Study CTQJ230A12203 is a phase 2 clinical trial which aims to evaluate if treatment with pelacarsen (TQJ230) versus placebo slows the progression of mild or moderate calcific aortic valve stenosis, and to further characterize the safety profile of the drug.
A multicenter trial assessing the impact of lipoprotein(a) lowering with pelacarsen (TQJ230) on the progression of calcific aortic valve stenosis
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] Clinical
Aortic stenosis
All genders
50+
Recruiting now
Overview
Principal Investigator: Benjamin S. Wessler
Contact Us
Juan Carlos Collado Falcon / Jamie Rubinstein
Study details
Inclusion Criteria
- 1. Signed informed consent must be obtained prior to participation in the study
- 2. Male and female ≥50 years of age
- 3. Lp(a) ≥125 nmol/L at Screening-Part I, measured at the central laboratory
Exclusion Criteria
- 1. Severe CAVS defined by mean gradient >40 mmHg or AVA <1 cm2 at Screening-Part II,
as assessed by the core laboratory - 2. Planned AVI
- 3. Unicuspid valve or other congenital cardiac anomaly as assessed at Screening-Part II, as
assessed by the core laboratory
Study Requirements
The purpose of this study is to evaluate the efficacy and safety of pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo (TQJ230) in slowing the progression of calcific aortic valve stenosis. -The double-blind study duration will be 36 months -The treatment duration will be 36 months -The visit frequency will be once monthly during the first 6 months then followed by every 3 months until the end of month 36 (completion of the study). Blood samples will be collected at several time-points throughout the study for assessment of hematology, clinical chemistry, lipids, among others. Echocardiography will be used to measure the change in peak aortic jet velocity measured at baseline, month 12, month 24, and month 36. CT will measure the change in AVC score from baseline to month 36, while contrast CT will be used to determine the change in fibrocalcific thickening of the aortic valve from baseline to month 36.