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

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]

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05646381
• Other study ID #: CTQJ230A12203
• Status: Recruiting
• Phase: Phase 2
• Start date: March 7, 2024
• Est. completion date: January 3, 2029

Study information

• Verified date: April 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: 1-888-669-6682
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Drug:
• Pelacarsen (TQJ230) 80mg
Pelacarsen (TQJ230) 80mg
• Matching placebo
Matching placebo

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  Israel,  United Kingdom, 

Outcome

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