NCT03072121

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
440

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 7, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

1.5 years

First QC Date

February 22, 2017

Last Update Submit

March 30, 2017

Conditions

Coronary Artery Disease(CAD)

Keywords

coronary artery diseaserevascularizationShexiang Baoxin Pill

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Death caused by cardiovascular disease

    Six months after randomisation

Secondary Outcomes (5)

  • Ejection fraction percentage (EF%)

    At baseline (before randomisation), and six months after randomisation.

  • E/A ratio

    At baseline (before randomisation), and six months after randomisation.

  • C-reactive protein (CRP)

    At baseline(before randomisation), and six months after randomisation.

  • B-type natriuretic peptide (BNP)

    At baseline (before randomisation), and six months after randomisation.

  • Hospital readmission rates

    At baseline (before randomisation), and six months after randomisation.

Study Arms (2)

Shexiang baoxin pill

EXPERIMENTAL

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: Shexiang Baoxin pillDrug: Aspirin Enteric-coated TabletsDrug: Clopidogrel Hydrogen Sulfate 75 MG Oral TabletDrug: Atorvastatin CalciumDrug: Isosorbide Mononitrate Tab 20 MGDrug: Metoprolol Tartrate Tab 25 MGDrug: Trimetazidine Dihydrochloride Tablets

SBP placebo

PLACEBO COMPARATOR

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: SBP placeboDrug: Aspirin Enteric-coated TabletsDrug: Clopidogrel Hydrogen Sulfate 75 MG Oral TabletDrug: Atorvastatin CalciumDrug: Isosorbide Mononitrate Tab 20 MGDrug: Metoprolol Tartrate Tab 25 MGDrug: Trimetazidine Dihydrochloride Tablets

Interventions

Shexiang Baoxin pillDRUG

Conventional western medicine \& shexiang baoxin pill

Also known as: SBP
Shexiang baoxin pill
SBP placeboDRUG

Conventional western medicine \& placebo (for shexiang baoxin pill)

SBP placebo
Aspirin Enteric-coated TabletsDRUG

100mg tablet, one tablet daily.

SBP placeboShexiang baoxin pill
Clopidogrel Hydrogen Sulfate 75 MG Oral TabletDRUG

one tablet daily. (for patients who can't use aspirin)

Also known as: Plavix
SBP placeboShexiang baoxin pill
Atorvastatin CalciumDRUG

10 mg tablet, two tablets each night.

Also known as: Lipitor
SBP placeboShexiang baoxin pill
Isosorbide Mononitrate Tab 20 MGDRUG

1 tablet two times daily.

Also known as: Xinkang
SBP placeboShexiang baoxin pill
Metoprolol Tartrate Tab 25 MGDRUG

12.5 mg or 25 mg two times daily.

Also known as: Metoprolol
SBP placeboShexiang baoxin pill
Trimetazidine Dihydrochloride TabletsDRUG

20 mg tablet, one tablet three times daily.

Also known as: Vasorel
SBP placeboShexiang baoxin pill

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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".

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Zhao D. [Why dentists need to learn the epidemiological status and prevention strategy of coronary heart disease in China]. Zhonghua Kou Qiang Yi Xue Za Zhi. 2016 Jul;51(7):385-6. doi: 10.3760/cma.j.issn.1002-0098.2016.07.001. Chinese.

    PMID: 27480425RESULT

  • Zhu H, Luo XP, Wang LJ. [Evaluation on clinical effect of long-term shexiang baoxin pill administration for treatment of coronary heart disease]. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2010 May;30(5):474-7. Chinese.

    PMID: 20681275RESULT

  • Zhou Z, Shen W, Yu L, Xu C, Wu Q. A Chinese patent medicine, Shexiang Baoxin Pill, for Non-ST-elevation acute coronary syndromes: A systematic review. J Ethnopharmacol. 2016 Dec 24;194:1130-1139. doi: 10.1016/j.jep.2016.11.024. Epub 2016 Nov 12.

    PMID: 27847338RESULT

  • Williams B, Menon M, Satran D, Hayward D, Hodges JS, Burke MN, Johnson RK, Poulose AK, Traverse JH, Henry TD. Patients with coronary artery disease not amenable to traditional revascularization: prevalence and 3-year mortality. Catheter Cardiovasc Interv. 2010 May 1;75(6):886-91. doi: 10.1002/ccd.22431.

    PMID: 20432394RESULT

  • Gupta S, Pressman GS, Morris DL, Figueredo VM. Distribution of left ventricular ejection fraction in angina patients with severe coronary artery disease not amenable to revascularization. Coron Artery Dis. 2010 Aug;21(5):278-80. doi: 10.1097/MCA.0b013e32833bdf53.

    PMID: 20531008RESULT

  • Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.

    PMID: 23303884RESULT

  • Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2011;9(8):672-7. doi: 10.1016/j.ijsu.2011.09.004. Epub 2011 Oct 13. No abstract available.

    PMID: 22019563RESULT

  • Tian PP, Li J, Gao J, Li Y. Efficacy and safety of the Shexiang Baoxin Pill for the treatment of coronary artery disease not amenable to revascularisation: study protocol for a randomised, placebo-controlled, double-blinded trial. BMJ Open. 2018 Feb 14;8(2):e018052. doi: 10.1136/bmjopen-2017-018052.

    PMID: 29444778DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

shexiang baoxinClopidogrelTabletsAtorvastatinisosorbide-5-mononitrateMetoprololTrimetazidine

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDosage FormsPharmaceutical PreparationsPyrrolesAzolesHeptanoic AcidsFatty AcidsLipidsPhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsPropanolsAminesPiperazines

Study Officials

  • Jie Wang, MD

    Guang'anmen Hospital of China Academy of Chinese Medical Sciences

    STUDY DIRECTOR

Central Study Contacts

Jun Li, MD

CONTACT

+86 1305145891313051458913@163.com

Panpan Tian

CONTACT

+86 1565238817515652388175@163.com

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
SPONSOR INVESTIGATOR
PI Title
Director of Cardiology

Study Record Dates

First Submitted

February 22, 2017

First Posted

March 7, 2017

Study Start

June 1, 2017

Primary Completion

December 1, 2018

Study Completion

February 1, 2019

Last Updated

April 4, 2017

Record last verified: 2017-03