Vanderbilt Clinical Trials

Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD

Purpose

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)

Condition

Cardiovascular Disease and Lipoprotein(a)

Eligibility

Eligible Ages: Between 18 Years and 80 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Lp(a) ≥ 70 mg/dL at the screening visit, measured at the Central laboratory - Myocardial infarction: ≥ 3 months from screening and randomization to ≤ 10 years prior to the screening visit - Ischemic stroke: ≥ 3 months from screening and randomization to ≤ 10 years prior to the screening visit - Clinically significant symptomatic peripheral artery disease

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 Other protocol-defined inclusion/exclusion criteria may apply at the end.

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Experimental TQJ230	TQJ230 80 mg injected monthly administered subcutaneously	Drug: TQJ230 TQJ230 80 mg injected monthly administered subcutaneously
Placebo Comparator Placebo	Monthly subcutaneous injections.	Drug: Placebo Placebo to match TQJ230 prefilled syringe to be injected subcutaneously Other names: Placebo to match TQJ230

More Details

Status: Active, not recruiting
Sponsor: Novartis Pharmaceuticals

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.