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A Trial to Evaluate Efficacy of Heart-protecting Musk Pill

17 décembre 2014 mis à jour par: 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.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Anticipé)

2700

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 85 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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
Médicament: Heart-protecting Musk Pill
Comparateur 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
Médicament: Placebo

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
The combined incidence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke
Délai: 24 months
24 months

Mesures de résultats secondaires

Mesure des résultats
Délai
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)
Délai: 24 months
24 months

Autres mesures de résultats

Mesure des résultats
Délai
The incidence of adverse event
Délai: 24 months
24 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Shanghai Hutchison Pharmaceuticals Limited

Les enquêteurs

  • Chercheur principal: Junbo Ge, Doctor, Fudan University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 juillet 2011

Achèvement primaire (Anticipé)

1 juin 2015

Achèvement de l'étude (Anticipé)

1 décembre 2015

Dates d'inscription aux études

Première soumission

9 juillet 2013

Première soumission répondant aux critères de contrôle qualité

9 juillet 2013

Première publication (Estimation)

12 juillet 2013

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

19 décembre 2014

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 décembre 2014

Dernière vérification

1 décembre 2014

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • TG0930BXW

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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