Status:
ACTIVE_NOT_RECRUITING
Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Cardiovascular Disease and Lipoprotein(a)
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
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)
Eligibility Criteria
Inclusion
- 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
- 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.
Exclusion
Key Trial Info
Start Date :
December 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2026
Estimated Enrollment :
8323 Patients enrolled
Trial Details
Trial ID
NCT04023552
Start Date
December 12 2019
End Date
February 26 2026
Last Update
December 31 2025
Active Locations (905)
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1
SEC Clinical Research LLC
Andalusia, Alabama, United States, 36420
2
Grandview Med Group Research LLC
Birmingham, Alabama, United States, 35243
3
Novartis Investigative Site
Birmingham, Alabama, United States, 35243
4
Heart Center Research Llc
Huntsville, Alabama, United States, 35801