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A Trial to Evaluate Efficacy of Heart-protecting Musk Pill

17 de dezembro de 2014 atualizado por: Shanghai Hutchison Pharmaceuticals Limited

A Randomized, Double-blind, Multi-centered, Placebo-controlled Trial to Examine Effects of Heart-protecting Musk Pill on Clinical Outcome in Patients With Chronic Stable Coronary Artery Disease

Title:

A randomized, double-blind, multi-centered, placebo-controlled trial to examine effects of of Heart-protecting Musk Pill on clinical outcomes in patients with chronic stable coronary artery disease

Objective:

To examine effects of of Heart-protecting Musk Pill, a traditional Chinese medicine, on clinical outcomes in patients with chronic stable coronary artery disease

The study hypothesis:

The null hypothesis: the combined incidence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke in the treatment group is the same as that in control group.

The alternative hypothesis: the combined incidence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke in the treatment group is different from that in control group.

Sample size:

2700 patients will be randomized, 1350 in treatment group and 1350 in placebo group.

Number of sites: 99 sites in China

Study drugs:

Heart-protecting Musk Pill and the matching placebo pills.

Design:

A randomized, double-blind, multi-centered, placebo-controlled trial. Patients will be randomized to treatment group and placebo group after screening and get corresponding treatment as follow.

Treatment group: Standard treatment for coronary artery disease plus 2 Heart-protecting Musk Pills each time, three times a day by mouth for 24 months.

Control group: Standard treatment for coronary artery disease plus 2 placebo pills each time, three times a day by mouth for 24 months.

Patients will be followed up at baseline, 1, 3, 6, 9, 12, 18, 24 months after randomization. During follow-up period, patients could undertake PCI or CABG if angina get out of control or evidence of ischemia aggravated is found.

Visão geral do estudo

Status

Desconhecido

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Antecipado)

2700

Estágio

  • Fase 4

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • China
    • Anhui
      • Hefei, Anhui, China, 230000
        • Anhui Provincial Hospital
      • Hefei, Anhui, China, 230000
        • The First Affiliated Hospital of Medical University Of Anhui
      • Maanshan, Anhui, China, 243000
        • MaAnShan Central Hospital
    • Beijing
      • Beijing, Beijing, China, 100000
        • Beijing An Zhen Hospital of the Capital University of Medical Sciences
      • Beijing, Beijing, China, 100000
        • Beijing hospital
      • Beijing, Beijing, China, 100000
        • Beijing Shijitan Hospital
      • Beijing, Beijing, China, 100000
        • Beijing Tongren Hospital Capital Medical University
      • Beijing, Beijing, China, 100000
        • Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
      • Beijing, Beijing, China, 100000
        • Navi General Hospital
      • Beijing, Beijing, China, 100000
        • Peking University First Hospital
    • Chongqing
      • Chongqing, Chongqing, China, 400000
        • Armed police Chongqing Corps Hospital
      • Chongqing, Chongqing, China, 400000
        • The Third People's Hospital of Chongqing
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Fujian Provincial Hospital
      • Fuzhou, Fujian, China, 350000
        • People's Hospital of Fujian Province
      • Putian, Fujian, China, 351100
        • The Affiliated Hospital of Putian University
      • Xiamen, Fujian, China, 361000
        • Xiamen Heart Center
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Affiliated Hospital of Guangzhou Medcal College
      • Guangzhou, Guangdong, China, 510000
        • The First Affiliated Hospital of Guangzhou University of Chinese Medicine
      • Guangzhou, Guangdong, China, 510000
        • The First Affiliated Hospital Sun Yat-Sen University
      • Jiangmen, Guangdong, China, 529000
        • The People's Hospital of Jiangmen
      • Shenzhen, Guangdong, China, 518000
        • Shenzhen people's hospital
      • Zhanjiang, Guangdong, China, 524000
        • The Affiliated Hospital of Guangdong Medical College
    • Guangxi
      • Liuzhou, Guangxi, China, 545000
        • The First People's Hospital of Liuzhou City
      • Nanning, Guangxi, China, 530000
        • The First Affiliated Hospital of Guangxi University of Chinese Medicine
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • HeBei General Hosital
      • Shijiazhuang, Hebei, China, 050000
        • The Seond Hospital of HeBei Medical University
      • Tangshan, Hebei, China, 063000
        • Tangshan Gongren Hospital
    • Heilongjiang
      • Daqing, Heilongjiang, China, 163000
        • DaQing General Hospial Group LongNan Hosptial
    • Henan
      • Kaifeng, Henan, China, 475000
        • Kaifeng Central Hospital
      • Zhengzhou, Henan, China, 450000
        • the First Affiliated Hospital of Zhengzhou University
      • Zhengzhou, Henan, China, 450000
        • People's Hospital of Henan Province
      • Zhengzhou, Henan, China, 450000
        • The first affiliated hospital of henan university of TCM
      • Zhengzhou, Henan, China, 450000
        • The Second Affiliated Hospital of Henan University of TCM
      • Zhengzhou, Henan, China, 450000
        • The Second Affiliated Hospital of Zhengzhou University
    • Hubei
      • Shiyan, Hubei, China, 442000
        • Taihe Hospital
      • Wuhan, Hubei, China, 430000
        • Renmin Hospital of Wuhan University
      • Wuhan, Hubei, China, 430000
        • Zhongnan Hospital of Wuhan University
      • Wuhan, Hubei, China, 430000
        • Hubei Provincial Corps Hospital of CPAPF
      • Xiangyang, Hubei, China, 441100
        • Xiangyang Central Hospital
    • Hunan
      • Changde, Hunan, China, 415000
        • The First People's Hospital of Changde
      • Changsha, Hunan, China, 410000
        • The Second Xiangya Hospital of Central South University
      • Changsha, Hunan, China, 410000
        • Xiangya Hospital Central-South University
      • Hengyang, Hunan, China, 421000
        • The First Affiliated Hospital of University of South China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
      • Nanjing, Jiangsu, China, 210000
        • JiangSu Province Hosptial of TCM
      • Nanjing, Jiangsu, China, 210000
        • JiangSu Province Hosptial
      • Nanjing, Jiangsu, China, 210000
        • Nanjing First Hospital
      • Nanjing, Jiangsu, China, 210000
        • NanJing Hospital of TCM
      • Suzhou, Jiangsu, China, 215000
        • Suzhou Municipal Hospital
      • Taizhou, Jiangsu, China, 225300
        • Jiangsu Taizhou People's Hospital
      • Wuxi, Jiangsu, China, 214000
        • Wuxi People's Hospital
      • Xuzhou, Jiangsu, China, 221000
        • The Affiliated Hospital of Xuzhou Medical College
      • Yangzhou, Jiangsu, China, 225000
        • Northern Jiangsu People's Hospital
      • Yangzhou, Jiangsu, China, 225000
        • YangZhou No. 1 People's Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China, 330000
        • The Second Affiliated Hospital of Nanchang University
      • Nanchang, Jiangxi, China, 330000
        • The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
      • Nanchang, Jiangxi, China, 330000
        • The First Hospital of Nanchang
    • Jilin
      • Changchun, Jilin, China, 160000
        • China-Japan Union Hospital of Jilin University
    • Liaoning
      • Anshan, Liaoning, China, 114000
        • The First Hospital of China Medical University
      • Dalian, Liaoning, China, 116000
        • The 210th Hospital of Chinese people's Liberation Army
      • Dalian, Liaoning, China, 116000
        • The second people's Hospital of Dalian
      • Shenyang, Liaoning, China, 110000
        • Affiliated Hospital of LiaoNing University of Traditional Chinese Medicine
      • Shenyang, Liaoning, China, 110000
        • the Fourth Affiliated Hospital of China Medical University
    • Shandong
      • Jinan, Shandong, China, 250000
        • Affiliated Hospital of Shandong University of TCM
      • Jinan, Shandong, China, 250000
        • Shangdong Provincial Hospital
      • Linyi, Shandong, China, 276000
        • Linyi People's Hospital
      • Qinan, Shandong, China, 250000
        • Qilu Hospital of Shandong University
      • Qingdao, Shandong, China, 264000
        • Qingdao University Medical College Affiliated Yuhuangding Hospital
      • Yantai, Shandong, China, 266000
        • The Affiliated Hospital of Medical College of Qingdao University
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Huadong Hospital Affiliated To Fudan University
      • Shanghai, Shanghai, China, 200000
        • Huashan Hospital Fudan University
      • Shanghai, Shanghai, China, 200000
        • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
      • Shanghai, Shanghai, China, 200000
        • Shanghai East Hospital
      • Shanghai, Shanghai, China, 200000
        • Shanghai First People's Hospital
      • Shanghai, Shanghai, China, 200000
        • ShuGuang Hospital
      • Shanghai, Shanghai, China, 200000
        • Tongji hospital affiliated to tongji university
      • Shanghai, Shanghai, China, 200000
        • Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
      • Shanghai, Shanghai, China, 200000
        • Zhongshan Hospital Fudan University
    • Shanxi
      • Taiyuan, Shanxi, China, 030000
        • Shanxi Medical University First Hospital
      • Taiyuan, Shanxi, China, 030000
        • Shanxi Medical University Second Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Sichuan Provincial People's Hospital
      • Luzhou, Sichuan, China, 646000
        • The Affiliated Hospital of Luzhou Medical College
      • Nanchong, Sichuan, China, 637000
        • Affiliated Hospital of Chuanbei Medical College
    • Tianjin
      • Tianjin, Tianjin, China, 300000
        • The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
      • Tianjin, Tianjin, China, 300000
        • TianHe Hospital
      • Tianjin, Tianjin, China, 300000
        • Tianjin Chest Hospital
      • Tianjin, Tianjin, China, 300000
        • Tianjin Third Central Hospital
    • Yunnan
      • Kunming, Yunnan, China, 650000
        • First People's Hospital of Yunnan Province
      • Kunming, Yunnan, China, 650000
        • Yunnan Provincial Hospital of Traditional Chinese Medicine
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • The Affiliated Hospital of Hangzhou Normal University
      • Hangzhou, Zhejiang, China, 310000
        • Hangzhou Traditional Chinese Medical Hospital
      • Hangzhou, Zhejiang, China, 310000
        • The First Affiliated Hospital Zhejiang University
      • Hangzhou, Zhejiang, China, 310000
        • Tongde Hospital of Zhejiang Province
      • Hangzhou, Zhejiang, China, 310000
        • Zhejiang Hospital
      • Hangzhou, Zhejiang, China, 310000
        • Zhejiang Provincial Hospital of TCM
      • Ningbo, Zhejiang, China, 315000
        • Ningbo First Hospital
      • Ningbo, Zhejiang, China, 315000
        • Ningbo Medical Treatment Center of LiHuiLi Hospital
      • Wenzhou, Zhejiang, China, 325000
        • The Second Hospital Affiliated to Wenzhou Medical College

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 85 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  1. Age≥18 years at screening.
  2. Patients who have ischemia myocardial symptoms and whose clinical symptoms keep stable for at least one month.
  3. Have at least one of the following events (providing hospital records or inspection report): 1)history of acute myocardial infarction for at least half of a year; 2) history of PCI or CABG for at least half of a year; 3) coronary CT angiography or coronary angiography shows that at least one of the main branches of coronary artery stenosis is no less than 50%.
  4. Provide informed consent form.

Exclusion Criteria:

  1. History of acute myocardial infarction, vascular reconstruction, CABG or PCI within half of a year.
  2. Prepared to undertake CABG or PCI during this study.
  3. Serious cardiovascular diseases: sustained severe angina (CCS Ⅳ), refractory heart failure, cardiogenic shock, severe aortic stenosis or aortic insufficiency.
  4. Severe respiratory diseases;
  5. Diabetic patients with poor glycemic control (fasting blood glucose > 200 mg/dl or 11.1mmol/L for more than twice within one month before the study entry).
  6. Hypertensive patients with poor control of blood pressure, systolic pressure≥180mmHg or diastolic pressure≥110mmHg before entry.
  7. Severe liver and kidney diseases,such as active liver disease, cirrhosis and uremia.
  8. Any other severe diseases, such as malignant tumor, severe anemia and severe renal artery stenosis.
  9. Unable or unwilling to sign informed consent form.
  10. Join another trial or has received random allocation of this study within one month before entry.
  11. Pregnant or who were attempting to become pregnant.
  12. Patients who are regarded as not being suitable participants by the study investigators.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Heart-protecting Musk Pill
Patients will get standard treatment for coronary artery disease plus 2 Heart-protecting Musk Pills each time, three times a day by mouth for 24 months
Medicamento: Heart-protecting Musk Pill
Comparador de Placebo: Placebo
Patients will get standard treatment for coronary artery disease plus 2 placebo pills each time, three times a day by mouth for 24 months
Medicamento: Placebo

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
The combined incidence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke
Prazo: 24 months
24 months

Medidas de resultados secundários

Medida de resultado
Prazo
The combined incidence of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina or heart failure, and peripheral revascularization (PCI or CABG)
Prazo: 24 months
24 months

Outras medidas de resultado

Medida de resultado
Prazo
The incidence of adverse event
Prazo: 24 months
24 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Shanghai Hutchison Pharmaceuticals Limited

Investigadores

  • Investigador principal: Junbo Ge, Doctor, Fudan University

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de julho de 2011

Conclusão Primária (Antecipado)

1 de junho de 2015

Conclusão do estudo (Antecipado)

1 de dezembro de 2015

Datas de inscrição no estudo

Enviado pela primeira vez

9 de julho de 2013

Enviado pela primeira vez que atendeu aos critérios de CQ

9 de julho de 2013

Primeira postagem (Estimativa)

12 de julho de 2013

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

19 de dezembro de 2014

Última atualização enviada que atendeu aos critérios de controle de qualidade

17 de dezembro de 2014

Última verificação

1 de dezembro de 2014

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • TG0930BXW

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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