BridgeMD
A multicenter trial assessing the impact of lipoprotein (a) lowering with pelacarsen (TQJ230) on major cardiovascular events in patients with cardiovascular disease
EU CTIS ID: 2023-508292-37-00
What this study is testing
The primary objectives of this study is to demonstrate the superiority of pelacarsen (TQJ230) compared to placebo in reducing the risk of expanded MACE (cardiovascular death, non-fatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in 1) the overall study population with established CVD (Lp(a) ≥ 70 mg/dL) and/or 2) in a subpopulation with established CVD and Lp(a) ≥ 90 mg/dL.
- 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
- Lp(a) ≥ 70 mg/dL at the screening visit
- Optimal LDL-cholesterol lowering treatment
- Myocardial infarction: ≥ 3 months from screening and randomization visits to ≤ 10 years prior to the screening visit, and/or
- Ischemic stroke: ≥ 3 months from screening and randomization visits to ≤ 10 years prior to the screening visit, and/or
- Clinically significant symptomatic peripheral artery disease
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
- Active liver disease or hepatic dysfunction
See the full eligibility criteria
- Lp(a) ≥ 70 mg/dL at the screening visit
- Optimal LDL-cholesterol lowering treatment
- Myocardial infarction: ≥ 3 months from screening and randomization visits to ≤ 10 years prior to the screening visit, and/or
- Ischemic stroke: ≥ 3 months from screening and randomization visits to ≤ 10 years prior to the screening visit, and/or
- Clinically significant symptomatic peripheral artery disease
- 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
- Active liver disease or hepatic dysfunction
- Significant kidney disease
- Pregnant or nursing women
The study team makes the final eligibility decision.
Where it's taking place
- Russian Federation
- Peru
- Turkey
- China
- Switzerland
- Australia
- India
- United States
- Brazil
- Japan
- Guatemala
- Israel
- Taiwan
- South Africa
- United Kingdom
- Colombia
- Mexico
- Argentina
- Chile
- Hong Kong
+ 2 more site(s).
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Russian Federation; Peru; Turkey; China; Switzerland; Australia and 16 more location(s). 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.