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]

Phase 2

Recruiting

• Conditions: Calcific Aortic Valve Stenosis

• Registration Number: 2022-502135-19-00
• Lead Sponsor: Novartis Pharma AG

Brief Summary

To demonstrate the superiority of pelacarsen (TQJ230) versus 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 and,

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-02
• Study First Submitted QC: 2022-12-02
• Study First Posted: 2022-12-12
• Study Start: 2024-03-07
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-15
• Last Update Posted: 2025-10-20
• Primary Completion: 2030-03-12
• Study Completion: 2030-03-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 264

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in peak aortic jet velocity from baseline to month 36		Change in peak aortic jet velocity from baseline to month 36
Change in aortic valve calcium score from baseline to month 36		Change in aortic valve calcium score from baseline to month 36

Secondary Outcome Measures

Name	Time	Method
Change in lipoprotein(a) levels from baseline to month 12		Change in lipoprotein(a) levels from baseline to month 12
Change in fibrocalcific thickening of the aortic valve from baseline to month 36		Change in fibrocalcific thickening of the aortic valve from baseline to month 36
Time from randomization to first occurrence of composite clinical endpoint event, defined as reaching either: • Unplanned CAVS related hospital admission • Aortic valve intervention • Death related to calcific aortic valve stenosis		Time from randomization to first occurrence of composite clinical endpoint event, defined as reaching either: • Unplanned CAVS related hospital admission • Aortic valve intervention • Death related to calcific aortic valve stenosis
Safety endpoints (including adverse events/serious adverse events, safety laboratory parameters, vital signs) collected from baseline to end of study		Safety endpoints (including adverse events/serious adverse events, safety laboratory parameters, vital signs) collected from baseline to end of study

Trial Locations

Locations (33)

Nova Clinical Research LLC; 🇺🇸 Bradenton, Florida, United States

Heart Center Research Llc; 🇺🇸 Huntsville, Alabama, United States

Cardiovascular Res Found; 🇺🇸 Beverly Hills, California, United States

National Heart Institute; 🇺🇸 Beverly Hills, California, United States

Foothill Cardiology; 🇺🇸 Covina, California, United States

Valley Clinical Trials; 🇺🇸 Northridge, California, United States

Stanford University Medical Center; 🇺🇸 Palo Alto, California, United States

University Of California San Diego; 🇺🇸 San Diego, California, United States

UC San Francisco Medical Center; 🇺🇸 San Francisco, California, United States

Excel Medical Clinical Trials LLC; 🇺🇸 Boca Raton, Florida, United States

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