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
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Drug: Heart-protecting Musk Pill
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Shanghai Hutchison Pharmaceuticals Limited:

Primary Outcome Measures:
  • The combined incidence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • The incidence of adverse event [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2700
Study Start Date: July 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01897805

  Show 98 Study Locations
Sponsors and Collaborators
Shanghai Hutchison Pharmaceuticals Limited
Investigators
Principal Investigator: Junbo Ge, Doctor Fudan University
  More Information

No publications provided

Responsible Party: Shanghai Hutchison Pharmaceuticals Limited
ClinicalTrials.gov Identifier: NCT01897805     History of Changes
Other Study ID Numbers: TG0930BXW
Study First Received: July 9, 2013
Last Updated: July 12, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Shanghai Hutchison Pharmaceuticals Limited:
Coronary artery disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014