Inclisiran for Acute Coronary Syndrome
(ACS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests inclisiran, a medication that might benefit individuals with serious heart problems, particularly those hospitalized due to acute coronary syndromes, such as heart attacks or severe chest pain. The researchers aim to determine if inclisiran, administered soon after hospital admission alongside standard treatments, proves more effective than a placebo. Participants should have recently been hospitalized for a heart attack and have high LDL cholesterol levels, even if they are already on medication. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.
Is there any evidence suggesting that inclisiran is likely to be safe for humans?
Research shows that inclisiran is generally safe and well-tolerated, with studies finding a strong safety record. Serious side effects rarely occur, though some people report reactions at the injection site. While minor discomfort may occur, most do not experience serious health issues from the treatment. Inclisiran is already approved for managing cholesterol levels, and researchers are further studying its use for heart conditions. This existing approval for cholesterol management suggests it is safe to use.12345
Why do researchers think this study treatment might be promising for acute coronary syndrome?
Inclisiran is unique because it targets PCSK9, a protein that affects LDL cholesterol levels, using a new mechanism called RNA interference. This allows Inclisiran to effectively lower cholesterol with just two doses a year, which is a significant departure from the daily or weekly regimens of most current treatments like statins. Researchers are excited about Inclisiran because it offers a convenient, long-lasting alternative for patients, especially those who are intolerant to statins, while potentially reducing the risk of cardiovascular events.
What evidence suggests that inclisiran might be an effective treatment for acute coronary syndrome?
Research has shown that inclisiran can lower LDL cholesterol, often called "bad" cholesterol, by about 50%. This reduction helps patients reach cholesterol levels recommended by doctors. In this trial, some participants will receive inclisiran alongside their standard treatment. Previous studies have associated inclisiran with fewer major heart problems and hospital visits. More than half of the patients taking inclisiran achieved their LDL cholesterol goals, compared to fewer patients with standard care. These findings suggest that inclisiran could be a good option for improving heart health in people with serious heart issues.16789
Who Is on the Research Team?
Novartis Pharmaceuticals
Principal Investigator
Novartis Pharmaceuticals
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Randomization/Baseline
Randomization and baseline assessments occur before or at the day of discharge
Double-blind Treatment
Participants receive inclisiran or placebo treatment for 150 days
Follow-up
Safety follow-up call to monitor participants after the end of study visit
What Are the Treatments Tested in This Trial?
Interventions
- Inclisiran
- Placebo
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
* Inclisiran sodium 300 mg subcutaneous (s.c.) on top of HIS (+/- LLT) or non-statin LLT in statin intolerant participants * KJX839 284 mg / 1.5 mL (Dose: 300 mg) * Pharmaceutical Dosage Form: solution for subcutaneous injection
* Matching placebo on top of HIS (+/- LLT) or non-statin LLT in statin intolerant participants * KJX839 Placebo / 1.5 mL (Dose: 0 mg) * Pharmaceutical Dosage Form: solution for subcutaneous injection
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD
Citations
Inclisiran for fast-track lipid-lowering treatment early after an ...
This pilot study shows promise for inclisiran as a novel therapeutic option to improve cardiovascular outcomes in patients with ACS by ...
efficacy and adherence of inclisiran in post-acute coronary ...
LDL-C levels were reduced by approximately 50%, enabling 100% of the cohort to achieve guideline-recommended LDL-C goals. The only side effect ...
Inclisiran Linked to Lower MACE, AMI Rates in High-Risk ...
When added to maximally tolerated statin therapy, inclisiran was associated with significant reductions in MACE and hospitalizations among ...
Inclisiran in a real-world single-center registry of patients ...
A mean relative 50 % reduction of LDL cholesterol (LDLc) levels was observed in randomized studies in patients treated with inclisiran, ...
5.
bjcardio.co.uk
bjcardio.co.uk/2026/04/real-world-efficacy-of-inclisiran-data-from-a-tertiary-lipid-clinic/Real-world efficacy of inclisiran: data from a tertiary lipid clinic
Inclisiran therapy resulted in a mean LDL-C reduction of 48.4% following the first dose, sustained over 27 months. Patients receiving three or ...
EFFICACY AND SAFETY OF INCLISIRAN IN OUTPATIENTS ...
Our data suggests that inclisiran 284 mg plus usual care is effectiveness in the management of patients with elevated LDL–C post–ACS despite receiving statin ...
Safety Data on PCSK9i Inclisiran
From a safety standpoint, inclisiran has demonstrated a strong profile across its clinical development program. Serious adverse events have been ...
Safety and Tolerability of Inclisiran for Treatment ...
This analysis indicates that long-term inclisiran is safe and generally well tolerated in a diverse population of patients with dyslipidemia ...
Evaluation of Efficacy and Safety of Early in Hospital ...
The purpose of this trial is to learn about the effects of inclisiran in people with serious heart conditions (acute coronary syndromes), ...
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