NCT01513070

A Clinical Trials of Quick-Acting Heart Reliever for Moderate Coronary Stenosis

A Randomized Double-blind Placebo-controlled Clinical Trials of the Blood-quickening Stasis-transforming Formula Quick-Acting Heart Reliever for Patients With Moderate Coronary Stenosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Stenosis
• Coronary Heart Disease

Interventions

Type	Name	Description
DRUG	Quick-Acting Heart Reliever	Quick-Acting Heart Reliever，200mg，tid，po. for six months
DRUG	Isosorbide Dinitrate	Isosorbide Dinitrate，10mg，tid，po. for six months
DRUG	Placebo of Isosorbide Dinitrate	Placebo of Isosorbide Dinitrate，10mg，tid，po. for six months
DRUG	Aspirin Enteric-coated Tablets	Aspirin Enteric-coated Tablets，100mg，qd，po. for six months
DRUG	Placebo of Quick-Acting Heart Reliever	Placebo of Quick-Acting Heart Reliever，200mg，tid，po. for six months
DRUG	Aspirin Enteric-coated Tablets	Aspirin Enteric-coated Tablets，100mg，qd，po. for six months

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-07-01
• Completion: 2014-06-01
• First posted: 2012-01-20
• Last updated: 2014-08-05

Locations

1 site across 1 country: China