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Набор скоро начнётся NCT07615296

Target-Oriented Strategy of Ultra-Low LDL-C (<1.0 vs. 1.0-1.39 mmol/L) in Extreme-High-Risk ASCVD Patients: Clinical Benefit, Safety and Cost-Effectiveness Assessment

Без фазы С лечением Atherosclerotic Cardiovascular Disease (ASCVD)

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: Lipid-lowering therapy targeting LDL-C <1.0 mmol/L, Lipid-lowering therapy targeting LDL-C 1.0-1.39 mmol/L.
Кому может быть актуально
Состояния в реестре: Atherosclerotic Cardiovascular Disease (ASCVD). Базовые параметры: 18 лет — 80 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
Китай
Следующий шаг
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Официальное название

Target-Oriented Strategy of Ultra-Low LDL-C Goal in Extreme-High-Risk ASCVD Patients (<1.0 vs. 1.0-1.39 mmol/L): Clinical Benefit, Safety and Cost-Effectiveness Assessment- A Multicenter, Prospective, Randomized, Open-Label, Blinded-Endpoint Adaptive Trial

Обзор

The goal of this clinical trial is to learn whether an ultra-low LDL-C target (\<1.0 mmol/L) can improve clinical outcomes compared with a moderately low LDL-C target (1.0-1.39 mmol/L) in Chinese patients with extreme-high-risk atherosclerotic cardiovascular disease (ASCVD). It also aims to evaluate long-term safety and cost-effectiveness, and explore potential benefit subgroups and underlying mechanisms. The main questions it aims to answer are: Does an LDL-C target \<1.0 mmol/L reduce major adverse cardiovascular events (MACE-4: cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, urgent coronary revascularization) compared with a target of 1.0-1.39 mmol/L?What are the long-term safety risks including cognitive decline, hemorrhagic stroke, new-onset diabetes, new malignancies and severe adverse drug reactions under different LDL-C targets?Researchers will compare participants receiving an LDL-C target \<1.0 mmol/L with those receiving a target of 1.0-1.39 mmol/L to see if the ultra-low LDL-C strategy provides better clinical benefit with acceptable safety and economic value. Participants will: Receive lipid-lowering therapy following a mandatory titration-maintenance-off-target correction algorithm according to their assigned LDL-C target Undergo routine follow-up every 3 months, cognitive assessment every 6 months, and comprehensive annual re-examinations for a median of 2 years and up to 5 years Have centralized blinded lipid testing and endpoint adjudication by an independent Clinical Event Committee

Вмешательства

  • Препарат Lipid-lowering therapy targeting LDL-C <1.0 mmol/L
    Statin-ezetimibe-based lipid-lowering therapy with mandatory titration-maintenance-off-target correction algorithm. PCSK9 inhibitor is sequentially added and dose-adjusted based on centralized blinded lipid test results to achieve LDL-C level \<1.0 mmol/L.
  • Препарат Lipid-lowering therapy targeting LDL-C 1.0-1.39 mmol/L
    Standard statin-ezetimibe lipid-lowering therapy. Mandatory dose reduction (discontinue ezetimibe → halve statin → discontinue statin) will be performed if LDL-C drops below 1.0 mmol/L, to maintain LDL-C within 1.0-1.39 mmol/L.

Первичные конечные точки

  • Major Adverse Cardiovascular Events-4 (MACE-4) [Срок оценки: Median 2 years, up to 5 years from randomization]
Вторичные конечные точки (4)
  • All-cause mortality [Срок оценки: Median 2 years, up to 5 years post-randomization]
  • Major Adverse Cardiovascular Events-3 (MACE-3) [Срок оценки: Median 2 years, up to 5 years post-randomization]
  • individual components of MACE-4 [Срок оценки: Median 2 years, up to 5 years post-randomization]
  • LDL-C target achievement rate [Срок оценки: Median 2 years, up to 5 years post-randomization]

Критерии участия

Критерии включения

  • Aged 18-80 years, any sex.
  • Diagnosed with ultra-high-risk ASCVD per 2023 Chinese Lipid Guidelines: either ≥2 major ASCVD events within 24 months, or 1 major ASCVD event plus ≥2 high-risk factors (diabetes, multi-vessel disease, premature CHD family history, elevated Lp(a), hypertension).
  • LDL-C ≥1.0 mmol/L after ≥4-week maximum-tolerated statin plus ezetimibe therapy, confirmed by central laboratory.
  • Able to complete follow-up and examinations; no severe hepatic/renal dysfunction.
  • Voluntary participation with written informed consent.

Критерии исключения

  • Hypersensitivity or intolerance to statins, ezetimibe, or PCSK9 inhibitors.
  • Hemorrhagic stroke, active bleeding, severe trauma or major surgery within 6 months before enrollment.
  • Malignancy (expected survival <3 years), severe liver/kidney disease, or autoimmune disease.
  • Cognitive impairment (MoCA <20) or psychiatric disorders precluding assessment cooperation.
  • Pregnant, breastfeeding, or planning pregnancy during the trial.
  • Participation in other clinical trials or use of other lipid-lowering drugs within 3 months.
  • Poor compliance or other conditions judged by investigators to interfere with 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
Простое слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Beijing Anzhen Hospital, Capital Medical University — Пекин

Идентификаторы

NCT: NCT07615296 · LIPID-2026-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗