General Information
Age Group
AdultsStatus
Active, not recruitingProtocol 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.