A Study Assessing Repatha® in Combination With Standard of Care (SOC) Compared With SOC on Major Cardiovascular Events in Chinese Participants With Atherosclerotic Cardiovascular Disease

Официальное название

A Real-world, Prospective, Observational Study Assessing the Effectiveness of Repatha® Used in Combination With Standard of Care Compared With Standard of Care Alone on Major Cardiovascular Events in Chinese Patients With Established Atherosclerotic Cardiovascular Disease

Обзор

The primary objective of the study is to evaluate real-world effectiveness of treatment with Repatha® in combination with SOC, compared with SOC alone, on the risk for cardiovascular (CV) death, myocardial infarction (MI), stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in participants with established atherosclerotic CV disease (ASCVD) treated with SOC, according to local clinical practice.

Первичные конечные точки

• Time to CV Death, MI, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization, Whichever Occurs First [Срок оценки: Up to 72 months]

Вторичные конечные точки (5)

• Time to CV Death, MI, or Stroke, Whichever Occurs First [Срок оценки: Up to 72 months]
• Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline [Срок оценки: Baseline and end of follow-up (up to 72 months)]
• Percent Change in LDL-C From Baseline [Срок оценки: Baseline and end of follow-up (up to 72 months)]
• Number of Participants Who Experienced Adverse Events [Срок оценки: Up to 72 months]
• Number of Participants Who Experienced Adverse Drug Reactions [Срок оценки: Up to 72 months]

Критерии участия

Критерии включения

• Adult participants ≥ 18 years of age.
• Participants or participant's legally authorized representative has provided informed consent to participate in this study.
• Participants who meet one of the following:
• Prescribed Repatha® in addition to an existing SOC treatment according to local guidelines and approved label.

OR

• Already received SOC treatment prior to enrollment.
• Participants with ANY of the following.
• Diagnosis of MI OR stroke within 2 years before enrollment.
• 2 MIs OR ≥ 2 strokes OR (≥ 1 MI AND ≥ 1 stroke) any time before enrollment.
• Diagnosis of (MI OR stroke) AND diabetes.
• Diagnosis of (MI OR stroke) AND documented multivessel disease (defined as > 50% stenosis of ≥ 2 major coronary arteries on coronary angiography or coronary artery contrast enhanced computed tomography).
• Diagnosis of symptomatic peripheral arterial disease.
• Most recent fasting LDL-C ≥ 70 mg/dL (≥ 1.8 mmol/L) or nonhigh-density lipoprotein cholesterol (non-HDL-C) ≥ 100 mg/dL (≥ 2.6 mmol/L) within 6 months prior to enrollment.
• Most recent fasting triglycerides ≤ 400 mg/dL (≤ 4.5 mmol/L) within 6 months prior to enrollment.

Критерии исключения

• Stroke within past 1 month.
• Known hemorrhagic stroke at any time.
• Stroke due to thromboembolic event.
• Any prior use of Repatha® or other proprotein convertase subtilisin/kexin type 9 inhibition treatments within past 6 months prior to enrollment.
• Participants currently enrolled in another study involving any investigational procedure, device or drug.
• Participants prescribed Repatha® with a history of severe hypersensitivity or allergy to any subsidiary.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 90 центров

• Beijing Anzhen Hospital, Capital Medical University — Пекин
• China Japan Friendship Hospital — Пекин
• Peking University First Hospital — Пекин
• Fuwai Hospital Chinese Academy of Medical Sciences — Пекин
• Beijing Friendship Hospital, Capital Medical University — Пекин
• Beijing Haidian Hospital — Пекин
• Peking University Third Hospital — Пекин
• Beijing Hospital — Пекин
• … и ещё 82 центра

Идентификаторы

NCT: NCT06295679 · 20180442

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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