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

NCT01513070 | Completed Phase 4

• 1 other identifier: SUXIAOJIUXIN2010
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• plaque

  6 months

• myocardium blood-supply

  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

Study Arms (2)

Quick-Acting Heart Reliever group

EXPERIMENTAL

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

Drug: Quick-Acting Heart Reliever; Drug: Placebo of Isosorbide Dinitrate; Drug: Aspirin Enteric-coated Tablets

Isosorbide Dinitrate group

ACTIVE COMPARATOR

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

Drug: Isosorbide Dinitrate; Drug: Placebo of Quick-Acting Heart Reliever; Drug: Aspirin Enteric-coated Tablets

Interventions

Quick-Acting Heart Reliever DRUG

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

Also known as: Suxiao Jiuxin Pill

Quick-Acting Heart Reliever group

Isosorbide Dinitrate DRUG

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

Also known as: Cedocard，Nitrosorbide， Vascardin

Isosorbide Dinitrate group

Placebo of Isosorbide Dinitrate DRUG

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

Quick-Acting Heart Reliever group

Aspirin Enteric-coated Tablets DRUG

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

Quick-Acting Heart Reliever group

Placebo of Quick-Acting Heart Reliever DRUG

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

Isosorbide Dinitrate group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Heart transplant or history of CABG or history of percutaneous transluminal coronary angioplasty (PTCA) with a drug-eluting stent.
• Left ventricular ejection fraction \< 35%
• 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

Sponsors & Collaborators

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

Study Sites (1)

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Coronary Stenosis; Coronary Disease; Angina Pectoris

Interventions

Isosorbide Dinitrate

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Isosorbide; Sorbitol; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Jie Wang, MD

  Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of Guang'anmen Hospital

Study Record Dates

• First Submitted: January 16, 2012
• First Posted: January 20, 2012
• Study Start: April 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: June 1, 2014
• Last Updated: August 5, 2014

Record last verified: 2014-08

Locations

CN (1)