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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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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

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Coronary Artery Stenosis Coronary Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Quick-Acting Heart Reliever group

Drug: Quick-Acting Heart Reliever and Placebo of isosorbide dinitrate and Aspirin Enteric-coated Tablets

Group Type EXPERIMENTAL

Quick-Acting Heart Reliever

Intervention Type DRUG

Quick-Acting Heart Reliever，200mg，tid，po. for six months

Placebo of Isosorbide Dinitrate

Intervention Type DRUG

Placebo of Isosorbide Dinitrate，10mg，tid，po. for six months

Aspirin Enteric-coated Tablets

Intervention Type DRUG

Aspirin Enteric-coated Tablets，100mg，qd，po. for six months

Isosorbide Dinitrate group

Isosorbide Dinitrate and Placebo of Quick-Acting Heart Reliever and Aspirin Enteric-coated Tablets

Group Type ACTIVE_COMPARATOR

Isosorbide Dinitrate

Intervention Type DRUG

Isosorbide Dinitrate，10mg，tid，po. for six months

Placebo of Quick-Acting Heart Reliever

Intervention Type DRUG

Placebo of Quick-Acting Heart Reliever，200mg，tid，po. for six months

Aspirin Enteric-coated Tablets

Intervention Type DRUG

Aspirin Enteric-coated Tablets，100mg，qd，po. for six months

Interventions

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Quick-Acting Heart Reliever

Quick-Acting Heart Reliever，200mg，tid，po. for six months

Intervention Type DRUG

Isosorbide Dinitrate

Isosorbide Dinitrate，10mg，tid，po. for six months

Intervention Type DRUG

Placebo of Isosorbide Dinitrate

Placebo of Isosorbide Dinitrate，10mg，tid，po. for six months

Intervention Type DRUG

Aspirin Enteric-coated Tablets

Aspirin Enteric-coated Tablets，100mg，qd，po. for six months

Intervention Type DRUG

Placebo of Quick-Acting Heart Reliever

Placebo of Quick-Acting Heart Reliever，200mg，tid，po. for six months

Intervention Type DRUG

Aspirin Enteric-coated Tablets

Aspirin Enteric-coated Tablets，100mg，qd，po. for six months

Intervention Type DRUG

Other Intervention Names

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Suxiao Jiuxin Pill Cedocard，Nitrosorbide， Vascardin

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No