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Not yet recruitingNCT07684469Updated Oct 30, 2026

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 interventional study of inclisiran and SOC in Acute Coronary Syndrome, sponsored by Novartis Pharmaceuticals. Not yet recruiting. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 4, Interventional, and Treatment

Updated Oct 30, 2026Start date movedPrimary completion moved+1 moreGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Acute Coronary Syndrome

Keywords

  • Hyperlipidemia
  • Recent acute coronary syndrome
  • Lipid lowering therapies
03

In context

Acute Coronary Syndrome

1,488 studies on the registry are indexed under Acute Coronary Syndrome; 273 are open to participants now.

This study's planned enrollment of 300 is above the median of 200 across 865 interventional studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.

Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.

Browse Novartis Pharmaceuticals studies →All Novartis studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Participants eligible for inclusion in this study must meet all of the following criteria:

  1. Males and females ≥18 years of age.
  2. Recent ACS (in-patient/out-patient) within 7 days of index admission, as per 2023 ESC guidelines for the management of acute coronary syndrome
  3. 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.
  4. 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.
  5. Fasting triglycerides \<4.52 mmol/L (\<400 mg/dL) at screening.
  6. Estimated (eGFR) >30 mL/min at screening.
  7. Participants must be willing and able to give before initiation of any study related procedures and willing to comply with all required study procedures.

Exclusion criteria

Exclusion Criteria:

Participants meeting any of the following criteria are not eligible for inclusion in this study:

  1. 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.
  2. 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.
  3. (NYHA) class IIIb or IV heart failure or last known \<25%.
  4. Significant cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication or via ablation at the time of screening.
  5. Uncontrolled severe hypertension: systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg prior to randomization (assessed at screening visit) despite antihypertensive therapy.
  6. Homozygous familial hypercholesterolemia (HoFH) defined as LDL-C ≥ 12 mmol/L.
  7. Statin intolerant patients defined as documented side effects on 2 different statins, including one at the lowest standard dose.
  8. Severe concomitant non-cardiovascular disease that carries the risk of reducing to less than 2 years.
  9. History of that required surgery (excluding local and wide-local excision), radiation therapy and/or systemic therapy during the three years prior to randomization.
  10. Women of , defined as all women physiologically capable of becoming pregnant from menarche until becoming , 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).
  11. Breastfeeding women.
  12. Treatment with other products or devices within 30 days or five half-lives of the screening visit, whichever is longer.
  13. History of to any of the study treatments or its , or to drugs of similar chemical classes (statins, ezetimibe, and inclisiran).
  14. Planned use of other investigational products or devices during the course of the study.

  15. Any condition that, according to the investigator, could interfere with the conduct of the study, such as but not limited to:

    1. Participants who are unable to communicate or to cooperate with the investigator.
    2. 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).
    3. 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).
    4. Persons directly involved in the conduct of the study.
  16. 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.
  17. Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or (ii) (ALT) elevation >3x , aspartate aminotransferase (AST) elevation >3x ULN, or total elevation >2x ULN (except patients with Gilbert's syndrome) at screening confirmed by a repeat measurement at least one week apart.
  18. Uncontrolled Diabetes Mellitus (DM) defined as > 9%.

Other protocol-defined inclusion/exclusion criteria may apply

Terms in these criteria, in plain language(15)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Phase 1: inclisiran + SOC

    Inclisiran sodium 300 mg administered on Day 1 and Day 90 on top of standard of care (SOC)

    Drug: inclisiran · Drug: SOC

  • Active comparator
    Phase 1: SOC

    standard of care (SOC) alone

    Drug: SOC

  • Experimental
    Phase 2: inclisiran + SOC

    Inclisiran sodium 300 mg administered on Day 90 and Day 180 for switched group (SOC alone group from first phase) on top of SOC

    Drug: inclisiran · Drug: SOC

Interventions

  • Druginclisiran

    Inclisiran sodium 300 mg

    Also known as: KJX839

  • DrugSOC

    consists of statins with or without ezetimibe, compared to a high-intensity SOC regimen alone (statins +/- ezetimibe)

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline and Day 60

Secondary outcomes

  1. 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

    Time frame: Baseline, Day 14, Day 30, Day 60, Day 90 in phase 1 and Day 150 in phase 2

  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.

    Time frame: Baseline, Day 14, Day 30, Day 60, Day 90 in phase 1 and Day 150 in phase 2

  3. 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.

    Time frame: Baseline, Day 14, Day 30, Day 60, Day 90 in phase 1 and Day 150 in phase 2

  4. 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.

    Time frame: Day 30, Day 60, Day 90 in phase 1 and Day 150 in phase 2

  5. 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.

    Time frame: Day 30, Day 60, Day 90 in phase 1 and Day 150 in phase 2

  6. 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

    Time frame: Baseline and Day 90

  7. 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

    Time frame: Baseline and Day 90

  8. 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.

    Time frame: Day 90 in phase 1 and Day 150 in phase 2

  9. 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

    Time frame: Between Day 30 and Day 90 in phase 1 and Day 150 in phase 2

  10. 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.

    Time frame: Between Day 30 and Day 90 in phase 1 and Day 150 in phase 2

  11. 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.

    Time frame: Day 210

  12. 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.

    Time frame: Day 210

  13. 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.

    Time frame: Day 210

  14. 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

    Time frame: Day 210

  15. 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.

    Time frame: Up to 210 days

  16. 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)

    Time frame: Day 210

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: 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

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Feb 2028, 15 months later.

Of 92 phase 4 interventional studies under Acute Coronary Syndrome, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 60. This study's planned 15 months is below that.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 30, 2026: start Jun 2026 → Oct 2026, primary completion Feb 2027 → Feb 2028 and completion Oct 2028 → Feb 2029.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jun 29, 2026
First posted
Jul 6, 2026
StartEst.
Oct 31, 2026was Jun 2026
Primary completionEst.
Feb 29, 2028was Feb 2027
CompletionEst.
Feb 28, 2029was Oct 2028
Last update
Oct 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Jun 30, 2026→Oct 31, 2026
Oct 30, 2026
Primary completion
Feb 28, 2027→Feb 29, 2028
Oct 30, 2026
Study completion
Oct 31, 2028→Feb 28, 2029
Oct 30, 2026
Show all 1 update
  1. Oct 30, 2026
    Start date Jun 30, 2026→Oct 31, 2026
    Primary completion Feb 28, 2027→Feb 29, 2028
    Study completion Oct 31, 2028→Feb 28, 2029
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07684469
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Jul 6, 2026
Start date
Oct 31, 2026 (estimated)
Primary completion
Feb 29, 2028 (estimated)
Completion
Feb 28, 2029 (estimated)
Last update
Oct 30, 2026

Study contacts

Novartis Pharmaceuticals
Contact
novartis.email@novartis.com
+41613241111
Novartis Pharmaceuticals
Contact
Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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