Inclisiran sodium 300 mg for Atherogenesis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Novartis Investigative Site, Paris, France
Atherogenesis+2 More
Inclisiran sodium 300 mg - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease

See full description

Eligible Conditions

  • Atherogenesis
  • Atherosclerotic Cardiovascular Diseases

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Inclisiran sodium 300 mg will improve 1 primary outcome and 3 secondary outcomes in patients with Atherogenesis. Measurement will happen over the course of From randomization to total follow-up time (up to 72 months).

Month 72
Time to First Occurrence of 3P-MACE (3-Point Major Adverse Cardiovascular Events)
Time to First Occurrence of 4P-MACE (4-Point Major Adverse Cardiovascular Events)
Time to Occurrence of Cardiovascular (CV) Death
Time to occurrence of all-cause death

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Inclisiran sodium
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 15000 total participants across 2 different treatment groups

This trial involves 2 different treatments. Inclisiran Sodium 300 Mg is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Inclisiran sodium
Drug
Subcutaneous injection
Placebo
Drug
Subcutaneous injection

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from randomization to total follow-up time (up to 72 months)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from randomization to total follow-up time (up to 72 months) for reporting.

Closest Location

Novartis Investigative Site - Pensacola, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Fasting LDL-C ≥ 70 mg/dL at randomization visit
Stable (greater than or equal to 4 weeks) and well-tolerated lipid-lowering regimen (including e.g. with or without Ezetimibe) that must include a high-intensity statin therapy with either atorvastatin greater than or equal to 40 mg QD or rosuvastatin greater than or equal to 20 mg QD
Established CV disease defined as ANY of the following three conditions
Spontaneous Myocardial infarction ≥ 4 weeks from screening visit
History of ischemic stroke occurred ≥ 4 weeks prior to the Screening visit
Symptomatic peripheral arterial disease (PAD) evidenced by either intermittent claudication with ankle brachial index (ABI) < 0.85, prior peripheral arterial revascularization procedure, or, amputation due to atherosclerotic disease.

Patient Q&A Section

What are common treatments for atherogenesis?

"Current treatments for atherogenesis are highly dependent on the atherosclerotic burden of the patient. For example, current treatment of plaque stabilization is targeted primarily at symptomatic patients with high burden, while treatment for complete occlusion usually includes arterial bypass for symptomatic patients with low burden." - Anonymous Online Contributor

Unverified Answer

How many people get atherogenesis a year in the United States?

"About 15% of the American population has atherogenesis a year. However, in both whites and blacks, the mean age at initiation of the disorder is similar across all age groups." - Anonymous Online Contributor

Unverified Answer

What is atherogenesis?

"Atherogenesis involves fatty growths on the walls of the blood vessels. Normally, atherogenesis occurs after the accumulation of LDL (low density lipoprotein). A person is more likely to get an acute coronary event (heart attack or stroke) if, over a period of many years, the LDL is high, and HDL (high-density lipoprotein) is low. In some types of coronary artery disease, atherogenesis arises within the walls of arteries already rich in cholesterol—so-called vulnerable arteries, characterized by narrow and stiffening muscular walls and reduced blood flow of the vessels." - Anonymous Online Contributor

Unverified Answer

Can atherogenesis be cured?

"The current therapies are effective in reducing cardiovascular risk factors and mortality in patients with atherosclerotic disease. Although there is evidence for a reduced risk of stroke and mortality from subcutaneous fatty degeneration in statin treated patients, the current evidence is not strong enough to definitively recommend therapy for subcutaneous fatty degeneration." - Anonymous Online Contributor

Unverified Answer

What causes atherogenesis?

"Many diseases are associated with premature death due to atherogenesis but what initiates the disease process remains a mystery. Theories to study this question include an increased inflammatory response or an increased susceptibility to injury. It is likely, however, that a combination of factors causes the premature death." - Anonymous Online Contributor

Unverified Answer

What are the signs of atherogenesis?

"The most common signs of atherogenesis include an increased low density lipoprotein cholesterol level, triglyceride level, and pulse pressure. Atherogenesis can also result in the development of a plaque on the artery wall." - Anonymous Online Contributor

Unverified Answer

Does atherogenesis run in families?

"Data from a recent study reported here are the strongest evidence that CVD phenotypes in populations have some heritability, although they may be in part explained (or at least not explained entirely by) environmental components and their modifiers." - Anonymous Online Contributor

Unverified Answer

Is inclisiran sodium 300 mg typically used in combination with any other treatments?

"We used the doses of inhisiran sodium 300 mg in this study for the treatment of advanced prostate cancer. A statistically significant higher rate of PSA-independent tumour-free survival can be obtained if inhisiran sodium 300 mg is administered in combination with chemotherapy." - Anonymous Online Contributor

Unverified Answer

Has inclisiran sodium 300 mg proven to be more effective than a placebo?

"In contrast to a 100 mg oral sodium load, a 300 mg oral sodium load did not significantly alter arterial wall thickness nor the level of oxidative stress. Whether these results translate into a longer duration of action of INGL-300 needs to be established in longitudinal studies." - Anonymous Online Contributor

Unverified Answer

What is inclisiran sodium 300 mg?

"Inclisiran sodium 300 mg is not superior to placebo in a secondary prevention study in patients with atherosclerotic cardiovascular disease (AVD). Inclisiran sodium 300 mg should not be utilized for use in secondary prevention in patients with AVD." - Anonymous Online Contributor

Unverified Answer

What does inclisiran sodium 300 mg usually treat?

"The study showed that, regardless of the medication prescribed to patients who received inclisiran 300 mg daily, the decline in the cognitive function of patients with diabetic nephropathy is relatively stable. These patients with diabetic nephropathy can be treated with this medication with no significant additional risk. However, further work is needed to understand how inclisiran affects the decline of the cognitive function of patients with diabetic nephropathy, before initiating a clinical trial." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of inclisiran sodium 300 mg?

"The most common side effects are: hypertension, headache, nausea, and dizziness. Symptoms disappear after the drug is administered and if left untreated, they may occur again after the treatment is stopped. There have been no deaths as of yet during treatment." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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