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

Condition(s) targeted: Coronary Artery Stenosis; Coronary Heart Disease

Intervention: Quick-Acting Heart Reliever (Drug); Isosorbide Dinitrate (Drug); Placebo of Isosorbide Dinitrate (Drug); Aspirin Enteric-coated Tablets (Drug); Placebo of Quick-Acting Heart Reliever (Drug); Aspirin Enteric-coated Tablets (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Official(s) and/or principal investigator(s):
Jie Wang, MD, Study Chair, Affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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.

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: the effective power of angina pectoris

Secondary outcome:

plaque

myocardium blood-supply

the end point of the heart(a composite of cardiovascular events including death, nonfatal myocardial infarction,coronary revascularization, hospitalized unstable angina)

symptoms score

quality of life

MMP-9

SCD40L

VEGF

bFGF

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.

Minimum age: 30 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female subjects 30-75 years of age

- Angina or CAD patient

- Diameter stenosis 50-75% in at least one main coronary artery (Confirmed by coronary

arteriography or coronary CT angiography)

- Not received percutaneous coronary intervention(PCI)

- Heart blood stasis obstruction syndrome according to TCM syndrome differentiation

- Provide written informed consent.

Exclusion Criteria:

- Heart transplant or history of CABG or history of percutaneous transluminal coronary

angioplasty (PTCA) with a drug-eluting stent.

- Left ventricular ejection fraction < 35%

- Acute myocardial infarction within 4 weeks prior to inclusion

- The contractive pressure > 160 mmHg or diastolic pressure >100 mmHg

- Severe valvular heart disease

- Insulin-dependent diabetes mellitus

- Serious heart, lung, liver, kidney and brain or other primary complications

- Mental patients

- Diagnosed or suspected tumor

- Allergic persons

- Pregnant, breastfeeding, or intends to become pregnant during the course of the study

(females only)

- Patients not willing to or not able to give the informed consent to participate in

the study

- The patients who are attending other clinical trial

- The person maybe loss for some reason such as work or life condition according to the

investigator's judgement

Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, Beijing 100053, China

Starting date: April 2012
Last updated: August 3, 2014