Inclisiran for Cardiovascular Diseases
This study is evaluating whether a new drug can be used to treat high cholesterol.
See full descriptionAbout the trial for Cardiovascular Diseases
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.
About The Treatment
Side Effect Profile for Inclisiran
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.
Approximate Timelines
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.
Patient Q & A Section
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.