Aortic Stenosis Clinical Trial
Official title:
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]
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.
Status | Recruiting |
Enrollment | 502 |
Est. completion date | January 3, 2029 |
Est. primary completion date | January 3, 2029 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 80 Years |
Eligibility | Inclusion Criteria: - Male and female =50 to <80 years of age - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Novartis Investigative Site | Sainte Foy | Quebec |
Israel | Novartis Investigative Site | Beer-Sheva | |
Israel | Novartis Investigative Site | Haifa | |
Israel | Novartis Investigative Site | Jerusalem | |
Israel | Novartis Investigative Site | Nahariya | |
United Kingdom | Novartis Investigative Site | Tyne And Wear | |
United States | Excel Medical Clinical Trials LLC | Boca Raton | Florida |
United States | Carient Heart and Vascular | Manassas | Virginia |
United States | Advanced Research for Health Improvement LLC | Naples | Florida |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States, Canada, Israel, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 36 months | |
Primary | 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 | 36 months | |
Secondary | 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 | 12 months | |
Secondary | 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 | 36 months | |
Secondary | 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: Unplanned CAVS related hospital admission Aortic valve intervention Death related to calcific aortic valve stenosis |
Up to 36 months |
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