A Clinical Trials of Quick-Acting Heart Reliever for Moderate Coronary Stenosis
Condition: Coronary Artery Stenosis; Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Coronary Stenosis; Constriction, Pathologic
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Quick-Acting Heart Reliever; Isosorbide Dinitrate; Placebo of Isosorbide Dinitrate; Aspirin Enteric-coated Tablets; Placebo of Quick-Acting Heart Reliever; Aspirin Enteric-coated Tablets
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Quick-Acting Heart Reliever，200mg，tid，po. for six months; Isosorbide Dinitrate，10mg，tid，po. for six months; 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
Other intervention name(s): Suxiao Jiuxin Pill; Cedocard，Nitrosorbide， Vascardin
Intervention MeSH terms: Aspirin; Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Quick-Acting Heart Reliever; Coronary Artery Stenosis; Coronary Heart Disease; Suxiao Jiuxin Pill; Chinese Herbal Drugs; Traditional Chinese Medicine; Chinese Medicine; Angina Pectoris; Isosorbide Dinitrate; Myocardial Perfusion Imaging; Clinical Trial