A Trial to Evaluate Efficacy of Heart-protecting Musk Pill
17. prosince 2014 aktualizováno: 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.
Přehled studie
Postavení
Neznámý
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Očekávaný)
2700
Fáze
- Fáze 4
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
Anhui
-
Hefei, Anhui, Čína, 230000
- Anhui Provincial Hospital
-
Hefei, Anhui, Čína, 230000
- The First Affiliated Hospital of Medical University Of Anhui
-
Maanshan, Anhui, Čína, 243000
- MaAnShan Central Hospital
-
-
Beijing
-
Beijing, Beijing, Čína, 100000
- Beijing An Zhen Hospital of the Capital University of Medical Sciences
-
Beijing, Beijing, Čína, 100000
- Beijing Hospital
-
Beijing, Beijing, Čína, 100000
- Beijing Shijitan Hospital
-
Beijing, Beijing, Čína, 100000
- Beijing Tongren Hospital Capital Medical University
-
Beijing, Beijing, Čína, 100000
- Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
-
Beijing, Beijing, Čína, 100000
- Navi General Hospital
-
Beijing, Beijing, Čína, 100000
- Peking University First Hospital
-
-
Chongqing
-
Chongqing, Chongqing, Čína, 400000
- Armed police Chongqing Corps Hospital
-
Chongqing, Chongqing, Čína, 400000
- The Third People's Hospital of Chongqing
-
-
Fujian
-
Fuzhou, Fujian, Čína, 350000
- Fujian Provincial Hospital
-
Fuzhou, Fujian, Čína, 350000
- People's Hospital of Fujian Province
-
Putian, Fujian, Čína, 351100
- The Affiliated Hospital of Putian University
-
Xiamen, Fujian, Čína, 361000
- Xiamen Heart Center
-
-
Guangdong
-
Guangzhou, Guangdong, Čína, 510000
- Affiliated Hospital of Guangzhou Medcal College
-
Guangzhou, Guangdong, Čína, 510000
- The First Affiliated Hospital of Guangzhou University of Chinese Medicine
-
Guangzhou, Guangdong, Čína, 510000
- The First Affiliated Hospital Sun Yat-Sen University
-
Jiangmen, Guangdong, Čína, 529000
- The People's Hospital of Jiangmen
-
Shenzhen, Guangdong, Čína, 518000
- ShenZhen People's Hospital
-
Zhanjiang, Guangdong, Čína, 524000
- The Affiliated Hospital of Guangdong Medical College
-
-
Guangxi
-
Liuzhou, Guangxi, Čína, 545000
- The First People's Hospital of Liuzhou City
-
Nanning, Guangxi, Čína, 530000
- The First Affiliated Hospital of Guangxi University of Chinese Medicine
-
-
Hebei
-
Shijiazhuang, Hebei, Čína, 050000
- HeBei General Hosital
-
Shijiazhuang, Hebei, Čína, 050000
- The Seond Hospital of HeBei Medical University
-
Tangshan, Hebei, Čína, 063000
- Tangshan Gongren Hospital
-
-
Heilongjiang
-
Daqing, Heilongjiang, Čína, 163000
- DaQing General Hospial Group LongNan Hosptial
-
-
Henan
-
Kaifeng, Henan, Čína, 475000
- Kaifeng Central Hospital
-
Zhengzhou, Henan, Čína, 450000
- The first affiliated hospital of Zhengzhou university
-
Zhengzhou, Henan, Čína, 450000
- People's Hospital of Henan Province
-
Zhengzhou, Henan, Čína, 450000
- The first affiliated hospital of henan university of TCM
-
Zhengzhou, Henan, Čína, 450000
- The Second Affiliated Hospital of Henan University of TCM
-
Zhengzhou, Henan, Čína, 450000
- The Second Affiliated Hospital of Zhengzhou University
-
-
Hubei
-
Shiyan, Hubei, Čína, 442000
- Taihe Hospital
-
Wuhan, Hubei, Čína, 430000
- Renmin Hospital of Wuhan University
-
Wuhan, Hubei, Čína, 430000
- Zhongnan Hospital of Wuhan University
-
Wuhan, Hubei, Čína, 430000
- Hubei Provincial Corps Hospital of CPAPF
-
Xiangyang, Hubei, Čína, 441100
- Xiangyang Central Hospital
-
-
Hunan
-
Changde, Hunan, Čína, 415000
- The First People's Hospital of Changde
-
Changsha, Hunan, Čína, 410000
- The second Xiangya hospital of central south university
-
Changsha, Hunan, Čína, 410000
- Xiangya Hospital Central-South University
-
Hengyang, Hunan, Čína, 421000
- The First Affiliated Hospital of University of South China
-
-
Jiangsu
-
Nanjing, Jiangsu, Čína, 210000
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
-
Nanjing, Jiangsu, Čína, 210000
- JiangSu Province Hosptial of TCM
-
Nanjing, Jiangsu, Čína, 210000
- JiangSu Province Hosptial
-
Nanjing, Jiangsu, Čína, 210000
- Nanjing First Hospital
-
Nanjing, Jiangsu, Čína, 210000
- NanJing Hospital of TCM
-
Suzhou, Jiangsu, Čína, 215000
- Suzhou Municipal Hospital
-
Taizhou, Jiangsu, Čína, 225300
- Jiangsu Taizhou People's Hospital
-
Wuxi, Jiangsu, Čína, 214000
- Wuxi People's Hospital
-
Xuzhou, Jiangsu, Čína, 221000
- The Affiliated Hospital of Xuzhou Medical College
-
Yangzhou, Jiangsu, Čína, 225000
- Northern Jiangsu People's Hospital
-
Yangzhou, Jiangsu, Čína, 225000
- YangZhou No. 1 People's Hospital
-
-
Jiangxi
-
Nanchang, Jiangxi, Čína, 330000
- The Second Affiliated Hospital of Nanchang University
-
Nanchang, Jiangxi, Čína, 330000
- The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
-
Nanchang, Jiangxi, Čína, 330000
- The First Hospital of Nanchang
-
-
Jilin
-
Changchun, Jilin, Čína, 160000
- China-Japan Union Hospital of Jilin University
-
-
Liaoning
-
Anshan, Liaoning, Čína, 114000
- The First Hospital of China Medical University
-
Dalian, Liaoning, Čína, 116000
- The 210th Hospital of Chinese people's Liberation Army
-
Dalian, Liaoning, Čína, 116000
- The second people's Hospital of Dalian
-
Shenyang, Liaoning, Čína, 110000
- Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
-
Shenyang, Liaoning, Čína, 110000
- The fourth Affiliated Hospital of China Medical University
-
-
Shandong
-
Jinan, Shandong, Čína, 250000
- Affiliated Hospital of Shandong University of TCM
-
Jinan, Shandong, Čína, 250000
- Shangdong Provincial Hospital
-
Linyi, Shandong, Čína, 276000
- Linyi People's Hospital
-
Qinan, Shandong, Čína, 250000
- Qilu Hospital of Shandong University
-
Qingdao, Shandong, Čína, 264000
- Qingdao University Medical College Affiliated Yuhuangding Hospital
-
Yantai, Shandong, Čína, 266000
- The Affiliated Hospital of Medical College of Qingdao University
-
-
Shanghai
-
Shanghai, Shanghai, Čína, 200000
- Huadong Hospital Affiliated to Fudan University
-
Shanghai, Shanghai, Čína, 200000
- Huashan Hospital Fudan University
-
Shanghai, Shanghai, Čína, 200000
- Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
-
Shanghai, Shanghai, Čína, 200000
- Shanghai East Hospital
-
Shanghai, Shanghai, Čína, 200000
- Shanghai First People's Hospital
-
Shanghai, Shanghai, Čína, 200000
- ShuGuang Hospital
-
Shanghai, Shanghai, Čína, 200000
- Tongji Hospital Affiliated to Tongji University
-
Shanghai, Shanghai, Čína, 200000
- Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
-
Shanghai, Shanghai, Čína, 200000
- Zhongshan Hospital Fudan University
-
-
Shanxi
-
Taiyuan, Shanxi, Čína, 030000
- Shanxi Medical University First Hospital
-
Taiyuan, Shanxi, Čína, 030000
- Shanxi Medical University Second Hospital
-
-
Sichuan
-
Chengdu, Sichuan, Čína, 610000
- Sichuan Provincial People's Hospital
-
Luzhou, Sichuan, Čína, 646000
- The Affiliated Hospital of Luzhou Medical College
-
Nanchong, Sichuan, Čína, 637000
- Affiliated Hospital of Chuanbei Medical College
-
-
Tianjin
-
Tianjin, Tianjin, Čína, 300000
- The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
-
Tianjin, Tianjin, Čína, 300000
- TianHe Hospital
-
Tianjin, Tianjin, Čína, 300000
- Tianjin Chest Hospital
-
Tianjin, Tianjin, Čína, 300000
- Tianjin Third Central Hospital
-
-
Yunnan
-
Kunming, Yunnan, Čína, 650000
- First People's Hospital of Yunnan Province
-
Kunming, Yunnan, Čína, 650000
- Yunnan Provincial Hospital of Traditional Chinese Medicine
-
-
Zhejiang
-
Hangzhou, Zhejiang, Čína, 310000
- The Affiliated Hospital of Hangzhou Normal University
-
Hangzhou, Zhejiang, Čína, 310000
- Hangzhou Traditional Chinese Medical Hospital
-
Hangzhou, Zhejiang, Čína, 310000
- The First Affiliated Hospital Zhejiang University
-
Hangzhou, Zhejiang, Čína, 310000
- Tongde Hospital of Zhejiang Province
-
Hangzhou, Zhejiang, Čína, 310000
- Zhejiang Hospital
-
Hangzhou, Zhejiang, Čína, 310000
- Zhejiang Provincial Hospital of TCM
-
Ningbo, Zhejiang, Čína, 315000
- Ningbo First Hospital
-
Ningbo, Zhejiang, Čína, 315000
- Ningbo Medical Treatment Center of LiHuiLi Hospital
-
Wenzhou, Zhejiang, Čína, 325000
- The Second Hospital Affiliated to Wenzhou Medical College
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 85 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Age≥18 years at screening.
- Patients who have ischemia myocardial symptoms and whose clinical symptoms keep stable for at least one month.
- 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%.
- Provide informed consent form.
Exclusion Criteria:
- History of acute myocardial infarction, vascular reconstruction, CABG or PCI within half of a year.
- Prepared to undertake CABG or PCI during this study.
- Serious cardiovascular diseases: sustained severe angina (CCS Ⅳ), refractory heart failure, cardiogenic shock, severe aortic stenosis or aortic insufficiency.
- Severe respiratory diseases;
- 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).
- Hypertensive patients with poor control of blood pressure, systolic pressure≥180mmHg or diastolic pressure≥110mmHg before entry.
- Severe liver and kidney diseases,such as active liver disease, cirrhosis and uremia.
- Any other severe diseases, such as malignant tumor, severe anemia and severe renal artery stenosis.
- Unable or unwilling to sign informed consent form.
- Join another trial or has received random allocation of this study within one month before entry.
- Pregnant or who were attempting to become pregnant.
- Patients who are regarded as not being suitable participants by the study investigators.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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
|
|
|
Komparátor placeba: 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
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
The combined incidence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke
Časové okno: 24 months
|
24 months
|
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
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)
Časové okno: 24 months
|
24 months
|
Další výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
The incidence of adverse event
Časové okno: 24 months
|
24 months
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Junbo Ge, Doctor, Fudan University
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. července 2011
Primární dokončení (Očekávaný)
1. června 2015
Dokončení studie (Očekávaný)
1. prosince 2015
Termíny zápisu do studia
První předloženo
9. července 2013
První předloženo, které splnilo kritéria kontroly kvality
9. července 2013
První zveřejněno (Odhad)
12. července 2013
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
19. prosince 2014
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
17. prosince 2014
Naposledy ověřeno
1. prosince 2014
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- TG0930BXW
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .