Acute Coronary SyndromePhase 4NCT07684469
Comparative Assessment of Inclisiran on Top of Standard of Care Versus Standard of Care Alone for LDL-C Evaluation in Acute Coronary Syndrome Patients in Saudi Arabia
A Phase 4 study testing inclisiran and SOC in people with Acute Coronary Syndrome, run by Novartis Pharmaceuticals.
Trial summary
This study aims to evaluate the effectiveness and safety of implementing a systematic augmented low-density lipoprotein cholesterol (LDL-C) management care pathway initiated in hospitals for patients with Acute Coronary Syndrome. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- inclisiran and SOC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2026to 28 Feb 2029
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants eligible for inclusion in this study must meet all of the following criteria:
- Males and females ≥18 years of age.
- Recent ACS (in-patient/out-patient) within 7 days of index admission, as per 2023 ESC guidelines for the management of acute coronary syndrome
- Serum LDL-C ≥1.8 mmol/L (≥70 mg/dL) or non-HDL ≥100 mg/dL at screening for participants who were receiving SOC [including lipid lowering therapy and/or ezetimibe] prior enrollment.
- Serum LDL-C ≥2.6 mmol/L (≥100 mg/dL) or non-HDL ≥124 mg/dL at screening for participants who were SOC treatment naïve prior enrollment.
- Fasting triglycerides <4.52 mmol/L (<400 mg/dL) at screening.
- Estimated glomerular filtration rate (eGFR) >30 mL/min at screening.
- Participants must be willing and able to give informed consent before initiation of any study related procedures and willing to comply with all required study procedures.
Who cannot join
- Participants meeting any of the following criteria are not eligible for inclusion in this study:
- Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with participation in the clinical study and/or put the participant at significant risk (according to investigator's [or delegate] judgment) if he/she participates in the clinical study.
- An underlying known disease, or surgical, physical, or medical condition that, in the opinion of the investigator (or delegate) might interfere with interpretation of the clinical study results.
- New York Heart Association (NYHA) class IIIb or IV heart failure or last known left ventricular ejection fraction <25%.
- Significant cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication or via ablation at the time of screening.
- Uncontrolled severe hypertension: systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg prior to randomization (assessed at screening visit) despite antihypertensive therapy.
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- Homozygous familial hypercholesterolemia (HoFH) defined as LDL-C ≥ 12 mmol/L.
- Statin intolerant patients defined as documented side effects on 2 different statins, including one at the lowest standard dose.
- Severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 2 years.
- History of malignancy that required surgery (excluding local and wide-local excision), radiation therapy and/or systemic therapy during the three years prior to randomization.
- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral salpingectomy at least six weeks before taking study treatment. In the case of oophorectomy alone, the reproductive status of the woman needs to have been confirmed by follow-up hormone level assessment. Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., hormonal profile confirming menopause and/or age-appropriate history of vasomotor symptoms).
- Breastfeeding women.
- Treatment with other investigational products or devices within 30 days or five half-lives of the screening visit, whichever is longer.
- History of hypersensitivity to any of the study treatments or its excipients, or to drugs of similar chemical classes (statins, ezetimibe, and inclisiran).
- Planned use of other investigational products or devices during the course of the study.
- Any condition that, according to the investigator, could interfere with the conduct of the study, such as but not limited to:
- Participants who are unable to communicate or to cooperate with the investigator.
- Unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study (including participants whose cooperation is doubtful due to drug abuse or alcohol dependency).
- Unlikely to comply with the protocol requirements, instructions, and study-related restrictions (e.g., uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study).
- Persons directly involved in the conduct of the study.
- Treatment with monoclonal antibodies directed towards PCSK9 or inclisiran within 60 days of screening or planned use of it as SOC during next 210 days.
- Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or (ii) alanine aminotransferase (ALT) elevation >3x ULN, aspartate aminotransferase (AST) elevation >3x ULN, or total bilirubin elevation >2x ULN (except patients with Gilbert's syndrome) at screening confirmed by a repeat measurement at least one week apart.
- Uncontrolled Diabetes Mellitus (DM) defined as HbA1c > 9%.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
About this study
Official title: Comparative, Randomized, Multicenter, Followed by an Open Label Extension Trial in Patients With a Recent Acute Coronary Syndrome Evaluating the Early Inclusion of Inclisiran Into Standard of Care Versus Standard of Care Alone in Kingdom of Saudi Arabia
This study aims to evaluate the effectiveness and safety of implementing a systematic augmented low-density lipoprotein cholesterol (LDL-C) management care pathway initiated in hospitals for patients with Acute Coronary Syndrome. This pathway includes treatment with inclisiran on top of the standard of care (SOC), which consists of statins with or without ezetimibe, compared to a high-intensity SOC regimen alone (statins +/- ezetimibe).
Read the detailed description
This multi-center phase IV study adopted a two-phase design. The first phase (Day 1 to Day 90) is an open-label, randomized, comparative parallel-group design comparing an LDL-C management strategy that includes inclisiran with SOC versus SOC alone. The second phase is an open-label extension design (Day 90 to Day 210). After the EOI visit, the participants from phase 2 will be invited to participate in a 1-year long-term observational phase to assess medication adherence and satisfaction.
- Conditions
- Acute Coronary Syndrome
- Being tested
- inclisiran, SOC
- Keywords
- Hyperlipidemia, Recent acute coronary syndrome, Lipid lowering therapies
- Medical subject headings
- Acute Coronary Syndrome, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inclisiranDrug
Also called KJX839
Inclisiran sodium 300 mg
SOCDrug
consists of statins with or without ezetimibe, compared to a high-intensity SOC regimen alone (statins +/- ezetimibe)
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: inclisiran + SOC | Experimental | Inclisiran sodium 300 mg administered on Day 1 and Day 90 on top of standard of care (SOC) Receives: Drug: inclisiran; Drug: SOC |
| Phase 1: SOC | Active comparator | standard of care (SOC) alone Receives: Drug: SOC |
| Phase 2: inclisiran + SOC | Experimental | Inclisiran sodium 300 mg administered on Day 90 and Day 180 for switched group (SOC alone group from first phase) on top of SOC Receives: Drug: inclisiran; Drug: SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in LDL-C from baseline at Day 60
Difference in percent change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) between inclisiran + SOC group and SOC alone group
Measured: Baseline and Day 60
Secondary outcomes (16)
Absolute change from baseline in LDL-C levels
Absolute change from baseline in LDL-C levels in the inclisiran + SOC group compared to SOC group at Days 14, 30, 60, 90 in phase 1 and Day 150 in all participants in phase 2
Measured: Baseline, Day 14, Day 30, Day 60, Day 90 in phase 1 and Day 150 in phase 2
Average percent change from baseline in LDL-C levels
Average percent change from baseline in LDL-C levels in the inclisiran + SOC group compared to SOC group at Days 14, 30, 60, 90 in phase 1 and Day 150 in all participants in phase 2.
Measured: Baseline, Day 14, Day 30, Day 60, Day 90 in phase 1 and Day 150 in phase 2
Average absolute change from baseline in LDL-C levels
Average absolute change from baseline in LDL-C levels in the inclisiran + SOC group compared to SOC group at Days 14, 30, 60, 90 in phase 1 and Day 150 in all participants in phase 2.
Measured: Baseline, Day 14, Day 30, Day 60, Day 90 in phase 1 and Day 150 in phase 2
Proportion of participants achieving LDL-C levels <1.4 mmol/L
Proportion of participants achieving LDL-C levels <1.4 mmol/L in each treatment group (inclisiran + SOC vs. SOC alone) at Days 30, 60, 90 in phase 1 and Day 150 in all participants in phase 2.
Measured: Day 30, Day 60, Day 90 in phase 1 and Day 150 in phase 2
Proportion of participants achieving LDL-C levels <1.8 mmol/L
Proportion of participants achieving LDL-C levels <1.8 mmol/L in each treatment group (inclisiran + SOC vs. SOC alone) at Days 30, 60, 90 in phase 1 and Day 150 in all participants in phase 2.
Measured: Day 30, Day 60, Day 90 in phase 1 and Day 150 in phase 2
Absolute change from baseline in VLDL, non-HDL-C, TC, HDL-C and TG
Absolute change from baseline in very low-density lipoprotein (VLDL), non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C) and triglycerides (TG) in the inclisiran + SOC group compared to the SOC group at Day 90 in phase 1
Measured: Baseline and Day 90
Absolute change from baseline in Lp(a)
Absolute change from baseline in lipoprotein(a) (Lp(a)) in the inclisiran + SOC group compared to the SOC group at Day 90 in phase 1
Measured: Baseline and Day 90
Proportion of participants needing additional lipid lowering therapy
Proportion of participants needing additional lipid lowering therapy in the inclisiran + SOC group compared to the SOC group at Day 90 in phase 1 and Day 150 in all participants in phase 2.
Measured: Day 90 in phase 1 and Day 150 in phase 2
Average percent change in LDL-C levels
Average percent change in LDL-C levels in the inclisiran + SOC group compared to the SOC group between Day 30 and Day 90 in phase 1 and Day 150 in all participants in phase 2
Measured: Between Day 30 and Day 90 in phase 1 and Day 150 in phase 2
Average absolute change in LDL-C levels
Average absolute change in LDL-C levels in the inclisiran + SOC group compared to the SOC group between Day 30 and Day 90 in phase 1 and Day 150 in all participants in phase 2.
Measured: Between Day 30 and Day 90 in phase 1 and Day 150 in phase 2
Proportion of participants achieving a target LDL-C level <1.4 mmol/L
Proportion of participants achieving a target LDL-C level <1.4 mmol/L in all participants in Phase 2 at Day 210.
Measured: Day 210
Proportion of participants achieving a target LDL-C level <1.8 mmol/L
Proportion of participants achieving a target LDL-C level <1.8 mmol/L in all participants in Phase 2 at Day 210.
Measured: Day 210
Average percent change from baseline in LDL-C levels
Average percent change from baseline in LDL-C levels in all participants in Phase 2 at Day 210.
Measured: Day 210
Average absolute change from baseline in LDL-C levels
Average absolute change from baseline in LDL-C levels in all participants in Phase 2 at Day 210
Measured: Day 210
Number of participants with AEs and SAEs
Number of participants with adverse events (AEs), serious adverse events (SAEs), including abnormal values in hematology evaluation, blood chemistry and urine, vital signs, and physical examinations.
Measured: Up to 210 days
Mean score in the Treatment Satisfaction Questionnaire for Medication (TSQMII)
The Treatment Satisfaction Questionnaire about Medication (TSQMII) version II is a validated 11 item scale which, in this study, will assess a patients' satisfaction (with regard to their lipid lowering treatments), providing scores on four scales: 1) side effects, 2) effectiveness, 3) convenience and 4) global, overall, satisfaction.
TSQMII assesses patients' satisfaction with medication with a higher score, reflecting greater overall satisfaction (1=extremely dissatisfied and 7=extremely satisfied)
Measured: Day 210
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start31 Oct 2026 (estimated)
- Primary completion29 Feb 2028 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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
- 300 participants (estimated)
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
- NCT07684469
- Sponsor's protocol ID
- CKJX839A1SA03
- Status last verified
- Oct 2026
- First submitted
- 29 Jun 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative, Randomized, Multicenter, Followed by an Open Label Extension Trial in Patients With a Recent Acute Coronary Syndrome Evaluating the Early Inclusion of Inclisiran Into Standard of Care Versus Standard of Care Alone in Kingdom of Saudi Arabia
- ClinicalTrials.gov ID
- NCT07684469
- Acronym / sponsor ID
- CKJX839A1SA03
- Conditions
- Acute Coronary Syndrome
- Keywords
- Hyperlipidemia, Recent acute coronary syndrome, Lipid lowering therapies
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 6 Jul 2026 (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.
This study aims to evaluate the effectiveness and safety of implementing a systematic augmented low-density lipoprotein cholesterol (LDL-C) management care pathway initiated in hospitals for patients with Acute Coronary Syndrome. This pathway includes treatment with inclisiran on top of the standard of care (SOC), which consists of statins with or without ezetimibe, compared to a high-intensity SOC regimen alone (statins +/- ezetimibe).
Detailed description
This multi-center phase IV study adopted a two-phase design. The first phase (Day 1 to Day 90) is an open-label, randomized, comparative parallel-group design comparing an LDL-C management strategy that includes inclisiran with SOC versus SOC alone. The second phase is an open-label extension design (Day 90 to Day 210). After the EOI visit, the participants from phase 2 will be invited to participate in a 1-year long-term observational phase to assess medication adherence and satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1: inclisiran + SOC | Experimental | Drug: inclisiran, Drug: SOCInclisiran sodium 300 mg administered on Day 1 and Day 90 on top of standard of care (SOC) |
| Phase 1: SOC | Active comparator | Drug: SOCstandard of care (SOC) alone |
| Phase 2: inclisiran + SOC | Experimental | Drug: inclisiran, Drug: SOCInclisiran sodium 300 mg administered on Day 90 and Day 180 for switched group (SOC alone group from first phase) on top of SOC |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants eligible for inclusion in this study must meet all of the following criteria:
- Males and females ≥18 years of age.
- Recent ACS (in-patient/out-patient) within 7 days of index admission, as per 2023 ESC guidelines for the management of acute coronary syndrome
- Serum LDL-C ≥1.8 mmol/L (≥70 mg/dL) or non-HDL ≥100 mg/dL at screening for participants who were receiving SOC [including lipid lowering therapy and/or ezetimibe] prior enrollment.
- Serum LDL-C ≥2.6 mmol/L (≥100 mg/dL) or non-HDL ≥124 mg/dL at screening for participants who were SOC treatment naïve prior enrollment.
Key exclusion criteria (24 listed)
- Participants meeting any of the following criteria are not eligible for inclusion in this study:
- Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with participation in the clinical study and/or put the participant at significant risk (according to investigator's [or delegate] judgment) if he/she participates in the clinical study.
- An underlying known disease, or surgical, physical, or medical condition that, in the opinion of the investigator (or delegate) might interfere with interpretation of the clinical study results.
- New York Heart Association (NYHA) class IIIb or IV heart failure or last known left ventricular ejection fraction <25%.
- Significant cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication or via ablation at the time of screening.
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 |
|---|---|---|
| inclisiranAlso: KJX839Inclisiran sodium 300 mg | Drug | Phase 1: inclisiran + SOC, Phase 2: inclisiran + SOC |
| SOCconsists of statins with or without ezetimibe, compared to a high-intensity SOC regimen alone (statins +/- ezetimibe) | Drug | Phase 1: SOC, Phase 1: inclisiran + SOC, Phase 2: inclisiran + SOC |
Primary outcome
Percent change in LDL-C from baseline at Day 60
Time frame: Baseline and Day 60
Difference in percent change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) between inclisiran + SOC group and SOC alone group
16 secondary outcomes
Absolute change from baseline in LDL-C levels
Time frame: Baseline, Day 14, Day 30, Day 60, Day 90 in phase 1 and Day 150 in phase 2
Average percent change from baseline in LDL-C levels
Time frame: Baseline, Day 14, Day 30, Day 60, Day 90 in phase 1 and Day 150 in phase 2
Average absolute change from baseline in LDL-C levels
Time frame: Baseline, Day 14, Day 30, Day 60, Day 90 in phase 1 and Day 150 in phase 2
Proportion of participants achieving LDL-C levels <1.4 mmol/L
Time frame: Day 30, Day 60, Day 90 in phase 1 and Day 150 in phase 2
Proportion of participants achieving LDL-C levels <1.8 mmol/L
Time frame: Day 30, Day 60, Day 90 in phase 1 and Day 150 in phase 2
Absolute change from baseline in VLDL, non-HDL-C, TC, HDL-C and TG
Time frame: Baseline and Day 90
Absolute change from baseline in Lp(a)
Time frame: Baseline and Day 90
Proportion of participants needing additional lipid lowering therapy
Time frame: Day 90 in phase 1 and Day 150 in phase 2
Average percent change in LDL-C levels
Time frame: Between Day 30 and Day 90 in phase 1 and Day 150 in phase 2
Average absolute change in LDL-C levels
Time frame: Between Day 30 and Day 90 in phase 1 and Day 150 in phase 2
Proportion of participants achieving a target LDL-C level <1.4 mmol/L
Time frame: Day 210
Proportion of participants achieving a target LDL-C level <1.8 mmol/L
Time frame: Day 210
Average percent change from baseline in LDL-C levels
Time frame: Day 210
Average absolute change from baseline in LDL-C levels
Time frame: Day 210
Number of participants with AEs and SAEs
Time frame: Up to 210 days
Mean score in the Treatment Satisfaction Questionnaire for Medication (TSQMII)
Time frame: Day 210
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 30 Oct 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.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing inclisiran and SOC in people with Acute Coronary Syndrome, run by Novartis Pharmaceuticals.
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 8 inclusion and 24 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: opening soon, as of the sponsor's last update on 30 Oct 2026. 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.
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 Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in LDL-C from baseline at Day 60 (time frame: Baseline and Day 60). 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 30 Oct 2026.