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A multicenter trial assessing the impact of lipoprotein(a) lowering with pelacarsen (TQJ230) on the rate of weekly lipoprotein apheresis sessions in patients with hyperlipoproteinemia(a) and established cardiovascular disease in Germany.
EU CTIS ID: 2023-508324-35-00
What this study is testing
Demonstrate superiority of pelacarsen (TQJ230) compared to placebo in reducing the rate of lipoprotein apheresis sessions in patients with hyperlipoproteinemia(a) and established CVD during 52 weeks of treatment
- Therapeutic confirmatory (Phase III)
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
- Patients currently undergoing lipoprotein apheresis for isolated Lp(a) on a weekly schedule in Germany for ≥ 12 months prior to screening with at least 35 sessions within the past 52 weeks prior to randomization
- Lipoprotein(a) (Lp(a))> 60 mg/dL at screening
- Spontaneous prior myocardial infarction (MI): ≥ 3 months prior to the screening visit, and/or Ischemic stroke: ≥ 3 months prior to the screening visit, and/or Clinically significant symptomatic peripheral artery disease (PAD) and/or Clinically significant symptomatic coronary artery disease (CAD)
You likely can't join if
- Uncontrolled hypertension
- Heart failure New York Heart Association (NYHA) class IV
- History of malignancy of any organ system
- History of hemorrhagic stroke or other major bleeding
- Platelet count <140,000 per mm3 at screening
- Active liver disease or hepatic dysfunction
See the full eligibility criteria
- Patients currently undergoing lipoprotein apheresis for isolated Lp(a) on a weekly schedule in Germany for ≥ 12 months prior to screening with at least 35 sessions within the past 52 weeks prior to randomization
- Lipoprotein(a) (Lp(a))> 60 mg/dL at screening
- Spontaneous prior myocardial infarction (MI): ≥ 3 months prior to the screening visit, and/or Ischemic stroke: ≥ 3 months prior to the screening visit, and/or Clinically significant symptomatic peripheral artery disease (PAD) and/or Clinically significant symptomatic coronary artery disease (CAD)
- Uncontrolled hypertension
- Heart failure New York Heart Association (NYHA) class IV
- History of malignancy of any organ system
- History of hemorrhagic stroke or other major bleeding
- Platelet count <140,000 per mm3 at screening
- Active liver disease or hepatic dysfunction
- Significant kidney disease
- Pregnant or nursing women
The study team makes the final eligibility decision.
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.
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.