months
Previous lipid-lowering therapies (LLTs), through Adherence Assessment Questionnaire (AAQ)
The AAQ is a generic instrument for assessing non-adherence (NA) in chronic conditions, consists of 11 items in total. Ten of these items are phrased as statements and use a 4-point Likert scale, offering the response options: Strongly agree, Generally agree, Generally disagree, and Strongly disagree. Each item is scored from 1 to 4, with a higher score indicating a greater likelihood of non-adherence.
Measured: 12 months
Previous lipid-lowering therapies (LLTs), through Adherence Barriers Questionnaire (ABQ)
The ABQ consists of 16 items, each addressing a specific adherence barrier. All items are formulated as statements. A 4-point Likert scale is used, deliberately omitting a neutral response option to encourage decisive answers. The available response options are: Strongly agree, Generally agree, Generally disagree, and Strongly disagree. Each response is assigned a value from 1 to 4 or 4 to 1, depending on the wording of the item, ensuring that a higher score reflects a stronger influence of a specific barrier on the patient's perception. The total score ranges from 16 (minimum) to 64 (maximum).Based on patient responses, both a general ABQ score and item- or subscale-specific scores can be calculated, indicating the number and strength of adherence barriers experienced by a patient.
Measured: 12 months
Dose, frequency, and treatment duration of inclisiran in the inclisiran group and of other LLTs in the SoC group
To describe the treatment patterns of inclisiran and other LLTs
Measured: 12 months
LDL-C variability in the inclisiran group by average successive variability (ASV), coefficient of variation (CV), and variation independent of mean (VIM)
To evaluate LDL-C variability in the inclisiran group
Measured: 12 months
Subsequent LLTs for participants who discontinued/switched the assigned treatment
To describe the treatment patterns of inclisiran and other LLTs
Measured: 12 months
Concomitant lipid lowering treatments
To describe the treatment patterns of inclisiran and other LLTs
Measured: 12 months
Treatment satisfaction from Treatment Satisfaction Questionnaire for Medication (TSQM)
This scale includes four dimensions: drug treatment effectiveness, adverse reactions, convenience, and overall satisfaction. Whether the patient has experienced adverse drug reactions is scored using "yes" and "no"; The adverse reaction dimension is evaluated using a Likert-5 scale, with scores ranging from 1 to 5 indicating "extremely dissatisfied" to "not dissatisfied at all"; The effectiveness, convenience, and overall satisfaction are rated on a Likert-7 scale, with scores ranging from 1 to 7 indicating "extremely dissatisfied" and "extremely satisfied", respectively. The standard score for each dimension is 100 points, and the higher the score, the higher the patient's satisfaction with drug treatment.
Measured: At Month 6 and Month 12
The average PDCinclisiran in the inclisiran group and the average PDCnon-statin in the SoC group, from patient questionnaire data, at 3 months, 6 months, 9 months, and 12 months
To assess treatment satisfaction and adherence by questionnaires
Measured: At Month 3, Month 6, Month 9, and Month 12
Incidence of adverse events (AEs), serious adverse events (SAEs)
To evaluate the safety of Inclisiran
Measured: 12 months
Number of participants with relevant medical history
To describe the demographics and clinical characteristics of the inclisiran group and the SoC group
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start17 Jun 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- None (open label)
- Enrolment
- 1,590 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941792
- Sponsor's protocol ID
- CKJX839A1CN06
- Acronym
- V-INVINCIBLE
- Status last verified
- May 2026
- First submitted
- 6 Mar 2025
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Inclisiran for Patients With Coronary Heart Disease in China: a Multicenter, Standard of Care-Controlled Pragmatic Randomized Trial
- ClinicalTrials.gov ID
- NCT06941792
- Acronym / sponsor ID
- V-INVINCIBLE / CKJX839A1CN06
- Conditions
- Coronary Heart Disease
- Keywords
- Inclisiran, effectiveness, lipid-lowering, low-density lipoprotein cholesterol Test on Target
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,590 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 24 Apr 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.
The current study will be conducted to evaluate the real-world effectiveness of inclisiran relative to standard of care (SoC) in Chinese patients with coronary heart disease (CHD), not only with the low-density lipoprotein cholesterol (LDL-C) change in 1 year, but also the LDL-C Test on Target for 1 year. This study further aims to assess the adherence, treatment patterns and satisfaction, and safety of inclisiran among Chinese patients.
Detailed description
The study is a multicenter, randomized, parallel, open-label, pragmatic trial, to assess the effectiveness of inclisiran in the real-world compared to SoC, in patients with CHD in China who did not achieve LDL-C goal despite maximally tolerated statin therapy for ≥4weeks stable using. CHD patients include patients with acute coronary syndrome and patients with chronic coronary syndrome.
After granting informed consent, being screened, and confirmed eligible for the study, participants will be randomized to 2 arms (inclisiran or SoC) in a 1:1 ratio.
Following the randomization, participants start inclisiran or SoC adaptation (which means switching to or adding on another/other lipid-lowering therapies (LLT[s]). This start date is defined as Day 0.
During follow-up, each participant will follow routine care, and the results of LDL-C tests will be collected for each Visit (every 3 months), with an allowable window of ±1.5 months. Each patient will be followed up until his/her end of study (EOS), which is the earliest of the end of follow-up period (Visit 4: approximately 12 months following Day 0), lost to follow-up, consent withdrawal, death, and participating in another interventional trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inclisiran group | Experimental | Drug: inclisiran sodium injectionpatients in the inclisiran group will receive inclisiran (may or may not plus cholesterol absorption inhibitor at the discretion of the treating physician). |
| Standard of Care group | Active comparator | Combination Product: Standard of CarePatients in the SoC group will switch to/add on another/other LLT(s) at the discretion of the treating physician, as long as it is not inclisiran or an investigational drug. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent must be obtained prior to participation in the study
- Documented diagnosis of CHD prior to screening, including acute coronary syndrome (ACS) and chronic coronary syndrome (CCS)
- Aged ≥18 years at randomization
- Despite maximally tolerated statin therapy for ≥4weeks stable using prior to screening, LDL-C result at screening not at goal (≥1.8 mmol/L).
- The maximum tolerated dose of statins also includes patients with statin intolerance or contraindication.
Key exclusion criteria (6 listed)
- Received inclisiran during the 2 years prior to the screening.
- Received proprotein convertase subtilisin-kexin type 9 (PCSK9) mabs during the 3 months prior to screening.
- Participating in an interventional trial at enrollment
- Having severe liver disorder (Child-Pugh class C)
- Any other condition that may put the participant at significant risk if the participant participate in the current study, according to investigator's (or delegate's) judgment.
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 sodium injectionAfter randomization, patients in the inclisiran group will receive inclisiran sodium injection | Drug | inclisiran group |
| Standard of CareAfter randomization switching to or adding on another/other lipid-lowering therapies | Combination product | Standard of Care group |
Primary outcome
The percentage change in low-density lipoprotein cholesterol (LDL-C) level from baseline at 12 months, for the inclisiran group versus the standard of care (SoC) group
Time frame: 12 months
To evaluate the real-world effectiveness of inclisiran, on the change in LDL-C levels at Month 12, compared with SoC, in Chinese patients with coronary heart disease (CHD)
25 secondary outcomes
The proportion of participants with the 1-year LDL-C Test on Target ≥75%, for the inclisiran group versus the SoC group
Time frame: 12 months
The percentage change in LDL-C level from baseline at 3 months, 6 months, and 9 months, for the inclisiran group versus the SoC group
Time frame: At Month 3, Month 6 and Month 9
The proportion of participants with LDL-C <1.8 mmol/L at 12 months, for the inclisiran group versus the SoC group
Time frame: 12 months
To describe LDL-C Test on Target value during the 12 months after baseline, for the inclisiran group and the SoC group.
Time frame: 12 months
The percentage change in levels of total cholesterol, triglyceride, HDL-C, Lp(a), ApoA, and ApoB, from baseline at 3 months, 6 months, 9 months, and 12 months, for the inclisiran group versus the SoC group
Time frame: At Month 3, Month 6, Month 9, and Month 12
Area under the curve (AUC) of LDL-C level versus time (from 0 months to 12 months), for the inclisiran group versus the SoC group
Time frame: Baseline, 12 months
The proportion of participants with PDCinclisiran≥80% in the inclisiran group and the proportion of participants with PDCnon-statin≥80% in the SoC group, at 3 months, 6 months, 9 months, and 12 months
Time frame: At Month 3, Month 6, Month 9, and Month 12
The average number of days covered, of inclisiran in the inclisiran group and of non-statin lipid-lowering therapies (LLTs) in the SoC group, at 3 months, 6 months, 9 months, and 12 months
Time frame: At Month 3, Month 6, Month 9, and Month 12
The average PDCinclisiran in the inclisiran group and the average PDCnon-statin in the SoC group, at 3 months, 6 months, 9 months, and 12 months
Time frame: At Month 3, Month 6, Month 9, and Month 12
Age at randomization and age at first diagnosis of CHD
Time frame: 12 months
Sex
Time frame: 12 months
Temperature
Time frame: 12 months
Respiratory rate
Time frame: 12 months
Blood pressure
Time frame: 12 months
Heart rate
Time frame: 12 months
Previous lipid-lowering therapies (LLTs), through Adherence Assessment Questionnaire (AAQ)
Time frame: 12 months
Previous lipid-lowering therapies (LLTs), through Adherence Barriers Questionnaire (ABQ)
Time frame: 12 months
Dose, frequency, and treatment duration of inclisiran in the inclisiran group and of other LLTs in the SoC group
Time frame: 12 months
LDL-C variability in the inclisiran group by average successive variability (ASV), coefficient of variation (CV), and variation independent of mean (VIM)
Time frame: 12 months
Subsequent LLTs for participants who discontinued/switched the assigned treatment
Time frame: 12 months
Concomitant lipid lowering treatments
Time frame: 12 months
Treatment satisfaction from Treatment Satisfaction Questionnaire for Medication (TSQM)
Time frame: At Month 6 and Month 12
The average PDCinclisiran in the inclisiran group and the average PDCnon-statin in the SoC group, from patient questionnaire data, at 3 months, 6 months, 9 months, and 12 months
Time frame: At Month 3, Month 6, Month 9, and Month 12
Incidence of adverse events (AEs), serious adverse events (SAEs)
Time frame: 12 months
Number of participants with relevant medical history
Time frame: 12 months
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 29 May 2026.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
19 sites 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 injection in people with Coronary Heart Disease, run by Novartis Pharmaceuticals at 19 sites 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 5 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites 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?
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?
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?
The percentage change in low-density lipoprotein cholesterol (LDL-C) level from baseline at 12 months, for the inclisiran group versus the standard of care (SoC) group (time frame: 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 29 May 2026.