RECRUITINGPhase 2INTERVENTIONAL
A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis
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]
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Pelacarsen (TQJ230) 80mg
Pelacarsen (TQJ230) 80mg
DRUG
Matching placebo
Matching placebo
Locations (20)
Heart Center Research Llc
Huntsville, Alabama, United States
Cardiovascular Res Found
Beverly Hills, California, United States
National Heart Institute
Beverly Hills, California, United States
Flourish Clinical Resrch Covin
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
Nova Clinical Research LLC
Bradenton, Florida, United States
Flourish Res Acq LLC North Miami
Miami, 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
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Womens Hosp Harvard Med School
Boston, Massachusetts, United States
Brigham and Womens Hosp Harvard Med School
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States