Yangxinshi Tablet Intervention for Exercise Capacity in Patients With Chronic Coronary Syndrome

Официальное название

Yangxinshi Tablet Intervention for Exercise Capacity in Patients With Chronic Coronary Syndrome: Prospective, Multicentre, Randomized, Open-label, Blinded-endpoint Clinical Trial

Обзор

This study is a prospective, multicentre, randomized, open-label, blinded-endpoint clinical trial to evaluate the efficacy and safety of Yangxinshi tablets in the treatment of patients with chronic coronary syndrome (CCS).

Подробное описание

This study plans to enrol 1200 CCS patients. A central randomized control group will be set up. The experimental and control groups will be populated at a 3:1 ratio. In addition to basic medication, the experimental group will be given Yangxinshi tablets (three tablets each time, three times a day); the control group will be given basic medication only. The treatment period is 24 weeks. The primary efficacy indicator is the 6-minute walking distance (6MWD).

Вмешательства

• Препарат Yangxinshi tablet
  In addition to basic medication, the experimental group will be given Yangxinshi (three tablets each time, three times a day);The treatment period is 24 weeks.
• Другое Basic medication
  The control group will be given basic medication only. The treatment period is 24 weeks.

Первичные конечные точки

• 6MWD [Срок оценки: 24 weeks after treatment]

Вторичные конечные точки (2)

• Borg scale [Срок оценки: 24 weeks after treatment]
• MACCE [Срок оценки: after 4, 8, 12, 16, 20, and 24 weeks of treatment]

Критерии участия

Критерии включения

• age 18-75 years;
• CCS patients in stable condition and clearly diagnosed by coronary artery imaging (at least one vessel stenosis ≥ 50%): stable angina, ischaemic cardiomyopathy, asymptomatic or stable symptoms, occult coronary heart disease, acute coronary syndrome (ACS), or >3 months after coronary revascularization;
• moderately to severely limited exercise tolerance: the maximum 6MWD is < 450 m, or the metabolic equivalent (MET) as measured by treadmill cardiopulmonary exercise testing is < 5 METs;
• voluntary participation and signing of informed consent.

Критерии исключения

• absolute or relative contraindications for the treadmill cardiopulmonary exercise test or 6-minute walk test (6MWT);
• serious primary diseases, mental diseases, or malignant tumours that affect lifespan;
• pregnancy, intended or suspected pregnancy, miscarriage, breastfeeding, or delivery in the last 6 months;
• subjects not suitable for this study in the opinion of the researchers, such as subjects who are participating in other drug clinical trials or intervention studies.

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 · 32 центра

• Shapingba District People's Hospital of Chongqing — Чунцин
• Zhengzhou Seventh People's Hospital — Чжэнчжоу
• Binzhou Medical University Hospital — Binzhou
• Binzhou People's Hospital — Binzhou
• Dezhou Municiple Hospital — Dezhou
• Pingyuan County first People's Hospital — Dezhou
• Feicheng People's Hospital — Feicheng
• Shandong Health Group Feicheng Hospital — Feicheng
• … и ещё 24 центра

Идентификаторы

NCT: NCT06171061 · GrowfulPower-008

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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