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8110 Gatehouse Road, Falls Church, VA 22042

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)

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General Information

Age Group

Adults

Status

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.