Olpasiran for Cardiovascular Disease
(OCEAN(a)-CCTA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called olpasiran to determine if it can reduce the buildup of non-calcified plaque in the arteries of people with heart disease. The researchers aim to compare the effects of olpasiran, administered as an injection every 12 weeks, with a placebo (a non-active substance). Suitable candidates for this trial have heart disease, high levels of Lp(a) (a specific type of cholesterol), and a history of heart attacks or certain heart procedures. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
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 trial coordinators or your doctor.
Is there any evidence suggesting that olpasiran is likely to be safe for humans?
Research has shown that olpasiran is generally safe and well-tolerated. Studies have found that side effects are uncommon, and most participants did not experience serious problems while taking the treatment. In earlier studies, researchers tested the drug on individuals with heart issues and successfully lowered lipoprotein(a), a type of cholesterol linked to heart disease.
Reports indicate that even higher doses of olpasiran did not cause serious side effects. Ongoing research will provide more information, but current evidence suggests it is a promising option for those with heart concerns.12345Why do researchers think this study treatment might be promising?
Olpasiran is unique because it targets lipoprotein(a), a specific type of cholesterol linked to cardiovascular disease, which current treatments usually overlook. Most available therapies, like statins, primarily focus on lowering LDL cholesterol, but they don't effectively address high levels of lipoprotein(a). Researchers are excited about olpasiran because it offers a new mechanism of action by potentially reducing this specific cholesterol component, providing an innovative option for patients at risk of heart disease. Additionally, olpasiran is administered subcutaneously once every 12 weeks, offering a convenient dosing schedule compared to daily oral medications.
What evidence suggests that olpasiran might be an effective treatment for cardiovascular disease?
Research has shown that olpasiran, which participants in this trial may receive, can significantly lower lipoprotein(a) levels, a type of cholesterol linked to heart disease. In studies, olpasiran reduced lipoprotein(a) by over 95% in people with heart conditions and also decreased other harmful cholesterol types, such as LDL, often called "bad cholesterol." Even after stopping the treatment, patients who took olpasiran experienced a 40% to 50% reduction in lipoprotein(a). These findings suggest that olpasiran could help manage heart conditions by targeting specific cholesterol types.14567
Who Is on the Research Team?
MD
Principal Investigator
Amgen
Are You a Good Fit for This Trial?
This trial is for adults aged 35 to 80 who have high levels of lipoprotein(a), a history of heart attack or certain heart procedures, and signs of coronary artery disease on a special heart scan.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive olpasiran or placebo subcutaneously every 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Olpasiran
Trial Overview
The study compares olpasiran, an experimental drug that lowers lipoprotein(a), with a placebo. Participants are randomly assigned to receive either the drug or placebo, and changes in artery plaque are measured using CT scans.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive olpasiran subcutaneously (SC) once every 12 weeks (Q12W).
Participants will receive placebo SC Q12W.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Amgen
Lead Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London
Citations
Small Interfering RNA to Reduce Lipoprotein(a) in ...
Olpasiran therapy significantly reduced lipoprotein(a) concentrations in patients with established atherosclerotic cardiovascular disease.
Lowering of Lipoprotein(a) with Olpasiran
A phase 3 outcomes trial is currently underway. In this review article, we delve further into lowering of Lp(a) with Olpasiran by detailing its ...
An RNA Inhibitor Effectively Reduces a High-Risk Type of ...
The study reported that higher doses of olpasiran lowered the type of cholesterol called lipoprotein(a) [Lp(a)] by more than 95 percent in ...
Olpasiran Trials of Cardiovascular Events and Lipoprotein ...
The primary objective of this trial is to compare the effect of treatment with olpasiran, to placebo, on the risk for coronary heart disease death (CHD ...
Abstract 4348302: Olpasiran Outperforms Other ...
Conclusions: Among Lp(a)-targeted therapies, olpasiran showed the largest Lp(a), LDL-C, ApoB, and ACM lowering effects, ranking better than ...
The Off-Treatment Effects of Olpasiran on Lipoprotein(a) ...
Participants receiving doses ≥75 mg Q12W sustained a ∼40% to 50% reduction in Lp(a) levels close to 1 year after the last dose. (Olpasiran ...
Olpasiran Trials of Cardiovascular Events and Lipoprotein ...
The primary objective of this trial is to compare the effect of treatment with olpasiran, to placebo, on the risk for coronary heart disease death (CHD ...
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