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

Primary Purpose

Coronary Artery Stenosis, Coronary Heart Disease

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Quick-Acting Heart Reliever
Isosorbide Dinitrate
Placebo of Isosorbide Dinitrate
Aspirin Enteric-coated Tablets
Placebo of Quick-Acting Heart Reliever
Aspirin Enteric-coated Tablets
Sponsored by
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Stenosis focused on measuring Quick-Acting Heart Reliever, Coronary Artery Stenosis, Coronary Heart Disease, Suxiao Jiuxin Pill, Chinese Herbal Drugs, Traditional Chinese Medicine, Chinese Medicine, Angina Pectoris, Isosorbide Dinitrate, Myocardial Perfusion Imaging, Clinical Trial

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Quick-Acting Heart Reliever group

Isosorbide Dinitrate group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

plaque
Assess the plaque by the coronary CT angiography
myocardium blood-supply
Evaluate the myocardium blood-supply by the myocardial perfusion imaging
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

Full Information

First Posted
January 16, 2012
Last Updated
August 3, 2014
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01513070
Brief Title
A Clinical Trials of Quick-Acting Heart Reliever for Moderate Coronary Stenosis
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 Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Stenosis, Coronary Heart Disease
Keywords
Quick-Acting Heart Reliever, Coronary Artery Stenosis, Coronary Heart Disease, Suxiao Jiuxin Pill, Chinese Herbal Drugs, Traditional Chinese Medicine, Chinese Medicine, Angina Pectoris, Isosorbide Dinitrate, Myocardial Perfusion Imaging, Clinical Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Quick-Acting Heart Reliever group
Arm Type
Experimental
Arm Description
Drug: Quick-Acting Heart Reliever and Placebo of isosorbide dinitrate and Aspirin Enteric-coated Tablets
Arm Title
Isosorbide Dinitrate group
Arm Type
Active Comparator
Arm Description
Isosorbide Dinitrate and Placebo of Quick-Acting Heart Reliever and Aspirin Enteric-coated Tablets
Intervention Type
Drug
Intervention Name(s)
Quick-Acting Heart Reliever
Other Intervention Name(s)
Suxiao Jiuxin Pill
Intervention Description
Quick-Acting Heart Reliever，200mg，tid，po. for six months
Intervention Type
Drug
Intervention Name(s)
Isosorbide Dinitrate
Other Intervention Name(s)
Cedocard，Nitrosorbide， Vascardin
Intervention Description
Isosorbide Dinitrate，10mg，tid，po. for six months
Intervention Type
Drug
Intervention Name(s)
Placebo of Isosorbide Dinitrate
Intervention Description
Placebo of Isosorbide Dinitrate，10mg，tid，po. for six months
Intervention Type
Drug
Intervention Name(s)
Aspirin Enteric-coated Tablets
Intervention Description
Aspirin Enteric-coated Tablets，100mg，qd，po. for six months
Intervention Type
Drug
Intervention Name(s)
Placebo of Quick-Acting Heart Reliever
Intervention Description
Placebo of Quick-Acting Heart Reliever，200mg，tid，po. for six months
Intervention Type
Drug
Intervention Name(s)
Aspirin Enteric-coated Tablets
Intervention Description
Aspirin Enteric-coated Tablets，100mg，qd，po. for six months
Primary Outcome Measure Information:
Title
the effective power of angina pectoris
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
plaque
Description
Assess the plaque by the coronary CT angiography
Time Frame
6 months
Title
myocardium blood-supply
Description
Evaluate the myocardium blood-supply by the myocardial perfusion imaging
Time Frame
6 months
Title
the end point of the heart(a composite of cardiovascular events including death, nonfatal myocardial infarction,coronary revascularization, hospitalized unstable angina)
Time Frame
12 months
Title
symptoms score
Time Frame
6 months
Title
quality of life
Time Frame
6 months
Title
MMP-9
Time Frame
6 months
Title
SCD40L
Time Frame
6 months
Title
VEGF
Time Frame
6 months
Title
bFGF
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie Wang, MD
Organizational Affiliation
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China

12. IPD Sharing Statement

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

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