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Inclisiran for Cardiovascular Disease(VICTORION-2P Trial)
VICTORION-2P Trial Summary
This trial is testing a new drug to see if it can help prevent major heart problems in people who already have heart disease.
- Atherosclerotic Cardiovascular Disease
VICTORION-2P Trial Eligibility Criteria
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
VICTORION-2P Trial Timeline
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Awards & Highlights
VICTORION-2P Trial Design
Find a Location
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
- You have had a spontaneous myocardial infarction (heart attack) ≥ 4 weeks from the screening visit.Have you experienced a heart attack, stroke, or peripheral arterial disease?You have a serious health condition that is not related to your cardiovascular system and is likely to reduce your lifespan to less than 5 years.You are currently pregnant or breastfeeding.There may be additional requirements that you have to meet or factors that exclude you from participating in the study based on the specific details of the study.You had a stroke caused by a blocked blood vessel at least 4 weeks before the screening visit.You had a heart attack, stroke, or surgery to improve blood flow within the past four weeks.You have taken any drug that targets PCSK9, like inclisiran, within the last two years.You have taken or plan to take PCSK9 inhibitors (such as evolocumab or alirocumab) within 90 days after your first study visit.You have severe heart failure, classified as NYHA class III or IV.Answer yes if you are not currently taking or planning to take PCSK9 inhibitors. These are medications like Repatha (Evolocumab) and Praluent (Alirocumab).Are you current on lipid-lowering regimen that includes medications like statins?
- Group 1: Inclisiran sodium
- Group 2: Placebo
- 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: You will receive the treatment for 36 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 0 Months after you stop receiving the treatment.
Frequently Asked Questions
Can you tell me how many different hospitals are participating in this research project?
"There are 100 sites running this trial, such as Meridian Clinical Research in Crowley, Samaritan Cardiology in Munster, and Inpatient Research Clinical LLC in Eunice."
Has Inclisiran sodium 300 mg been cleared by the FDA?
"Inclisiran sodium 300 mg is in Phase 3 of clinical trials. This means that there is some data to support its efficacy and multiple rounds of data supporting safety, so our team at Power gave it a score of 3 for safety."
What are some common reasons why doctors prescribe Inclisiran sodium 300 mg?
"Inclisiran sodium 300mg can be used as a treatment for primary hypercholesterolemia, hypercholesterolemia, and diet."
Have there been any other similar studies to this one in the past?
"Inclisiran sodium 300 mg has been under scientific observation since 2018. After the first clinical trial, which was sponsored by Novartis Pharmaceuticals and conducted in 2018 with 15000 participants, Inclisiran sodium 300 mg received Phase 3 drug approval. There are currently 11 active studies involving Inclisiran sodium 300 mg spanning 588 cities and 52 countries."
What is the patient quota for this experiment?
"In order for this trial to move forward, 15000 volunteers that fit the pre-determined inclusion criteria must participate. Those interested can sign up at Meridian Clinical Research in Crowley, Louisiana and Samaritan Cardiology, Louisiana and Samaritan Cardiology in Munster, Indiana."
Is this research project still looking for volunteers?
"Yes, this trial is still recruiting patients according to the information available on clinicaltrials.gov. This particular study was posted on 11/23/2021 and edited as recently as 9/28/2022."
Are there other research studies that have used Inclisiran sodium 300 mg?
"There are 11 different ongoing clinical trials looking into the effects of Inclisiran sodium 300 mg. The majority of these studies are in Phase 3 and originate from Mexico City. However, there are a total of 1414 trial locations for Inclisiran sodium 300 mg around the world."
Who else is applying?
What state do they live in?
How old are they?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
What site did they apply to?
Why did patients apply to this trial?
What questions have other patients asked about this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Accellacare Research Site (37938): < 48 hours
- Novartis Investigative Site: < 48 hours
Average response time
- < 2 Days
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