A Trial to Evaluate Efficacy of Heart-protecting Musk Pill

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Shanghai Hutchison Pharmaceuticals Limited
ClinicalTrials.gov Identifier:
NCT01897805
First received: July 9, 2013
Last updated: July 12, 2013
Last verified: July 2013

July 9, 2013
July 12, 2013
July 2011
June 2015   (final data collection date for primary outcome measure)
The combined incidence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01897805 on ClinicalTrials.gov Archive Site
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) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
The incidence of adverse event [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Same as current
 
A Trial to Evaluate Efficacy of Heart-protecting Musk Pill
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Coronary Artery Disease
  • Drug: Heart-protecting Musk Pill
  • Drug: Placebo
  • 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
    Intervention: Drug: Heart-protecting Musk Pill
  • Placebo Comparator: 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
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2700
December 2015
June 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01897805
TG0930BXW
No
Shanghai Hutchison Pharmaceuticals Limited
Shanghai Hutchison Pharmaceuticals Limited
Not Provided
Principal Investigator: Junbo Ge, Doctor Fudan University
Shanghai Hutchison Pharmaceuticals Limited
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP