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Активно (без набиране) Фаза 3 NCT05581303

Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial

Фаза 3 – широко изпитване преди одобрение
Заболявания: Atherosclerotic Cardiovascular Disease

Спонсор: Amgen

Налично на: БГ
Обобщение
The primary objective of this trial is to compare the effect of treatment with olpasiran, to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants with atherosclerotic cardiovascular disease (ASCVD) and elevated Lipoprotein(a).
Кой може да участва
Inclusion Criteria: * Age 18 to ≤ 85 years * Lp(a) ≥ 200 nmol/L during screening * History of ASCVD as evidenced by history of either: * Myocardial infarction (presumed type 1 event due to plaque rupture/erosion) and/or * Coronary revascularization with percutaneous coronary intervention AND at least 1 additional risk factor. Exclusion Criteria: * Severe renal dysfunction * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 x upper limit of normal (ULN), or total bilirubin (TBL) \> 2 x ULN during screening * History of hemorrhagic stroke * History of major bleeding disorder * Planned cardiac surgery or arterial revascularization * Severe heart failure * Current, recent, or planned lipoprotein apheresis * Previously received ribonucleic acid therapy specifically targeting Lp(a)
Места на провеждане 31
Argentina (1)
Instituto de Investigaciones Clinicas Bahia Blanca
Bahía Blanca , Buenos Aires
Австралия (1)
Canberra Hospital
Garran , Australian Capital Territory
Белгия (1)
Algemeen Stedelijk Ziekenhuis Aalst
Aalst
Бразилия (1)
Hospital Universitario Walter Cantidio
Fortaleza , Ceará
България (1)
Multiprofile Hospital for Active Treatment Puls AD
Blagoevgrad
Канада (1)
ARC Biosystems Incorporated
Vancouver , British Columbia
Китай (1)
Peking University Third Hospital
Beijing , Beijing Municipality
Чехия (1)
Jessenia as, Nemocnice Beroun
Beroun
Дания (1)
Aalborg Universitetshospital
Aalborg
Estonia (1)
Innomedica
Tallinn
Финландия (1)
Helsinki University Central Hospital
Helsinki
Франция (1)
Centre Hospitalier Regional Universitaire de Besancon, Hopital Jean Minjoz
Besançon
Гърция (1)
General Hospital of Athens Evaggelismos
Athens
Hong Kong (1)
University of Hong Kong, Queen Mary Hospital
Hong Kong
Унгария (1)
Lausmed Kft
Baja
Iceland (1)
Hjartamidstodin
Kopavogur
Италия (1)
Ospedali dell Ovest Vicentino
Arzignano
Япония (1)
Kasugai Municipal Hospital
Kasugai-shi , Aichi-ken
Lithuania (1)
Klinikiniai sprendimai
Alytus
Mexico (1)
Virgen Cardiovascular Research SC
Guadalajara , Jalisco
Нидерландия (1)
Meander Medisch Centrum
Amersfoort
Норвегия (1)
Oslo Universitetssykehus HF Aker sykehus
Oslo
Полша (1)
American Heart of Poland Spolka Akcyjna
Bełchatów
Румъния (1)
cmi Cardiologie - Dr Mercea Corina Delia
Baia Mare
Словакия (1)
Alian, sro
Bardejov
Южна Корея (1)
Dong-A University Hospital
Busan
Испания (1)
Hospital Universitario Reina Sofia
Córdoba , Andalusia
Швеция (1)
Falu Lasarett
Falun
Taiwan (1)
Hualien Tzu Chi Hospital
Hualien City , Hualien
Великобритания (1)
Ormeau Clinical Trials Ltd
Belfast
САЩ (1)
Ascension Saint Vincents Birmingham
Birmingham , Alabama
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
85 Years
Здрави доброволци
Не
Начална дата
14.12.2022
Крайна дата
31.03.2028
Регистрационен номер
NCT05581303
Източник
anzctr
Запитване за медицински туризъм

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