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Inclisiran for Cardiovascular Disease (V-INITIATE Trial)
V-INITIATE Trial Summary
This trial is testing if adding inclisiran to statin therapy right away, instead of the usual care, is more effective in treating ASCVD.
- Atherosclerotic Cardiovascular Disease
V-INITIATE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 3 trial • 482 Patients • NCT03397121V-INITIATE Trial Design
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Who is running the clinical trial?
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- You have had a bad reaction or allergy to any of the study treatments or their ingredients, or to similar drugs in the past.You have a history of heavy alcohol or drug abuse within the past 5 years. However, if you only use drugs occasionally and not in a problematic way, you are still eligible to participate.You have experienced a serious heart rhythm problem within the past 3 months that is not controlled by medication or treatment.You have a serious illness that is not related to the heart and may shorten your life expectancy to less than 2 years.You had cancer and needed surgery, radiation therapy, or medication for it within the past two years.
- Group 1: Inclisiran First
- Group 2: Usual Care
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are we enrolling patients at this time for this research?
"That is correct, the online information does show that this clinical trial is still looking for participants. The first posting was on June 25th 2021 and there have been subsequent updates to the page, with the latest one being on October 17th 2022. In total, they are trying to get 444 people involved at 40 different hospitals or clinics."
What other research has been conducted on Inclisiran?
"Out of the 11 ongoing studies investigating Inclisiran, 10 are currently in Phase 3. Most of these live clinical trials are being conducted in Ciudad de Mexico, but Inclisiran is also being studied at 1414 other locations around the world."
When might Inclisiran be cleared for public use by the FDA?
"Inclisiran is considered safe according to our team's 3-point scale. This is due to the fact that Phase 3 trials have provided some data affirming the drug's efficacy as well as multiple rounds of data supporting its safety."
Is this the initial research project of its sort?
"There have been 11 clinical trials for Inclisiran since 2018, with the most recent one concluding earlier this year. These studies took place in 588 cities and 52 countries across the globe. The first study, sponsored by Novartis Pharmaceuticals, completed its Phase 3 drug approval stage in 2018."
What is Inclisiran's most common therapeutic target?
"While primary hypercholesterolemia is the most common reason to use Inclisiran, this medication can also help patients with diet-controlled hypercholesterolemia and atherosclerotic cardiovascular diseases."
How many subjects are enrolled in this trial?
"That is right, the clinicaltrials.gov website has information which says that this research project is looking for more participants. The first posting was on 6/25/2021 and there have been updates as recently as 10/17/2022. So far, 444 people have signed up across 40 different locations."
Are there different research facilities that are testing this in the United States?
"Presently, this clinical trial is being conducted at 40 different sites. The locations are situated in Marshfield, Weston and Hershey as well as other cities. If you elect to participate in this research study, it would be advantageous to select the clinic nearest your location to reduce travel requirements."
What are the goals that researchers are hoping to achieve with this clinical trial?
"The primary objective of this trial, which will be measured over a period of 330 days, is the change in LDL cholesterol levels from baseline. Additionally, this trial will also measure secondary outcomes including changes in VLDL cholesterol and apoB levels, as well as the intensity of lipid-lowering therapy (i.e. whether the dose is increased, decreased, or remains unchanged) over the same time period."
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