A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis

Primary Outcome Measures

1. Change in peak aortic jet velocity
   To demonstrate the superiority of pelacarsen (TQJ230) vs. placebo in slowing the progression of calcific aortic valve stenosis by evaluating the change from baseline to month 36 in peak aortic jet velocity by echocardiography
2. Change in aortic valve calcium score
   To demonstrate the superiority of pelacarsen (TQJ230) vs. placebo in slowing the progression of calcific aortic valve stenosis by evaluating the change from baseline to month 36 in aortic valve calcium score by computed tomography

Secondary Outcome Measures

1. Change in Lp(a) levels
   To assess the effect of pelacarsen (TQJ230) vs. placebo on the reduction of Lp(a) levels from baseline to month 12
2. Change in fibrocalcific thickening of the aortic valve
   To assess the effect of pelacarsen (TQJ230) vs. placebo in slowing the progression of CAVS by evaluating the change from baseline to month 36 in fibrocalcific thickening of the aortic valve by contrast CT
3. Time from randomization to first occurrence of composite clinical endpoint event
   To assess the effect of pelacarsen (TQJ230) vs. placebo in reducing the risk of composite clinical endpoint defined as reaching either: 1. Unplanned CAVS related hospital admission 2. Aortic valve intervention 3. Death related to calcific aortic valve stenosis