The purpose of this study is to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo in slowing the progression of calcific aortic valve stenosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
502
Pelacarsen (TQJ230) 80mg
Matching placebo
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
Time frame: 36 months
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
Time frame: 36 months
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
Time frame: 12 months
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
Time frame: 36 months
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
Time frame: Up to 36 months
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Heart Center Research Llc
Huntsville, Alabama, United States
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