A multicenter trial assessing the impact of lipoprotein (a) lowering with pelacarsen (TQJ230) on major cardiovascular events in patients with cardiovascular disease
- Conditions
- Cardiovascular DiseaseMedDRA version: 21.1Level: LLTClassification code: 10051614Term: Arteriosclerotic cardiovascular disease Class: 10047065Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2023-508292-37-00
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 8323
Lp(a) = 70 mg/dL at the screening visit, Optimal LDL-cholesterol lowering treatment, Optimal treatment of other CV risk factors, Myocardial infarction: = 3 months from screening and randomization visits to = 10 years prior to the screening visit, and/or, Ischemic stroke: = 3 months from screening and randomization visits to = 10 years prior to the screening visit, and/or, Clinically significant symptomatic peripheral artery disease
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 <140,000 per mm3, Active liver disease or hepatic dysfunction, Significant kidney disease, Pregnant or nursing women
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method