A randomized double-blind, placebo-controlled, multicenter trial assessing the impact of lipoprotein (a) lowering with pelacarsen (TQJ230) on major cardiovascular events in patients with established cardiovascular disease (CVD).
- Conditions
- Major Adverse Cardiovascular Events (MACE)1008220610003216increased lipoprotein(a)
- Registration Number
- NL-OMON56054
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 410
- 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 to <= 10 years prior to the screening visit
and randomization visit
- Ischemic stroke: >= 3 months to <= 10 years prior to the screening visit and
randomization visit
- Clinically significant symptomatic peripheral artery disease
1) Uncontrolled hypertension
2) Treatment with a PCSK9 inhibitor within 12 weeks before randomization
3) Treatment with lipoprotein apheresis
4) Myocardial infarction, stroke, coronary or lower limb re-vascularization,
major cardiac or non-cardiac surgery within 3 months of screening and
randomization.
5) Heart failure New York Heart Association (NYHA) class IV
6) History of hemorrhagic stroke or other major bleeding
7) Severe concomitant non-CV disease that is expected to reduce life expectancy
to less than 5 years, at Screening or at Randomization visit
8) Pregnant or nursing woman
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method