A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis
- Conditions
- Aortic Stenosis
- Interventions
- Drug: Matching placebo
- Registration Number
- NCT05646381
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 502
- 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
- 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
- Arm && Interventions
Group Intervention Description Pelacarsen (TQJ230) 80mg Pelacarsen (TQJ230) 80mg Pelacarsen (TQJ230) 80 mg prefilled syringe injected monthly, administered subcutaneously Matching placebo Matching placebo Placebo to match pelacarsen (TQJ230) prefilled syringe injected monthly, administered subcutaneously
- Primary Outcome Measures
Name Time Method Change in peak aortic jet velocity 36 months 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
Change in aortic valve calcium score 36 months 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
Name Time Method Change in Lp(a) levels 12 months To assess the effect of pelacarsen (TQJ230) vs. placebo on the reduction of Lp(a) levels from baseline to month 12
Change in fibrocalcific thickening of the aortic valve 36 months 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 from randomization to first occurrence of composite clinical endpoint event Up to 36 months 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
Trial Locations
- Locations (29)
Heart Center Research Llc
🇺🇸Huntsville, Alabama, United States
Cardiovascular Res Found
🇺🇸Beverly Hills, California, United States
National Heart Institute
🇺🇸Beverly Hills, California, United States
Valley Clinical Trials
🇺🇸Northridge, California, United States
University Of California San Diego
🇺🇸San Diego, California, United States
UC San Francisco Medical Center
🇺🇸San Francisco, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Excel Medical Clinical Trials LLC
🇺🇸Boca Raton, Florida, United States
Inpatient Research Clinical LLC
🇺🇸Miami Lakes, Florida, United States
Advanced Research for Health Improvement LLC
🇺🇸Naples, Florida, United States
Midwest Heart and Vascular Spec
🇺🇸Overland Park, Kansas, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Brigham and Womens Hosp Harvard Med School
🇺🇸Boston, Massachusetts, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Minneapolis Heart Institute
🇺🇸Minneapolis, Minnesota, United States
University Of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Overlook Medical Center
🇺🇸Summit, New Jersey, United States
New York Presbyterian Hospital
🇺🇸New York, New York, United States
Icahn School of Med at Mt Sinai
🇺🇸New York, New York, United States
Strong Memorial Hospital
🇺🇸Rochester, New York, United States
Wake Forest University Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Carl and Edyth Lindner Ctr for Resch and Ed at The Christ Hosp
🇺🇸Cincinnati, Ohio, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Perelman School of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Virginia Heart
🇺🇸Falls Church, Virginia, United States
Carient Heart and Vascular
🇺🇸Manassas, Virginia, United States
Novartis Investigative Site
🇬🇧Tyne And Wear, United Kingdom