Assessing the Impact of Lipoprotein (a) Lowering With TQJ230 on Major Cardiovascular Events in Patients With CVD
A Randomized Double-blind, Placebo-controlled, Multicenter Trial Assessing the Impact of Lipoprotein (a) Lowering With TQJ230 on Major Cardiovascular Events in Patients With Established Cardiovascular Disease
ClinicalTrials.gov Identifier: NCT04023552
Novartis Reference Number: CTQJ230A12301
Last Update: Jan 15, 2021
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
Study Description
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)
Interventions
Eligibility Criteria
Key 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
Key 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 Locations
Contacts
Have a question?
Call 1-888-669-6682 or email [email protected]