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Coronary Artery DiseasePhase 4NCT01897805

A Trial to Evaluate Efficacy of Heart-protecting Musk Pill

A Phase 4 study testing Heart-protecting Musk Pill in people with Coronary Artery Disease, run by Shanghai Hutchison Pharmaceuticals Limited at 98 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
Heart-protecting Musk Pill
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,700 participants
Where
98 sitesChina
Study dates
Jul 2011to Dec 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

98 sites in 1 country.

98 sites in 1 country

China98 sites

  • The First Hospital Of China Medical University

    Anshan, Liaoning, 114000

  • Beijing An Zhen Hospital of the Capital University of Medical Sciences

    Beijing, Beijing Municipality, 100000

  • Beijing Hospital

    Beijing, Beijing Municipality, 100000

  • Beijing Shijitan Hospital

    Beijing, Beijing Municipality, 100000

  • Beijing Tongren Hospital Capital Medical University

    Beijing, Beijing Municipality, 100000

  • Dongfang Hospital Affiliated to Beijing University of Chinese Medicine

    Beijing, Beijing Municipality, 100000

  • Navi General Hospital

    Beijing, Beijing Municipality, 100000

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100000

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin, 160000

  • The First People's Hospital of Changde

    Changde, Hunan, 415000

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410000

  • Xiangya Hospital Central-South University

    Changsha, Hunan, 410000

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610000

  • Armed police Chongqing Corps Hospital

    Chongqing, Chongqing Municipality, 400000

  • The Third People's Hospital of Chongqing

    Chongqing, Chongqing Municipality, 400000

  • The 210th Hospital of Chinese people's Liberation Army

    Dalian, Liaoning, 116000

  • The second people's Hospital of Dalian

    Dalian, Liaoning, 116000

  • DaQing General Hospial Group LongNan Hosptial

    Daqing, Heilongjiang, 163000

  • FuJian Provincial Hospital

    Fuzhou, Fujian, 350000

  • People's Hospital of Fujian Province

    Fuzhou, Fujian, 350000

  • Affiliated Hospital of Guangzhou Medcal College

    Guangzhou, Guangdong, 510000

  • The First Affiliated Hospital of Guangzhou University of Chinese Medicine

    Guangzhou, Guangdong, 510000

  • The First Affiliated Hospital Sun Yat-sen University

    Guangzhou, Guangdong, 510000

  • Hangzhou Traditional Chinese Medical Hospital

    Hangzhou, Zhejiang, 310000

  • The Affiliated Hospital of Hangzhou Normal University

    Hangzhou, Zhejiang, 310000

  • The First Affiliated Hospital ZheJiang University

    Hangzhou, Zhejiang, 310000

  • Tongde Hospital of ZheJiang Province

    Hangzhou, Zhejiang, 310000

  • ZheJiang Hospital

    Hangzhou, Zhejiang, 310000

  • Zhejiang Provincial Hospital of TCM

    Hangzhou, Zhejiang, 310000

  • AnHui Provincial Hospital

    Hefei, Anhui, 230000

  • The First Affiliated Hospital of Medical University Of Anhui

    Hefei, Anhui, 230000

  • The First Affiliated Hospital of University of South China

    Hengyang, Hunan, 421000

  • The People's Hospital of Jiangmen

    Jiangmen, Guangdong, 529000

  • Affiliated Hospital of Shandong University of TCM

    Jinan, Shandong, 250000

  • Shangdong Provincial Hospital

    Jinan, Shandong, 250000

  • KaiFeng Central Hospital

    Kaifeng, Henan, 475000

  • First People's Hospital of Yunnan Province

    Kunming, Yunnan, 650000

  • Yunnan Provincial Hospital of Traditional Chinese Medicine

    Kunming, Yunnan, 650000

  • Linyi People's Hospital

    Linyi, Shandong, 276000

  • The First People's Hospital of Liuzhou City

    Liuzhou, Guangxi, 545000

  • The Affiliated Hospital of Luzhou Medical College

    Luzhou, Sichuan, 646000

  • MaAnShan Central Hospital

    Maanshan, Anhui, 243000

  • The Affiliated Hospital of JiangXi University of Traditional Chinese Medicine

    Nanchang, Jiangxi, 330000

  • The First Hospital of NanChang

    Nanchang, Jiangxi, 330000

  • The Second Affiliated Hospital of NanChang University

    Nanchang, Jiangxi, 330000

  • Affiliated Hospital of Chuanbei Medical College

    Nanchong, Sichuan, 637000

  • JiangSu Province Hosptial of TCM

    Nanjing, Jiangsu, 210000

  • JiangSu Province Hosptial

    Nanjing, Jiangsu, 210000

  • NanJing Drum Tower Hospital The Affiliated Hospital of NanJing University Medical School

    Nanjing, Jiangsu, 210000

  • NanJing First Hospital

    Nanjing, Jiangsu, 210000

  • NanJing Hospital of TCM

    Nanjing, Jiangsu, 210000

  • The First Affiliated Hospital Of GuangXi University Of Chinese Medicine

    Nanning, Guangxi, 530000

  • Ningbo First Hospital

    Ningbo, Zhejiang, 315000

  • Ningbo Medical Treatment Center of LiHuiLi Hospital

    Ningbo, Zhejiang, 315000

  • The Affiliated Hospital of PuTian University

    Putian, Fujian, 351100

  • Qilu Hospital of Shandong University

    Qinan, Shandong, 250000

  • Qingdao University Medical College Affiliated Yuhuangding Hospital

    Qingdao, Shandong, 264000

  • Huadong Hospital Affiliated To Fudan University

    Shanghai, Shanghai Municipality, 200000

  • Huashan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200000

  • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200000

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200000

  • Shanghai First People's Hospital

    Shanghai, Shanghai Municipality, 200000

  • Shuguang Hospital

    Shanghai, Shanghai Municipality, 200000

  • Tongji Hospital Affiliated to Tongji University

    Shanghai, Shanghai Municipality, 200000

  • Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200000

  • Zhongshan hospital Fudan University

    Shanghai, Shanghai Municipality, 200000

  • Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

    Shenyang, Liaoning, 110000

  • The Fourth Affiliated Hospital of China Medical University

    Shenyang, Liaoning, 110000

  • ShenZhen People's Hospital

    Shenzhen, Guangdong, 518000

  • HeBei General Hosital

    Shijiazhuang, Hebei, 050000

  • The Seond Hospital of HeBei Medical University

    Shijiazhuang, Hebei, 050000

  • Taihe Hospital

    Shiyan, Hubei, 442000

  • SuZhou Municipal Hospital

    Suzhou, Jiangsu, 215000

  • Shanxi Medical University First Hospital

    Taiyuan, Shanxi, 030000

  • Shanxi Medical University Second Hospital

    Taiyuan, Shanxi, 030000

  • JiangSu TaiZhou People's Hospital

    Taizhou, Jiangsu, 225300

  • TangShan GongRen Hospital

    Tangshan, Hebei, 063000

  • The First Teaching Hospital of TianJin University of Traditional Chinese Medicine

    Tianjin, Tianjin Municipality, 300000

  • TianHe Hospital

    Tianjin, Tianjin Municipality, 300000

  • TianJin Chest Hospital

    Tianjin, Tianjin Municipality, 300000

  • Tianjin Third Central Hospital

    Tianjin, Tianjin Municipality, 300000

  • The Second Hospital Affiliated to Wenzhou Medical College

    Wenzhou, Zhejiang, 325000

  • Hubei Provincial Corps Hospital of CPAPF

    Wuhan, Hubei, 430000

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430000

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430000

  • WuXi People's Hospital

    Wuxi, Jiangsu, 214000

  • XiaMen Heart Center

    Xiamen, Fujian, 361000

  • Xiangyang Central Hospital

    Xiangyang, Hubei, 441100

  • The Affiliated Hospital of XuZhou Medical College

    Xuzhou, Jiangsu, 221000

  • Northern JiangSu People's Hospital

    Yangzhou, Jiangsu, 225000

  • YangZhou No. 1 People's Hospital

    Yangzhou, Jiangsu, 225000

  • The Affiliated Hospital of Medical College of Qingdao University

    Yantai, Shandong, 266000

  • The Affiliated Hospital of Guangdong Medical College

    Zhanjiang, Guangdong, 524000

  • People's Hospital of Henan Province

    Zhengzhou, Henan, 450000

  • The First Affiliated Hospital of Henan University of TCM

    Zhengzhou, Henan, 450000

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450000

  • The Second Affiliated Hospital of Henan University of TCM

    Zhengzhou, Henan, 450000

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450000

Other trials in China

About this study

Official title: 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

Read more

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.

Being tested
Heart-protecting Musk Pill, Placebo
Keywords
Coronary artery disease
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Heart-protecting Musk PillDrug

  • PlaceboDrug

Study groups in NCT01897805
Study groupRoleWhat they receive
Heart-protecting Musk PillExperimentalPatients 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
Receives: Drug: Heart-protecting Musk Pill
PlaceboPlacebo comparatorPatients will get standard treatment for coronary artery disease plus 2 placebo pills each time, three times a day by mouth for 24 months
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The combined incidence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke

    Measured: 24 months

Secondary outcomes (1)

  1. 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)

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2013 (estimated)
  2. Study startJul 2011
  3. Primary completionJun 2015 (estimated)
  4. Study completionDec 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,700 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01897805
Sponsor's protocol ID
TG0930BXW
Status last verified
Dec 2014
First submitted
9 Jul 2013
Last updated
19 Dec 2014
Results posted
No
Data monitoring committee
No

Publications

  • Shi H, Zhou J, Ma C, Ji F, Wu Y, Zhao Y, Qian J, Wang X. Shexiang Baoxin Pill (MUSKARDIA) reduces major adverse cardiovascular events in women with stable coronary artery disease: A subgroup analysis of a phase IV randomized clinical trial. Front Cardiovasc Med. 2022 Oct 21;9:1002400. doi: 10.3389/fcvm.2022.1002400. eCollection 2022.

    PubMed 36386372

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Heart-protecting Musk Pill in people with Coronary Artery Disease, run by Shanghai Hutchison Pharmaceuticals Limited at 98 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 98 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The combined incidence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01897805, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2014.

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