Идёт набор NCT07000357

A Phase III Study of AZD0780 on Major Adverse CV Events in Patients With a History of ASCVD Events or at High Risk for a First Event

Фаза III С лечением Cardiovascular Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: AZD0780, Placebo.
Кому может быть актуально: Состояния в реестре: Cardiovascular Disease. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Аргентина, Бразилия, Болгария, Канада +31
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Effect of AZD0780 on Major Adverse Cardiovascular Events in Patients With Established Atherosclerotic Cardiovascular Disease (ASCVD) or at High Risk for a First ASCVD Event

Обзор

The purpose of this phase 3, randomized, placebo controlled, event-driven study is to assess the effect of AZD0780, an oral PCSK9 inhibitor, compared with placebo in reducing the risk of MACE-PLUS in patients with established ASCVD or at high risk for a first ASCVD event. The effect of AZD0780 vs placebo on the risk of MACE-PLUS will be evaluated from randomisation until the primary analysis censoring date (PACD). The Study Closure Visit will be scheduled to occur after the PACD and will be the final visit for each participant in the study.

Вмешательства

Препарат AZD0780
Participants will receive oral AZD0780 once daily
Препарат Placebo
Participants will receive oral placebo once daily

Первичные конечные точки

Time to first event of any component of MACE-PLUS [Срок оценки: Up to approximately 54 months]

Вторичные конечные точки (7)

Time to first event of any component of 3P MACE [Срок оценки: Up to approximately 54 months]
Time to first event of any component of MACE PLUS [Срок оценки: Up to approximately 54 months]
Time to first event of MI [Срок оценки: Up to approximately 54 months]
Time to first event of urgent coronary revascularisation [Срок оценки: Up to approximately 54 months]
Time to CV death [Срок оценки: Up to approximately 54 months]
Time to first event of MALE [Срок оценки: Up to approximately 54 months]
Time to all-cause mortality [Срок оценки: Up to approximately 54 months]

Критерии участия

Критерии включения

Meets one of the following:

Participants with history of an ASCVD event: Participants ≥ 18 years of age at the time of signing the ICF with a history of MI or ischaemic stroke suspected to be due to atherosclerotic vascular disease ≥ 1 month prior to randomisation (presumed lacunar or cardioembolic strokes are not qualifying events), or revascularisation for symptomatic lower limb PAD any time prior to screening

Additional risk factors based on the level of the LDL-C and timing of MI or stroke:

o Participants with an LDL-C ≥ 75 mg/dL (≥ 1.9 mmol/L) need to have at least one of the other additional risk factors (i to viii) below.

ii) T2DM requiring ongoing medical therapy iii) Age ≥ 65 years v) Previous above ankle amputation due to PAD vi) Previous diagnosis of non-end stage CKD

Participants at increased risk of a first ASCVD event: Male participant ≥ 50 years of age or female participant ≥ 55 years of age at the time of signing the ICF with LDL-C ≥ 100 mg/dL (≥ 2.6 mmol/L), with no prior history of MI, ischaemic stroke due to atherosclerotic disease, or leg revascularisation for symptomatic lower limb PAD, and with diagnostic evidence of at least one of the following disease categories (i, ii, or iii):

(i) Significant atherosclerotic artery disease (ii) High-risk Type 1 or Type 2 diabetes mellitus with manifestation of at least one of the following end-organ diseases:

Nephropathy - Persistent (≥ 2 readings) microalbuminuria (urine albumin/creatinine ratio ≥ 30 mg/g) and/or persistent eGFR < 60 mL/min/1.73 m2. At least one reading must come from the medical record within the last 12 months in addition to the reading from screening
Retinopathy - Treated diabetic retinopathy (surgical intervention or injectable therapy) or prior diagnosis made by a relevant healthcare specialist
Neuropathy - Treated neuropathy (medical therapy for pain relief or symptom alleviation) or prior diagnosis made by a relevant healthcare specialist
ABI < 0.9 or > 1.4 - confirmed either in study during screening or randomisation, or from the medical record within the last 5 years (iii) Documented atherosclerosis of less significance

For (ii) and (iii), participants need to have at least one of the additional risk factors below:

CKD with eGFR x mL/min/1.73 m2
Current tobacco use
Age ≥ 65
T2DM (if included on the less significant atherosclerosis criterion iii)
Participants should receive a background lipid lowering regimen anticipated to achieve at least a \~50% reduction in LDL-C. Except in cases of intolerance, the regimen should include a high intensity statin therapy or lower intensity statin therapy in combination with an oral agent with proven outcome benefit (eg, ezetimibe and/or bempedoic acid).

Participants must achieve a stable background lipid lowering therapy > 28 days before screening.

Критерии исключения

Any underlying known disease, or condition including homozygous familial hypercholesterolaemia, or LDL or plasma apheresis within 12 months prior to randomisation, that, in the opinion of the investigator, might interfere with the interpretation of the clinical study results.
Any revascularisation procedure planned within the next 3 months.
Available imaging assessment within the last 3 years showing either coronary calcium score of zero, or a coronary computed tomography angiography with no atherosclerosis.
Calculated eGFR < 15 mL /min/1.73 m2 at screening.
Any laboratory values with the following deviations at screening:

AST or ALT > 3 × ULN
TBL > 2 × ULN (except for participants with Gilbert's syndrome where TBL 3 × ULN is acceptable provided direct bilirubin < 1.5 × ULN)
Fasting triglycerides ≥ 400 mg/dL (≥ 4.52 mmol/L).
Creatine kinase > 5 × ULN
Urine albumin/creatinine ratio ≥ 500 mg/g
Uncontrolled T2DM defined as HbA1c ≥ 9.5% at screening.
Inadequately treated hypothyroidism defined as TSH > 1.5 × ULN at screening or participants whose thyroid replacement therapy was initiated or modified within the last 3 months prior to screening.
Use of mipomersen or lomitapide (cholesterol-lowering medications) within 12 months of screening or planned use during the study.
Use of gemfibrozil within one week prior to the Screening Visit or planned use during the study.
Use of PCSK9 inhibitors: evolocumab/alirocumab within 12 weeks of the Screening Visit or planned use during the study, or inclisiran within 18 months of the Screening Visit or planned use during the study, or any other approved PCSK9 inhibitor use within 5 half lives prior to the Screening Visit or planned use during the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение: Рандомизированное
Модель: Параллельные группы
Маскирование: Четверное слепое
Основная цель: Лечение