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

Coronary Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01513070
• Other study ID #: SUXIAOJIUXIN2010
• Status: Completed
• Phase: Phase 4
• First received: January 16, 2012
• Last updated: August 3, 2014
• Start date: April 2012
• Est. completion date: June 2014

Study information

• Verified date: August 2014
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2014
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Coronary Artery Disease
• Coronary Artery Stenosis
• Coronary Disease
• Coronary Heart Disease
• Coronary Stenosis
• Heart Diseases
• Myocardial Ischemia

Intervention

Drug:
• Quick-Acting Heart Reliever
Quick-Acting Heart Reliever,200mg,tid,po. for six months
• Isosorbide Dinitrate
Isosorbide Dinitrate,10mg,tid,po. for six months
• Placebo of Isosorbide Dinitrate
Placebo of Isosorbide Dinitrate,10mg,tid,po. for six months
• Aspirin Enteric-coated Tablets
Aspirin Enteric-coated Tablets,100mg,qd,po. for six months
• Placebo of Quick-Acting Heart Reliever
Placebo of Quick-Acting Heart Reliever,200mg,tid,po. for six months
• Aspirin Enteric-coated Tablets
Aspirin Enteric-coated Tablets,100mg,qd,po. for six months

Locations

Country	Name	City	State
China	Guang'anmen Hospital of China Academy of Chinese Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months	No
Secondary	plaque	Assess the plaque by the coronary CT angiography	6 months	No
Secondary	myocardium blood-supply	Evaluate the myocardium blood-supply by the myocardial perfusion imaging	6 months	No
Secondary	the end point of the heart(a composite of cardiovascular events including death, nonfatal myocardial infarction,coronary revascularization, hospitalized unstable angina)		12 months	No
Secondary	symptoms score		6 months	No
Secondary	quality of life		6 months	No
Secondary	MMP-9		6 months	No
Secondary	SCD40L		6 months	No
Secondary	VEGF		6 months	No
Secondary	bFGF		6 months	No