Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD
Purpose
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)
Condition
- Cardiovascular Disease and Lipoprotein(a)
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
- 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 Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental TQJ230 |
TQJ230 80 mg injected monthly administered subcutaneously |
|
|
Placebo Comparator Placebo |
Monthly subcutaneous injections. |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- Novartis Pharmaceuticals