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