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 (Horizon)

General Information

Age Group

Adults

Status

Active, not recruiting

Protocol Number

NCT04023552

Background Information

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).

Offered At

Inova Cardiology-Fairfax
8081 Innovation Park Drive, Suite 700
Fairfax, VA 22031
Principal Investigator

Henry Tran, MD

Eligibility Information

  • 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 from screening and randomization visits to ≤ 10 years prior to the screening visit, and/or
  • Ischemic stroke: ≥ 3 months from screening and randomization visits to ≤ 10 years prior to the screening visit

Ineligibility Information

  • 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 < 140,000 per mm3
  • Active liver disease or hepatic dysfunction
  • Significant kidney disease
  • Pregnant or nursing women

Additional information can be found at https://clinicaltrials.gov/ct2/show/NCT04023552

Study Publication:
Plakogiannis R, Sorbera M, Fischetti B, Chen M. The Role of Antisense Therapies Targeting Lipoprotein(a). J Cardiovasc Pharmacol. 2021 Jul 1;78(1):e5-e11. doi: 10.1097/FJC.0000000000001045. Review.