Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Partic… (NCT04873934) | Clinical Trial Compass
CompletedPhase 3
Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary Syndrome
United States400 participantsStarted 2021-06-24
Plain-language summary
The purpose of this study is to study the effectiveness of implementation of a systematic LDL-C management pathway including treatment with inclisiran in participants who have experienced a recent acute coronary syndrome (ACS) and have an increased LDL-cholesterol (≥70 mg/dL) despite being treated with a statin drug.
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:
* Recent Acute Coronary Syndrome (in-patient/out-patient) within 5 weeks of screening
* Serum LDL-C ≥70 mg/dL or non-HDL-C ≥100 mg/dL
* Fasting triglycerides \<4.52 mmol/L (\<400 mg/dL) at screening
* Calculated glomerular filtration rate \>20 mL/min by estimated glomerular filtration rate (eGFR)
* Participants are required to be discharged on statin therapy, or have documented statin intolerance, as determined by the investigator, following hospitalization for an ACS. Statin intolerant participants are eligible if they had intolerable side effects on at least 2 different statins, including one at the lowest standard dose
Exclusion Criteria:
* 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.
* Severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 2 years.
* Treatment with other investigational products or devices within 30 days or five half˗lives of the screening visit, whichever is longer.
* Planned use of other investigational products or devices during the course of the study.
* Treatment with monoclonal antibodies directed towards PCSK9 within 90 days of screening.
* Recurrent ACS event within 2 weeks prior to randomization.
* Coronary angiography and revascularization procedu…
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.