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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jie Wang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT01513070
First received: January 16, 2012
Last updated: August 3, 2014
Last verified: August 2014

January 16, 2012
August 3, 2014
April 2012
July 2012   (final data collection date for primary outcome measure)
the effective power of angina pectoris [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01513070 on ClinicalTrials.gov Archive Site
  • plaque [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Assess the plaque by the coronary CT angiography
  • myocardium blood-supply [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • symptoms score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • MMP-9 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • SCD40L [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • VEGF [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • bFGF [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • plaque [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Assess the plaque by the coronary CT angiography
  • myocardium blood-supply [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • symptoms score and Chinese syndrome [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • MMP-9、SCD40L、VEGF、bFGF [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Coronary Artery Stenosis
  • Coronary Heart Disease
  • Drug: Quick-Acting Heart Reliever
    Quick-Acting Heart Reliever,200mg,tid,po. for six months
    Other Name: Suxiao Jiuxin Pill
  • Drug: Isosorbide Dinitrate
    Isosorbide Dinitrate,10mg,tid,po. for six months
    Other Name: Cedocard,Nitrosorbide, Vascardin
  • 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
  • Drug: Placebo of Quick-Acting Heart Reliever
    Placebo of Quick-Acting Heart Reliever,200mg,tid,po. for six months
  • Experimental: Quick-Acting Heart Reliever group
    Drug: Quick-Acting Heart Reliever and Placebo of isosorbide dinitrate and Aspirin Enteric-coated Tablets
    Interventions:
    • Drug: Quick-Acting Heart Reliever
    • Drug: Placebo of Isosorbide Dinitrate
    • Drug: Aspirin Enteric-coated Tablets
  • Active Comparator: Isosorbide Dinitrate group
    Isosorbide Dinitrate and Placebo of Quick-Acting Heart Reliever and Aspirin Enteric-coated Tablets
    Interventions:
    • Drug: Isosorbide Dinitrate
    • Drug: Placebo of Quick-Acting Heart Reliever
    • Drug: Aspirin Enteric-coated Tablets
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
June 2014
July 2012   (final data collection date for primary outcome measure)

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
Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01513070
SUXIAOJIUXIN2010
No
Jie Wang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Not Provided
Study Chair: Jie Wang, MD Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP