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Active (not recruiting) Phase 3 NCT05581303

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

Phase 3 – large-scale trial before approval
Conditions: Atherosclerotic Cardiovascular Disease

Sponsor: Amgen

trial.available_in: БГ
Overview
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).
Who can participate
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)
Locations 31
Argentina (1)
Instituto de Investigaciones Clinicas Bahia Blanca
Bahía Blanca , Buenos Aires
Australia (1)
Canberra Hospital
Garran , Australian Capital Territory
Belgium (1)
Algemeen Stedelijk Ziekenhuis Aalst
Aalst
Brazil (1)
Hospital Universitario Walter Cantidio
Fortaleza , Ceará
Bulgaria (1)
Multiprofile Hospital for Active Treatment Puls AD
Blagoevgrad
Canada (1)
ARC Biosystems Incorporated
Vancouver , British Columbia
China (1)
Peking University Third Hospital
Beijing , Beijing Municipality
Czech Republic (1)
Jessenia as, Nemocnice Beroun
Beroun
Denmark (1)
Aalborg Universitetshospital
Aalborg
Estonia (1)
Innomedica
Tallinn
Finland (1)
Helsinki University Central Hospital
Helsinki
France (1)
Centre Hospitalier Regional Universitaire de Besancon, Hopital Jean Minjoz
Besançon
Greece (1)
General Hospital of Athens Evaggelismos
Athens
Hong Kong (1)
University of Hong Kong, Queen Mary Hospital
Hong Kong
Hungary (1)
Lausmed Kft
Baja
Iceland (1)
Hjartamidstodin
Kopavogur
Italy (1)
Ospedali dell Ovest Vicentino
Arzignano
Japan (1)
Kasugai Municipal Hospital
Kasugai-shi , Aichi-ken
Lithuania (1)
Klinikiniai sprendimai
Alytus
Mexico (1)
Virgen Cardiovascular Research SC
Guadalajara , Jalisco
Netherlands (1)
Meander Medisch Centrum
Amersfoort
Norway (1)
Oslo Universitetssykehus HF Aker sykehus
Oslo
Poland (1)
American Heart of Poland Spolka Akcyjna
Bełchatów
Romania (1)
cmi Cardiologie - Dr Mercea Corina Delia
Baia Mare
Slovakia (1)
Alian, sro
Bardejov
South Korea (1)
Dong-A University Hospital
Busan
Spain (1)
Hospital Universitario Reina Sofia
Córdoba , Andalusia
Sweden (1)
Falu Lasarett
Falun
Taiwan (1)
Hualien Tzu Chi Hospital
Hualien City , Hualien
United Kingdom (1)
Ormeau Clinical Trials Ltd
Belfast
United States (1)
Ascension Saint Vincents Birmingham
Birmingham , Alabama
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
85 Years
Healthy volunteers
No
Start date
14.12.2022
Completion date
31.03.2028
Registry ID
NCT05581303
Source
anzctr
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