A Phase 4 interventional study of Quick-Acting Heart Reliever and Isosorbide Dinitrate in Coronary Artery Stenosis and Coronary Heart Disease, sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences. Completed at 1 site in China. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-08-05.
Sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Phase 4, Interventional, and Treatment
This study investigates the effective power of angina pectoris after Quick-Acting Heart Reliever and isosorbide dinitrate interventing respectively the patients with moderate coronary stenosis for six months. At the same time, the studying will assess the plaque, myocardial blood-supplying,quality of life and observe the end point of the heart (including the myocardial revascularization, death and myocardial infarction). The purpose is to study the function of the blood-quickening stasis-transforming formula Quick-Acting Heart Reliever for moderate coronary stenosis lesions.
Blood-quickening stasis-transforming medicinal of Chinese medicinal can ameliorate clinical symptoms of coronary artery disease. Quick-Acting Heart Reliever is one of blood-quickening stasis-transforming medicinals to relieve angina pectoris in clinic and is especially benefit for the patients with moderate coronary stenosis who need not coronary revascularization only have medical treatment. But there is no randomized evidence that established the beneficial effects of blood-quickening stasis-transforming medicinals to treat moderate coronary stenosis lesions. This study is a randomized double-blind placebo-controlled clinical trials. A total of 120 consecutive participants with at least one moderate coronary stenosis lesion (diameter stenosis 50-75%) will be randomized to two groups: group 1(n =60) will receive Quick-Acting Heart and the placebo of isosorbide dinitrate, patients in group 2(n = 60) will receive isosorbide dinitrate and the placebo of Quick-Acting Heart for six months. The myocardial perfusion imaging and the coronary CT angiography will be used to evaluate the effective power of angina pectoris,myocardial blood-supplying，the quality and volume of the plaque, diameter stenosis after treating after 6 months and the end point of the heart (including death，myocardial infarction and myocardial revascularization which includes intracoronary stenting and coronary artery bypass grafting,) after 12 months. The purpose is to study the function of Quick-Acting Heart Reliever delaying percutaneous coronary intervention(PCI) for moderate coronary stenosis.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's planned enrollment of 120 is above the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
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Drug: Quick-Acting Heart Reliever and Placebo of isosorbide dinitrate and Aspirin Enteric-coated Tablets
Drug: Quick-Acting Heart Reliever · Drug: Placebo of Isosorbide Dinitrate · Drug: Aspirin Enteric-coated Tablets
Isosorbide Dinitrate and Placebo of Quick-Acting Heart Reliever and Aspirin Enteric-coated Tablets
Drug: Isosorbide Dinitrate · Drug: Placebo of Quick-Acting Heart Reliever · Drug: Aspirin Enteric-coated Tablets
Quick-Acting Heart Reliever，200mg，tid，po. for six months
Also known as: Suxiao Jiuxin Pill
Isosorbide Dinitrate，10mg，tid，po. for six months
Also known as: Cedocard，Nitrosorbide， Vascardin
Placebo of Isosorbide Dinitrate，10mg，tid，po. for six months
Aspirin Enteric-coated Tablets，100mg，qd，po. for six months
Placebo of Quick-Acting Heart Reliever，200mg，tid，po. for six months
Aspirin Enteric-coated Tablets，100mg，qd，po. for six months
the effective power of angina pectoris
the effective power of angina pectoris after Quick-Acting Heart Reliever and isosorbide dinitrate interventing respectively the patients with morderate coronary stenosis for six months
Time frame: 6 months
plaque
Assess the plaque by the coronary CT angiography
Time frame: 6 months
myocardium blood-supply
Evaluate the myocardium blood-supply by the myocardial perfusion imaging
Time frame: 6 months
the end point of the heart(a composite of cardiovascular events including death, nonfatal myocardial infarction,coronary revascularization, hospitalized unstable angina)
Time frame: 12 months
symptoms score
Time frame: 6 months
quality of life
Time frame: 6 months
MMP-9
Time frame: 6 months
SCD40L
Time frame: 6 months
VEGF
Time frame: 6 months
bFGF
Time frame: 6 months
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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Guang'anmen Hospital of China Academy of Chinese Medical Sciences