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]

Phase 1

Recruiting

• Conditions: Calcific Aortic Valve Stenosis; MedDRA version: 20.0Level: SOCClassification code: 10007541Term: Cardiac disorders Class: 11; MedDRA version: 20.0Level: PTClassification code: 10002918Term: Aortic valve stenosis Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2022-502135-19-00
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-02
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 502

Inclusion Criteria

Male and female =50 to <80 years of age, Lipoprotein(a) =175 nmol/L at Screening-Part I, measured at the central laboratory, Mild or moderate calcific aortic valve stenosis as defined by a peak aortic jet velocity =2.5 m/s and =3.5 m/s at Screening-Part II, as assessed by the core laboratory, At the randomization visit, participant must be optimally treated for existing CV risk factors (e.g. LDL-C, Diabetes Mellitus and hypertension according to local practice/guidelines)

Exclusion Criteria

Severe calcific aortic valve stenosis defined by mean gradient >40 mmHg or aortic valve area <1 cm2 at Screening-Part II, 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, Planned aortic valve intervention, Unicuspid valve or other congenital cardiac anomaly (bicuspid aortic valve morphology is not excluded), at Screening-Part II, as assessed by the core laboratory, Severe mitral valve stenosis (valve area <1.5 cm2), severe mitral valve regurgitation, or severe aortic valve regurgitation at Screening-Part II, as assessed by the core laboratory, Inability to undergo or to acquire an optimal echocardiogram or computed tomography, or contraindication to computed tomography contrast media, Left ventricular ejection fraction <55% at Screening-Part II, as assessed by the core laboratory, Heart failure New York Heart Association class III - IV at Screening-Part II or at Randomization visit (Day 1), Uncontrolled hypertension, History of malignancy of any organ system

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified