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

This study is currently recruiting participants.
Verified January 2012 by Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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: January 27, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Coronary Artery Stenosis
Coronary Heart Disease
 Drug: Quick-Acting Heart Reliever
Drug: Isosorbide Dinitrate
Drug: Placebo of Isosorbide Dinitrate
Drug: Aspirin Enteric-coated Tablets
Drug: Placebo of Quick-Acting Heart Reliever
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Guang'anmen Hospital of China Academy of Chinese Medical Sciences:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: April 2010
Estimated Study Completion Date: August 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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: Isosorbide Dinitrate
Isosorbide Dinitrate，10mg，tid，po. for six months
Other Name: Cedocard，Nitrosorbide， Vascardin
Drug: Placebo of Quick-Acting Heart Reliever
Placebo of Quick-Acting Heart Reliever，200mg，tid，po. for six months
Drug: Aspirin Enteric-coated Tablets
Aspirin Enteric-coated Tablets，100mg，qd，po. for six months

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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01513070

Contacts
Contact: Shuli Wang, MD (86)13581654785 wangshuli990523@126.com

Locations
China, Beijing
Guang'anmen Hospital of China Academy of Chinese Medical Sciences Recruiting
Beijing, Beijing, China, 100053
Contact: Jie Wang, MD     8610-88001381     wangshuli990523@126.com    
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Jie Wang, President of Guang'anmen Hospital, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT01513070     History of Changes
Other Study ID Numbers: SUXIAOJIUXIN2010
Study First Received: January 16, 2012
Last Updated: January 27, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
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

Additional relevant MeSH terms:
Constriction, Pathologic
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Coronary Stenosis
Pathological Conditions, Anatomical
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Isosorbide Dinitrate
Isosorbide-5-mononitrate
Isosorbide
 Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents

ClinicalTrials.gov processed this record on May 16, 2013