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).

Phase 3

Recruiting

Conditions: Major Adverse Cardiovascular Events (MACE)
10082206
10003216
increased 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

Inclusion Criteria

- 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

Exclusion Criteria

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
<p>The primary objectives of this study is to demonstrate the superiority of<br /><br>pelecarsen (TQJ230) compared to placebo in reducing the risk of expanded MACE<br /><br>(cardiovascular death, non-fatal MI, non-fatal stroke and urgent coronary<br /><br>re-vascularization requiring hospitalization) in 1) the overall study<br /><br>population with established CVD (Lp(a) >= 70 mg/dL) and/or 2) in a subpopulation<br /><br>with established CVD and Lp(a) >= 90 mg/dL.<br /><br><br /><br><br /><br>See protocol 2 (p.22-23)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>In the overall trial population and in the subpopulation (>= 90 mg/dL):<br /><br>Demonstrate the superiority of pelacarsen (TQJ230) compared to placebo in<br /><br>reducing the risk of the MACE composite of CV death, non-fatal MI and non-fatal<br /><br>stroke.<br /><br>Demonstrate the superiority of pelacarsen (TQJ230) compared to placebo in<br /><br>reducing the risk of the composite of coronary heart disease (CHD) outcomes:<br /><br>death due to CHD, non-fatal MI and urgent coronary re-vascularization requiring<br /><br>hospitalization.<br /><br>Demonstrate the superiority of pelacarsen (TQJ230) compared to placebo in<br /><br>lowering the Lp(a) level at 1 year.<br /><br>Evaluate the rate of all cause death.<br /><br><br /><br>See protocol 2 (p.23)</p><br>