A Randomized Double-blind, Placebo-controlled, Multicente... | EligiMed

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

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT04023552RENIS: IS002971Tipo: INTERVENTIONALInicio: 12 de dic de 2019Fin estimado: 30 de jun de 2026

Traducción no disponible, mostrando original

Resumen

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)

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

TQJ230

TQJ230 80 mg injected monthly administered subcutaneously

drug

Placebo

Placebo to match TQJ230 prefilled syringe to be injected subcutaneously

Ubicaciones

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

Mar del Plata, Buenos Aires, Argentina

Novartis Investigative Site

Ramos Mejía, Buenos Aires, Argentina

Novartis Investigative Site

Córdoba, Córdoba Province, Argentina

Novartis Investigative Site

San Miguel de Tucumán, San Miguel de Tucuman, Argentina

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Novartis Investigative Site

Santa Fe, Santa Fe Province, Argentina

Novartis Investigative Site

San Miguel Tucuman, Tucumán Province, Argentina

Novartis Investigative Site

Caba, Argentina

Novartis Investigative Site

Capital Federal, Argentina

Novartis Investigative Site

Corrientes, Argentina

Novartis Investigative Site

Córdoba, Argentina

Novartis Investigative Site

San Luis, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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