Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD
- Conditions
- Cardiovascular Disease and Lipoprotein(a)
- Interventions
- Drug: Placebo
- Registration Number
- NCT04023552
- Lead Sponsor
- Novartis Pharmaceuticals
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 8323
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Monthly subcutaneous injections. TQJ230 TQJ230 TQJ230 80 mg injected monthly administered subcutaneously
- Primary Outcome Measures
Name Time Method Time to first occurrence of clinical endpoint committee confirmed expanded major adverse cardiovascular events in patients with elevated Lp(a) ≥ 70 mg/dL approximately 4 years Demonstrate the superiority of pelacarsen (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 the overall study population with established CVD and (Lp(a) ≥ 70 mg/dL)
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. approximately 4 years Demonstrate the superiority of pelacarsen (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 the overall study population with established CVD and (Lp(a) ≥ 90 mg/dL)
- Secondary Outcome Measures
Name Time Method 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 approximately 4 years Demonstrate the superiority of pelacarsen (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.
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) approximately 4 years Demonstrate the superiority of pelacarsen (TQJ230) compared to placebo in reducing the risk of the MACE composite of CV death, nonfatal MI and non-fatal stroke.
Time to Clinical endpoint Committee confirmed all-cause death approximately 4 years Evaluation by clinical endpoint committee the rate of all-cause death
Change in Lp(a) in the log scale from baseline Baseline, year 1 Demonstrate the superiority of pelacarsen (TQJ230) compared to placebo in lowering the Lp(a) level at 1 year
Trial Locations
- Locations (32)
SEC Clinical Research LLC
🇺🇸Andalusia, Alabama, United States
Novartis Investigative Site
🇬🇧Wrexham, United Kingdom
Mercy Gilbert Medical Center
🇺🇸Gilbert, Arizona, United States
Cardiovascular Res Found
🇺🇸Beverly Hills, California, United States
University of California San Diego
🇺🇸San Diego, California, United States
UCSF
🇺🇸San Francisco, California, United States
East Coast Institute for Research
🇺🇸Jacksonville, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Horizon Research Grp
🇺🇸Lafayette, Louisiana, United States
Tulane Uni Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Grace Research Llc
🇺🇸Shreveport, Louisiana, United States
Genesys Regional Medical Center
🇺🇸Grand Blanc, Michigan, United States
Saint Johns Hospital
🇺🇸Maplewood, Minnesota, United States
Mercy South
🇺🇸Saint Louis, Missouri, United States
Mercy Hospital St Louis
🇺🇸Saint Louis, Missouri, United States
Albany Medical College
🇺🇸Albany, New York, United States
Lenox Hill Hospital
🇺🇸New York, New York, United States
Rochester Regional Health
🇺🇸Rochester, New York, United States
Strong Memorial Hospital
🇺🇸Rochester, New York, United States
Medication Management LLC
🇺🇸Greensboro, North Carolina, United States
Accellacare US Inc
🇺🇸Raleigh, North Carolina, United States
Wake Forest University Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Akron Hospital Summa Health System
🇺🇸Akron, Ohio, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Cardiovascular Res of Knoxville LLC
🇺🇸Powell, Tennessee, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Grace Research
🇺🇸Marshall, Texas, United States
The University of Utah
🇺🇸Salt Lake City, Utah, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Univ of Washington Medical Center
🇺🇸Seattle, Washington, United States
West Virginia University Hospital
🇺🇸Morgantown, West Virginia, United States