Pelacarsen for Cardiovascular Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial focuses on providing ongoing access to a treatment called pelacarsen for individuals with cardiovascular disease. It aims to continue supporting participants who completed earlier studies with pelacarsen, a medication for managing cardiovascular conditions. Suitable candidates include those who finished the previous studies without major issues or treatment discontinuation. As a Phase 3 trial, this is the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new treatment.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Is there any evidence suggesting that pelacarsen is likely to be safe for humans?
Research has shown that pelacarsen is generally safe for people. One study found pelacarsen to be safe and well-tolerated, even in participants with mild liver problems. Most side effects were mild, and no serious health issues were directly linked to the treatment. Another study demonstrated that pelacarsen effectively lowered lipoprotein(a) levels, a risk factor for heart disease, without causing major safety concerns. These findings suggest that pelacarsen is a promising treatment with a good safety record.12345
Why do researchers think this study treatment might be promising?
Pelacarsen is unique because it targets lipoprotein(a), a specific type of cholesterol particle that has been linked to cardiovascular disease, which is not directly addressed by current treatments like statins or PCSK9 inhibitors. Unlike these standard treatments that primarily focus on lowering LDL cholesterol, Pelacarsen works by reducing the levels of lipoprotein(a) in the blood, potentially offering a new avenue for patients who have high levels of this particle and are at risk for cardiovascular events. Researchers are excited about Pelacarsen because it could fill a gap in cardiovascular care, providing a targeted treatment option for those with elevated lipoprotein(a) who may not benefit fully from existing therapies.
What evidence suggests that pelacarsen might be an effective treatment for cardiovascular disease?
Research has shown that pelacarsen, the investigational treatment in this trial, can lower lipoprotein(a) levels, which is linked to a reduced risk of heart disease. In one study, pelacarsen significantly lowered lipoprotein(a) levels, with 98% of patients reaching safer levels for heart health. This reduction helps prevent heart problems like coronary heart disease. Another study confirmed that pelacarsen reduces heart risks compared to a placebo. These findings suggest that pelacarsen could help lower heart-related issues for people with high lipoprotein(a) levels.23678
Are You a Good Fit for This Trial?
This trial is for individuals who have completed a previous pelacarsen study and received treatment until the end. They must consent to continue in this extension program, which provides ongoing access to pelacarsen.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Open-label Extension
Participants receive open-label pelacarsen 80 mg once a month
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Pelacarsen
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD