A randomized double-blind, placebo-controlled, multicenter trial assessing the impact of lipoprotein (a) lowering with pelacarsen (TQJ230) on major cardiovascular events in patients with established cardiovascular disease

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508292-37-00

Acronym

CTQJ230A12301

Enrollment

4117

Registered

2024-05-03

Start date

2020-03-06

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease

Brief summary

Time to the first occurrence of CEC confirmed expanded MACE (cardiovascular death, nonfatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in a population of patients with elevated Lp(a) ≥ 70 mg/dL, Time to the first occurrence of CEC confirmed expanded MACE (cardiovascular death, non-fatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in a subpopulation of patients with elevated Lp(a) ≥ 90 mg/dL

Detailed description

Time to the first occurrence of the CEC confirmed composite endpoint of MACE (CV death, non-fatal MI, and non-fatal stroke), Time to the first occurrence of the CEC confirmed composite endpoint of CHD: CHD death, non-fatal MI, urgent coronary revascularization requiring hospitalization, Change in Lp(a) in the log scale from baseline at 1 year, Time to CEC confirmed all-cause death

Interventions

DRUGTQJ230

DRUGPlacebo to TQJ230 80 mg/0.8 mL Solution for injection in pre-filled syringe with needle safety device

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Time to the first occurrence of CEC confirmed expanded MACE (cardiovascular death, nonfatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in a population of patients with elevated Lp(a) ≥ 70 mg/dL, Time to the first occurrence of CEC confirmed expanded MACE (cardiovascular death, non-fatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in a subpopulation of patients with elevated Lp(a) ≥ 90 mg/dL	—

Measure

Time frame

—

Secondary

Measure	Time frame
Time to the first occurrence of the CEC confirmed composite endpoint of MACE (CV death, non-fatal MI, and non-fatal stroke), Time to the first occurrence of the CEC confirmed composite endpoint of CHD: CHD death, non-fatal MI, urgent coronary revascularization requiring hospitalization, Change in Lp(a) in the log scale from baseline at 1 year, Time to CEC confirmed all-cause death	—

Countries

Austria, Belgium, Bulgaria, Czechia, Denmark, France, Germany, Greece, Hungary, Iceland, Italy, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026