Curative Effect Evaluation of Shexiang Baoxin Pill on Coronary Artery Disease Not Amenable to Revascularization

March 30, 2017 updated by: Jun Li

Study of Curative Effect Evaluation of Shexiang Baoxin Pill on Coronary Artery Disease Not Amenable to Revascularization on the Basis of Western Medicine Therapy

The purpose of this study is to determine whether Shexiang Baoxin Pill is effective in the treatment of coronary artery disease not amenable to revascularization on the basis of western medicine therapy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The western medicine treatment for CAD not amenable to revascularization is limited. Shexiang Baoxin Pill, a kind of Chinese patent medicine has been used for treating coronary artery disease in clinical practice in China for many years.

Shexiang baoxin pill(SBP) is applicable to "Qi deficiency and blood stasis syndrome" in traditional Chinese medicine. Recent experimental research has indicated that SBP can improve myocardial ischemia and promote therapeutic angiogenesis.

Study Type

Interventional

Enrollment (Anticipated)

440

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants are aged between 45 and 75 years, diagnosed with sever CAD through coronary arteriography which shows that the left main coronary artery and three-vessel have sever diffuse stenosis, calcification or vascular ectasia, be in accordance with Traditional Chinese Medicine syndrome of "Qi deficiency and blood stasis syndrome" or "phlegm and stasis mu-tual obstruction syndrome".

Exclusion Criteria:

  • Patients with severe valvular disease, congenital cardiomyopathy decompensation
  • Patients with CAD complicated with severe multiple organ disease such as severe heart failure, severe lung, liver or renal dysfunction, peptic ulcer in active stage, or intracranial hemorrhage
  • Patients that use high-dose steroids due to connective tissue disease
  • Patients with serious infections
  • Patients with malignant tumor
  • Patients with hematopoietic diseases
  • Pregnant or lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Shexiang baoxin pill
Shexiang baoxin 22.5mg pill by mouth,2 pills three times daily for 6 months & Conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)
Drug: Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet
one tablet daily. (for patients who can't use aspirin)
Other Names:
  • Plavix
Drug: Aspirin Enteric-coated Tablets
100mg tablet, one tablet daily.
Drug: Trimetazidine Dihydrochloride Tablets
20 mg tablet, one tablet three times daily.
Other Names:
  • Vasorel
Drug: Metoprolol Tartrate Tab 25 MG
12.5 mg or 25 mg two times daily.
Other Names:
  • Metoprolol
Drug: Shexiang Baoxin pill
Conventional western medicine & shexiang baoxin pill
Other Names:
  • SBP
Drug: Atorvastatin Calcium
10 mg tablet, two tablets each night.
Other Names:
  • Lipitor
Drug: Isosorbide Mononitrate Tab 20 MG
1 tablet two times daily.
Other Names:
  • Xinkang
PLACEBO_COMPARATOR: SBP placebo
Placebo shexiang baoxin 22.5mg pill by mouth,2 pills three times daily for 6 months & Conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)
Drug: Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet
one tablet daily. (for patients who can't use aspirin)
Other Names:
  • Plavix
Drug: Aspirin Enteric-coated Tablets
100mg tablet, one tablet daily.
Drug: Trimetazidine Dihydrochloride Tablets
20 mg tablet, one tablet three times daily.
Other Names:
  • Vasorel
Drug: Metoprolol Tartrate Tab 25 MG
12.5 mg or 25 mg two times daily.
Other Names:
  • Metoprolol
Drug: Atorvastatin Calcium
10 mg tablet, two tablets each night.
Other Names:
  • Lipitor
Drug: Isosorbide Mononitrate Tab 20 MG
1 tablet two times daily.
Other Names:
  • Xinkang
Drug: SBP placebo
Conventional western medicine & placebo (for shexiang baoxin pill)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: Six months after randomisation
Death caused by cardiovascular disease
Six months after randomisation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
B-type natriuretic peptide (BNP)
Time Frame: At baseline (before randomisation), and six months after randomisation.
BNP in pg/mL
At baseline (before randomisation), and six months after randomisation.
Hospital readmission rates
Time Frame: At baseline (before randomisation), and six months after randomisation.
Hospital readmission rates due to coronary artery disease during treatment
At baseline (before randomisation), and six months after randomisation.
Ejection fraction percentage (EF%)
Time Frame: At baseline (before randomisation), and six months after randomisation.
One of the Echocardiographic parameters
At baseline (before randomisation), and six months after randomisation.
E/A ratio
Time Frame: At baseline (before randomisation), and six months after randomisation.
One of the Echocardiographic parameters
At baseline (before randomisation), and six months after randomisation.
C-reactive protein (CRP)
Time Frame: At baseline(before randomisation), and six months after randomisation.
CRP in μg/L
At baseline(before randomisation), and six months after randomisation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jun Li

Collaborators

Shanghai Hutchison Pharmaceuticals Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2017

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

February 1, 2019

Study Registration Dates

First Submitted

February 22, 2017

First Submitted That Met QC Criteria

March 1, 2017

First Posted (ACTUAL)

March 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 4, 2017

Last Update Submitted That Met QC Criteria

March 30, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBP-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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