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 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. Contact Information Contact Name Katherine Armstrong CRC Contact Phone 571-472-2918 Contact Email Send Email Contact Information Contact Name Henry Tran, MD Contact Phone 571-472-2915 Contact Email Send Email