Status:
UNKNOWN
A Trial to Evaluate Efficacy of Heart-protecting Musk Pill
Lead Sponsor:
Shanghai Hutchison Pharmaceuticals Limited
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief 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 di...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2015
Estimated Enrollment :
2700 Patients enrolled
Trial Details
Trial ID
NCT01897805
Start Date
July 1 2011
End Date
December 1 2015
Last Update
December 19 2014
Active Locations (98)
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1
AnHui Provincial Hospital
Hefei, Anhui, China, 230000
2
The First Affiliated Hospital of Medical University Of Anhui
Hefei, Anhui, China, 230000
3
MaAnShan Central Hospital
Maanshan, Anhui, China, 243000
4
Beijing An Zhen Hospital of the Capital University of Medical Sciences
Beijing, Beijing Municipality, China, 100000