CLINICAL TRIAL

Inclisiran for Cardiovascular Diseases

Recruiting · 18+ · All Sexes · Greenwich, CT

This study is evaluating whether a new drug can be used to treat high cholesterol.

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About the trial for Cardiovascular Diseases

Eligible Conditions
Atherosclerotic Cardiovascular Diseases · Cardiovascular Diseases · Atherosclerosis

Treatment Groups

This trial involves 2 different treatments. Inclisiran is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Inclisiran
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inclisiran
FDA approved

Side Effect Profile for Inclisiran

Inclisiran
Show all side effects
Nasopharyngitis
12%
Injection site reaction
9%
Back pain
7%
Upper respiratory tract infection
7%
Influenza
5%
Acute myocardial infarction
1%
Aortic valve stenosis
1%
Cellulitis
0%
Supraventricular tachycardia
0%
Pancreatitis acute
0%
Post procedural haematuria
0%
Asthma
0%
Cardiac failure
0%
Optic ischaemic neuropathy
0%
Myocardial infarction
0%
Non-cardiac chest pain
0%
Malignant melanoma in situ
0%
Biliary colic
0%
Soft tissue injury
0%
Hernia
0%
Invasive ductal breast carcinoma
0%
Viral upper respiratory tract infection
0%
Cardiac failure acute
0%
Coronary artery disease
0%
Arteriosclerosis coronary artery
0%
Tick-borne fever
0%
Wound sepsis
0%
Infective tenosynovitis
0%
Pneumonia
0%
Myalgia
0%
Squamous cell carcinoma of skin
0%
Hydronephrosis
0%
Prostate cancer
0%
Sensory disturbance
0%
Device loosening
0%
Depression
0%
Chronic obstructive pulmonary disease
0%
Angina unstable
0%
Cardiac arrest
0%
Gastritis erosive
0%
Road traffic accident
0%
Major depression
0%
Post procedural infection
0%
Trigeminal neuralgia
0%
Nephrolithiasis
0%
Myocardial ischaemia
0%
Diverticulitis
0%
Pyelitis
0%
Limb injury
0%
Anxiety
0%
Spinal compression fracture
0%
Angina Pectoris
0%
Pyelonephritis
0%
Atrial fibrillation
0%
This histogram enumerates side effects from a completed 2019 Phase 3 trial (NCT03397121) in the Inclisiran ARM group. Side effects include: Nasopharyngitis with 12%, Injection site reaction with 9%, Back pain with 7%, Upper respiratory tract infection with 7%, Influenza with 5%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Calculated glomerular filtration rate >30 mL/min by estimated glomerular filtration rate (eGFR) using standardized local clinical methodology
Participants should be on maximally tolerated statin therapy, as determined by the investigator, with no immediate plans to modify lipid lowering therapies. Statin intolerant patients are eligible if they had documented side effects on at least 2 different statins, including one at the lowest standard dose
Males and females ≥18 years of age
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Day 90 to Day 330
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Day 90 to Day 330.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Inclisiran will improve 2 primary outcomes and 17 secondary outcomes in patients with Cardiovascular Diseases. Measurement will happen over the course of Day 330.

Proportion of days covered (total number of days on either statin, ezetimibe, bempedoic acid or PCSK9 inhibiting monoclonal antibody therapies divided by total number of study days)
DAY 330
To assess adherence to background lipid-lowering therapy in participants receiving an "inclisiran first" implementation strategy compared to usual care at Day 330
Intensity of lipid lowering therapy (decrease in dose, no change in dose, increase in dose)
DAY 330
To assess changes in background lipid-lowering therapy in participants receiving an "inclisiran first" implementation strategy compared to usual care at Day 330
Percent change and absolute change from baseline in HDL-C
DAY 330
To assess HDL-C in participants receiving an "inclisiran first" implementation strategy compared to usual care at Day 330
Percent change and absolute change from baseline in Lp(a)
DAY 330
To assess Lp(a) in participants receiving an "inclisiran first" implementation strategy compared to usual care at Day 330
Percent change and absolute change from baseline in triglycerides
DAY 330
To assess triglycerides in participants receiving an "inclisiran first" implementation strategy compared to usual care at Day 330
Percent change and absolute change from baseline in total cholesterol
DAY 330
To assess total cholesterol in participants receiving an "inclisiran first" implementation strategy compared to usual care at Day 330
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Patient Q & A Section

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

What causes cardiovascular diseases?

In a general population of healthy young adults, the main causes of death from cardiovascular diseases are not related to specific diseases, but to age at which disease occurs. The rate of death from ischaemic heart disease is high in young women, but low in older women, men, and men aged 60 or more.

Anonymous Patient Answer

What is cardiovascular diseases?

[Cardiovascular diseases cause millions of deaths every year in the world, and it affects most people before they reach 55, mostly in developing countries, with emerging epidemic. Cardiovascular diseases are associated with coronary heart disease, which manifests as angina pectoris and heart attacks, as hypertension leading to heart failure, as a complication of diabetes mellitus, and as chronic kidney disease before dialysis begins, which is a progressive degenerative and incurable disease, and affects people of all ages, genders and countries. In conclusion, cardiovascular diseases are often the result of risk factors such as the use of tobacco products, overweight, and low physical activities or diet, in addition to other predisposing illnesses such as diabetes, hypertension, and dyslipidemia.

Anonymous Patient Answer

Can cardiovascular diseases be cured?

In patients with known and/or diagnosed coronary heart disease and a clinical history of recurrent vascular events, a cure for cardiovascular disease does not exist, as cardiovascular disease is the result of many separate events that have a cumulative effect.

Anonymous Patient Answer

What are the signs of cardiovascular diseases?

A careful medical history including that of a family member or a partner, symptoms of chest pain, syncope, peripheral edema or oedema, dyspnea on exertion, and palpitations, are the most helpful signs for the diagnosis of CAD among those without the clinical symptoms of chronic CAD.

Anonymous Patient Answer

What are common treatments for cardiovascular diseases?

For cardiovascular diseases, interventions may target specific risks. For hypertension, the goal is the prevention of future cardiovascular disease. For coronary heart disease, the goal may be to delay the development of heart failure in the patient. Other interventions may include the prevention of recurrent heart attacks. For stroke, the goal may be the prevention of future heart attacks or the prevention of dementia. Other interventions to reduce the risk of heart attacks or stroke and to prevent stroke are: dietary choices of the correct type and fat content, the reduction of unhealthy fats, physical exercise, and avoidance of smoking, and medication for cholesterol, hypertension, diabetes and other cardiovascular disease prevention.

Anonymous Patient Answer

How many people get cardiovascular diseases a year in the United States?

Approximately 2,300,000 Americans will be diagnosed with at least one of 5 CV diseases (cardiovascular diseases, cancer, cerebrovascular disorders, peripheral vascular diseases, and arrhythmia) in 2022. Of these 2,300,000, approximately 900,000 will be diagnosed with 2 or more CV diseases. For example, approximately 60% of those with cancer will also have a CV disease.

Anonymous Patient Answer

What is inclisiran?

Recent findings of this study suggested that the use of the oral administration of inclisiran as a new strategy to combat cardiovascular diseases by targeting endothelial dysfunction. Such a strategy may be advantageous over conventional strategies used today by targeting the synthesis of NO.

Anonymous Patient Answer

What is the latest research for cardiovascular diseases?

There are many advances in the treatment of cardiovascular diseases. Research is being conducted to explore new potential cardiovascular diseases treatments. Because of the limitations of current clinical trials, there are no cures for cardiovascular diseases within 10 years according to a recent research. Currently, there is only one therapeutic approach for cardiovascular diseases treatment, that is the [Vascular surgery for patients with arterial or Venous Surg]. There are two types of cardiovascular surgical procedures. There are a few type of cardiovascular diseases patients have that would require a surgical process. They are a heart attack, a stroke, or a combination of the two. Currently, there are no treatments are available for cardiovascular diseases with 5 years from a diagnosis.

Anonymous Patient Answer

What is the average age someone gets cardiovascular diseases?

For patients who are 70 years old or older, 1 out of 4 will have a history of at least one cardiovascular disease at the time of their visit.

Anonymous Patient Answer

Is inclisiran safe for people?

Inclisiran was generally well tolerated in the 3 trials of non-fatal CV events, with a number of CV events reported in the placebo arm. The only CV events occurring in a pattern statistically different from placebo were strokes and deaths during the safety analysis phase in the trial with long-term follow-up (n=536). There were no differences in CV death rates between the 2 phase IV trials; however, in both cases, the treatment arm had a trend towards lower CV odds than placebo. The safety profile for CV events was very similar between the CLARE and CLEVER trials, with a number of CV events reported in the placebo arm of all 3 trials at the conclusion of the CLEVER trial.

Anonymous Patient Answer

What are the latest developments in inclisiran for therapeutic use?

The first phase III trial demonstrated the strong anti-fibrotic effect of injisiran in patients that are either treatment-naive of have a failed response to traditional therapies. This effect is associated with reduced left ventricular mass, but is offset by symptomatic improvement (in heart failure patients) and increase or maintenance of QTc (in patients without prior QT-interval abnormalities) in both the safety and efficacy population. Results from a recent clinical trial have been sustained, over an extended period of time, in patients with end stage heart failure.

Anonymous Patient Answer

Have there been any new discoveries for treating cardiovascular diseases?

Although many studies had been conducted in different areas, the discovery of new compounds or therapeutic mechanisms to treat cardiovascular diseases was limited. The new compounds and mechanisms are expected to be discovered as the number of compounds that have therapeutic potential is increasing.

Anonymous Patient Answer
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