Comparative Assessment of Inclisiran on Top of Standard of Care Versus Standard of Care Alone for… (NCT07684469) | Clinical Trial Compass
Not Yet RecruitingPhase 4
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
300 participantsStarted 2026-06-30
Plain-language 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).
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
Exclusion criteria
. 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.
. 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.