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]
Sponsor: Novartis Pharmaceuticals
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Change in peak aortic jet velocity
Time frame: 36 months
Change in aortic valve calcium score
Time frame: 36 months
Secondary Endpoints
Change in Lp(a) levels
Change in fibrocalcific thickening of the aortic valve
Time from randomization to first occurrence of composite clinical endpoint event
Eligibility Criteria
Inclusion Criteria: * Male and female ≥50 to \<80 years of age at Screening Part II * Lp(a) ≥175 nmol/L at the screening visit, measured at the Central laboratory * Mild or moderate calcific aortic valve stenosis * At the randomization visit, participant must be optimally treated for existing CV risk factors Exclusion Criteria: * Severe calcific aortic valve stenosis * Uncontrolled hypertension * History of malignancy of any organ system * History of hemorrhagic stroke or other major bleeding * Platelet count ≤ LLN * Active liver disease or hepatic dysfunction * Significant kidney disease * Pregnant or nursing women Other protocol-defined inclusion/exclusion criteria may apply
✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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