Cardiovascular Disease MedDRA version: 21.1 Level: LLT Classification code 10051614 Term: Arteriosclerotic cardiovascular disease System Organ Class: 100000004866
Conditions
Interventions
Product Code: TQJ230
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: not yet assigned
CAS Number: 1637637-70-7
Current Sponsor code: TQJ230
Concentration unit: m
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
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 - Ischemic stroke: = 3 months to = 10 years prior to the screening visit - Clinically significant symptomatic peripheral artery disease Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 4800 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2880
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this study is to demonstrate the superiority of TQJ230 compared to placebo in reducing the risk of expanded MACE (cardiovascular death, non-fatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in 1) the overall study population with established CVD (Lp(a) = 70 mg/dL) and/or 2) in a subpopulation with established CVD and Lp(a) = 90 mg/dL. ;Secondary Objective: In the overall trial population and in subpopulation (= 90 mg/dL): Demonstrate the superiority of TQJ230 compared to placebo in reducing the risk of the MACE composite of CV death, non-fatal MI and non-fatal stroke. 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, non-fatal MI and urgent coronary re-vascularization requiring hospitalization . Evaluate the rate of all cause death. ;Primary end point(s): 1. Time to first occurrence of clinical endpoint committee confirmed expanded major adverse cardiovascular events in patients with elevated Lp(a) = 70 mg/dL 2.Time to the first occurrence of clinical endpoint committee confirmed expanded major adverse cardiovascular events in a population of patients with elevated Lp(a) = 90 mg/dL.;Timepoint(s) of evaluation of this end point: 4.25 years for both endpoints | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.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) 2.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 3.Number of participants with confirmed all-cause death;Timepoint(s) of evaluation of this end point: 4.25 years for the 3 endpoints | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Israel, Italy, Japan, Korea, Republic of, Lebanon, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactRegulatory Affairs
NOVARTIS FARMA S.p.A.
Outcome results
None listed