A randomized double-blind, placebo-controlled, multicentertrial assessing the impact of lipoprotein (a) lowering withTQJ230 on major cardiovascular events in patients withestablished cardiovascular disease
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 7,680
- Locations
- 50
- Primary Endpoint
- Demonstrate the superiority of TQJ230 compared to placebo in reducing the risk of expanded MACE (cardiovascular
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Written informed consent must be obtained before any assessment is performed.
- •Male and female 18 to ≤ 80 years of age
- •Lp(a) ≥ 70 mg/dL at the screening visit, measured at the Central laboratory
- •LDL-cholesterol lowering treatment at Randomization as follows: a.
- •subjects must be on an optimal LDL-C lowering treatment to meet the target LDL-C level according to local practice/guidelines, or b.
- •if subjects do not meet the target LDL-C level according to local practice/guidelines, they should be treated with the highest tolerated doses of statins and/or with other optimized LDL-lowering therapy (e.g. ezetimibe, cholesterol absorption inhibitor, fibrate, PCSK9 inhibitor), or c.
- •if subjects have a contraindication or do not tolerate statin treatment, they must be treated with other optimized LDL-lowering therapy (e.g. ezetimibe, cholesterol absorption inhibitor, fibrate, PCSK9 inhibitor) according to local practice/guidelines
- •At the randomization visit subjects must be optimally treated for other CV risk factors according to local practice/guidelines.
Exclusion Criteria
- •Uncontrolled hypertension defined as sitting systolic blood pressure (SBP) ≥ 160 mmHg and/ or diastolic blood pressure (DBP) ≥ 100 mmHg (mean of 3 measurements for each SBP and DBP assessment) at the Screening visit.
- •Treatment with niacin in the 3 months before the screening visit; niacin in multi-vitamins is allowed
- •Treatment with stable dose of a PCSK9 inhibitor (evolocumab, alirocumab) for less than 12 weeks before Randomization
- •Treatment with lipoprotein apheresis, or already planned to start lipoprotein apheresis during the study
- •Within 3 months of screening and between Screening visit and Randomization visit (Day 1): myocardial infarction, stroke, coronary or lower limb re-vascularization, major cardiac or non-cardiac surgery.
- •The subjects can be re-screened 3 months after the relevant event/procedure.
- •Planned or expected cardiac, cerebrovascular or peripheral artery surgery or coronary revascularization after Randomization visit (Day 1)
- •Heart failure New York Heart Association (NYHA) class IV at Screening visit or at Randomization visit (Day 1)
- •History of hemorrhagic stroke or other major bleeding, or if occurring between Screening visit and Randomization visit.
Outcomes
Primary Outcomes
Demonstrate the superiority of TQJ230 compared to placebo in reducing the risk of expanded MACE (cardiovascular
Time Frame: Time to the first occurrence of CEC confirmed | expanded MACE (cardiovascular death, nonfatal | MI, non-fatal stroke and urgent coronary | re-vascularization requiring hospitalization) in a | population of patients with elevated Lp(a) ≥ 70 | mg/dL and in a subpopulation of patients | with elevated Lp(a) ≥ 90 mg/dL
death, non-fatal MI, non-fatal stroke and urgent coronary re-vascularization
Time Frame: Time to the first occurrence of CEC confirmed | expanded MACE (cardiovascular death, nonfatal | MI, non-fatal stroke and urgent coronary | re-vascularization requiring hospitalization) in a | population of patients with elevated Lp(a) ≥ 70 | mg/dL and in a subpopulation of patients | with elevated Lp(a) ≥ 90 mg/dL
requiring hospitalization) in the overall study population with established CVD
Time Frame: Time to the first occurrence of CEC confirmed | expanded MACE (cardiovascular death, nonfatal | MI, non-fatal stroke and urgent coronary | re-vascularization requiring hospitalization) in a | population of patients with elevated Lp(a) ≥ 70 | mg/dL and in a subpopulation of patients | with elevated Lp(a) ≥ 90 mg/dL
and (Lp(a) ≥ 70 mg/dL) and/or Lp(a) ≥ 90 mg/dL.
Time Frame: Time to the first occurrence of CEC confirmed | expanded MACE (cardiovascular death, nonfatal | MI, non-fatal stroke and urgent coronary | re-vascularization requiring hospitalization) in a | population of patients with elevated Lp(a) ≥ 70 | mg/dL and in a subpopulation of patients | with elevated Lp(a) ≥ 90 mg/dL
Secondary Outcomes
- Time to the first occurrence of the clinical endpoint committee confirmed composite endpoint of major adverse cardiovascular events (CV death, non-fatal MI, and non-fatal stroke)(Demonstrate the superiority of TQJ230 compared to placebo in reducing the risk of the MACE composite of CV death, nonfatal MI and non-fatal stroke.)
- Time to the first occurrence of the clinical endpoint committee confirmed composite endpoint of coronary heart disease: coronary heart disease death, non-fatal MI, urgent coronary re-vascularization requiring hospitalization(Demonstrate the superiority of TQJ230 compared to placebo in reducing the risk of the composite of coronary heart disease (CHD) outcomes: death due to CHD, nonfatal MI and urgent coronary revascularization requiring hospitalization.)
- Number of participants with confirmed all-cause death(Evaluation by clinical endpoint committee the rate of all-cause death)