Status:
RECRUITING
A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Aortic Stenosis
Eligibility:
All Genders
50-80 years
Phase:
PHASE2
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 calcifi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 12 2030
Estimated Enrollment :
502 Patients enrolled
Trial Details
Trial ID
NCT05646381
Start Date
March 7 2024
End Date
March 12 2030
Last Update
February 9 2026
Active Locations (136)
Enter a location and click search to find clinical trials sorted by distance.
1
Heart Center Research Llc
Huntsville, Alabama, United States, 35801
2
Cardiovascular Res Found
Beverly Hills, California, United States, 90210
3
National Heart Institute
Beverly Hills, California, United States, 90211
4
Flourish Clinical Resrch Covin
Covina, California, United States, 91723