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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Heart Disease; Coronary Artery Stenosis
• Intervention / Treatment: Drug: Quick-Acting Heart Reliever; Drug: Placebo of Isosorbide Dinitrate; Drug: Aspirin Enteric-coated Tablets; Drug: Isosorbide Dinitrate; Drug: Placebo of Quick-Acting Heart Reliever

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Quick-Acting Heart Reliever group; Drug: Quick-Acting Heart Reliever and Placebo of isosorbide dinitrate and Aspirin Enteric-coated Tablets	Drug: Quick-Acting Heart Reliever; Quick-Acting Heart Reliever，200mg，tid，po. for six months; Other Names: Suxiao Jiuxin Pill; 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
Active Comparator: Isosorbide Dinitrate group; Isosorbide Dinitrate and Placebo of Quick-Acting Heart Reliever and Aspirin Enteric-coated Tablets	Drug: Aspirin Enteric-coated Tablets; Aspirin Enteric-coated Tablets，100mg，qd，po. for six months; Drug: Isosorbide Dinitrate; Isosorbide Dinitrate，10mg，tid，po. for six months; Other Names: Cedocard，Nitrosorbide， Vascardin; Drug: Placebo of Quick-Acting Heart Reliever; Placebo of Quick-Acting Heart Reliever，200mg，tid，po. for six months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
plaque	Assess the plaque by the coronary CT angiography	6 months
myocardium blood-supply	Evaluate the myocardium blood-supply by the myocardial perfusion imaging	6 months
the end point of the heart(a composite of cardiovascular events including death, nonfatal myocardial infarction,coronary revascularization, hospitalized unstable angina)		12 months
symptoms score		6 months
quality of life		6 months
MMP-9		6 months
SCD40L		6 months
VEGF		6 months
bFGF		6 months

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Investigators: Study Chair: Jie WANG, MD, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: January 16, 2012
• First Submitted That Met QC Criteria: January 19, 2012
• First Posted (Estimate): January 20, 2012

Study Record Updates

• Last Update Posted (Estimate): August 5, 2014
• Last Update Submitted That Met QC Criteria: August 3, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Myocardial Perfusion Imaging; Traditional Chinese Medicine; Clinical Trial; Coronary Heart Disease; Isosorbide Dinitrate; Chinese Medicine; Angina Pectoris; Coronary Artery Stenosis; Quick-Acting Heart Reliever; Suxiao Jiuxin Pill; Chinese Herbal Drugs
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Constriction, Pathologic; Coronary Stenosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Natriuretic Agents; Diuretics, Osmotic; Diuretics; Nitric Oxide Donors; Aspirin; Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate
• Other Study ID Numbers: SUXIAOJIUXIN2010