Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD
About the study
This is a pivotal phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a)
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Key Inclusion Criteria
- Lp(a) ≥ 70 mg/dL at the screening visit, measured at the Central laboratory
- Myocardial infarction: ≥ 3 months from screening and randomization to ≤ 10 years prior to the screening visit
- Ischemic stroke: ≥ 3 months from screening and randomization to ≤ 10 years prior to the screening visit
- Clinically significant symptomatic peripheral artery disease
EXCLUSION CRITERIA
Key Exclusion Criteria
- Uncontrolled hypertension
- Heart failure New York Heart Association (NYHA) class IV
- 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 at the end.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Cardiovascular Disease and Lipoprotein(a)
Age (in years)
18 - 80
Phase
Phase 3
Participants needed
8323
Est. Completion Date
May 30, 2025
Treatment type
Interventional
Sponsor
Novartis
ClinicalTrials.gov identifier
NCT04023552
Study number
CTQJ230A12301
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