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A randomized double-blind, placebo-controlled, multicenter trial assessing the impact of lipoprotein(a) lowering with pelacarsen (TQJ230) on the progression of calcific aortic valve stenosis [Lp(a)FRONTIERS CAVS]
EU CTIS ID: 2022-502135-19-00
What this study is testing
To demonstrate the superiority of pelacarsen (TQJ230) versus placebo in slowing the progression of calcific aortic valve stenosis by evaluating the change from baseline to month 36 in peak aortic jet velocity by echocardiography and, To demonstrate the superiority of pelacarsen (TQJ230) vs. placebo in slowing the progression of calcific aortic valve stenosis by evaluating the change from baseline to month 36 in aortic valve calcium score by computed tomography
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male and female ≥50 to <80 years of age
- Lipoprotein(a) ≥175 nmol/L, measured at the central laboratory
- Mild or moderate calcific aortic valve stenosis, as assessed by the core laboratory
- At the randomization visit, participant must be optimally treated for existing CV risk factors
You likely can't join if
- Severe calcific aortic valve stenosis as assessed by the core laboratory
- History of hemorrhagic stroke or other major bleeding
- Platelet count <140,000 per mm3
- Active liver disease or hepatic dysfunction
- Significant kidney disease
- Pregnant or nursing women
See the full eligibility criteria
- Male and female ≥50 to <80 years of age
- Lipoprotein(a) ≥175 nmol/L, measured at the central laboratory
- Mild or moderate calcific aortic valve stenosis, as assessed by the core laboratory
- At the randomization visit, participant must be optimally treated for existing CV risk factors
- Severe calcific aortic valve stenosis as assessed by the core laboratory
- History of hemorrhagic stroke or other major bleeding
- Platelet count <140,000 per mm3
- Active liver disease or hepatic dysfunction
- Significant kidney disease
- Pregnant or nursing women
- Uncontrolled hypertension
- History of malignancy of any organ system
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Israel
- United Kingdom
- Canada
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Israel; United Kingdom; Canada; Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.