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Набира участници Фаза 3 NCT07293260

Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction - Coronary Computed Tomography Angiography Trial

Фаза 3 – широко изпитване преди одобрение
Заболявания: Cardiovascular Disease

Спонсор: Amgen

Налично на: БГ
Обобщение
The primary objective of this trial is to evaluate the effect of olpasiran, compared to placebo, on non-calcified plaque (NCP) volume as measured by Coronary Computed Tomography Angiography (CCTA).
Кой може да участва
Inclusion Criteria: * Age 35 to ≤ 80 years. * Lp(a) ≥ 200 nmol/L during screening. * Angiographic evidence of coronary artery disease in at least one major epicardial vessel on screening CCTA. * History of myocardial infarction (presumed type 1 event due to plaque rupture/erosion) and/or coronary revascularization by percutaneous coronary intervention. Exclusion Criteria: * History of coronary artery bypass graft (CABG). * Moderate to 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 10
Австралия (1)
Advara HeartCare Wesley
Auchenflower , Queensland
Канада (1)
North York Diagnostic and Cardiac Centre
Vaughan , Ontario
Китай (1)
Peking University First Hospital
Beijing , Beijing Municipality
Дания (1)
Regionshospitalet Gødstrup
Herning
Франция (1)
Centre Hospitalier Universitaire de Nice - Hopital Pasteur
Nice
Италия (1)
Azienda Ospedaliera Universitaria di Ferrara Arcispedale Sant Anna
Ferrara
Япония (1)
Tomakomai City Hospital
Tomakomai-shi , Hokkaido
Нидерландия (1)
Tergooiziekenhuizen, locatie Hilversum
Hilversum
Испания (1)
Hospital Universitario Virgen Macarena
Seville , Andalusia
САЩ (1)
Bridgeport Hospital
Bridgeport , Connecticut
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
35 Years
Максимална възраст
80 Years
Здрави доброволци
Не
Начална дата
23.03.2026
Крайна дата
15.06.2028
Регистрационен номер
NCT07293260
Източник
anzctr
Запитване за медицински туризъм

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