Condition category
Circulatory System
Date applied
03/12/2019
Date assigned
05/02/2020
Last edited
05/02/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Hypertension (high blood pressure) and coronary artery disease (CAD) are increasingly common. Having these conditions means a person is more likely to suffer a heart attack or stroke. In addition, 3 in 10 patients with CAD suffer from depression. Hypertension and CAD are linked to damage to blood vessels and the blood vessels then start to lose the ability to function normally.
Xinkeshu, a traditional Chinese medicine containing herbs, has been proven to reduce blood pressure, improve CAD symptoms and improve depression and anxiety. This study aims to investigate whether Xinkeshu can protect blood vessels in patients with CAD and hypertension, and also whether it can improve symptoms of depression and anxiety.

Who can participate?
Patients aged 18-65 years with CAD and hypertension

What does the study involve?
Participants will be randomly allocated to one of two groups. One group will receive usual treatment for hypertension and CAD (aspirin, atorvastatin and amlodipine). The other group will receive the usual treatment and Xinkeshu tablets. Both groups will take the treatment for 12 weeks. They will have blood samples taken, will have their blood vessels examined using a blood pressure measuring device and ultrasound, and will fill in questionnaires about symptoms of depression and anxiety before they start the treatment and at 4 week s and 12 weeks after the start of treatment.

What are the possible benefits and risks of participating?
Participants will get XKS pills for free to treat their CAD and hypertension. The usual treatment medicines are commonly used and generally safe.

Where is the study run from?
The First Affiliated Hospital, Sun Yat-Sen University (China)

When is the study starting and how long is it expected to run for?
July 2017 to September 2020

Who is funding the study?
Shandong Wohua Pharmaceutical Technology Co Ltd (China)

Who is the main contact?
Jun Tao, taojungz123@163.com

Trial website

Contact information

Type

Public

Primary contact

Dr Jiapan Sun

ORCID ID

Contact details

Department of Hypertension and Vascular Disease
The First Affiliated Hospital
Sun Yat-sen University
No.58
Zhongshan Road 2
Guangzhou
510000
China
15622122042
sunjp3@mail3.sysu.edu.cn

Type

Scientific

Additional contact

Prof Jun Tao

ORCID ID

http://orcid.org/0000-0002-2226-765X

Contact details

Department of Hypertension and Vascular Disease
The First Affiliated Hospital

Sun Yat-sen University

58 Zhongshan Road 2

Guangzhou
Guangdong
Guangzhou
510000
China
-
taojungz123@163.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

2017154

Study information

Scientific title

The protective effect of Xinkeshu tablets on vascular function in patients with coronary artery disease combined with hypertension: a randomized controlled study.

Acronym

X-CHRCS

Study hypothesis

Xinkeshu tablets have a protective effect on vascular endothelium by improving endothelial progenitor cells function and accelerating vascular repair in patients with coronary artery disease combine with hypertension through the CXCR4/JAK2 signaling pathway.

Ethics approval

Approved 15/08/2017, Ethics Committee of Clinical Research and Experimental Animals, The First Affiliated Hospital, Sun Yat-Sen University in Guangzhou (58 Zhongshan Road 2,
 Guangzhou, Guangdong, 510000, China; +86 020-87755766; linf7@mail.sysu.edu.cn), ref: 2017[154]

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available.

Condition

Coronary heart disease combined with hypertension and vascular dysfunction

Intervention

We will recruit 68 patients with hypertension and coronary artery disease who had been admitted to The First Affiliated Hospital, Sun Yat-Sen University. Patients will be randomly divided into XKS group (34) and control group (34). The XKS group will receive routine treatment (aspirin 100 mg qd, atorvastatin 20 mg qd, amlodipine 5 mg qd) combined with Xinkeshu tablets (Shandong Wohua Pharmaceutical Co Ltd), 4 tablets, three times a day for 3 months. The control group will receive routine treatment for 3 months. At the first day, the end of 1st, 2nd and 3rd month, blood samples will be collected, their arterial function will be assessed, and any anxiety and depressive symptoms will be evaluated. The blood sample tests include endothelial microparticles (EMPs), endothelial progenitor cells (EPCs), liver function, kidney function, blood lipid, blood glucose and so on. Arterial function examination includes artery flow-mediated dilation (FMD) and brachial-ankle pulse wave velocity (baPWV). Anxiety and depressive symptoms would be evaluated by using GAD-7 and PHQ-9 score.The patients need to provide their peripheral blood to get their endothelial progenitor cells.

Intervention type

Drug

Phase

Not Applicable

Drug names

Xinkeshu tablets

Primary outcome measure

1. Brachial arterial flow-mediated dilation measured using ultrasound at baseline, 4 weeks and 12 weeks
2. Brachial-ankle pulse wave velocity measured using a blood pressure measuring device at baseline, 4 weeks and 12 weeks
3. Anxiety assessed using the GAD-7 questionnaire at baseline, 4 weeks and 12 weeks
4. Depression assessed using the PHQ-9 questionnaire at baseline, 4 weeks and 12 weeks

Secondary outcome measures

1. Endothelial microparticles measured using flow cytometry of peripheral blood samples taken at baseline, 4 weeks and 12 weeks
2. Quantity of endothelial progenitor cells measured using flow cytometry of peripheral blood samples taken at baseline, 4 weeks and 12 weeks
3. Blood pressure measured using a tronic sphygmomanometer (HEM-7071, OMRON, China) at baseline, 4 weeks and 12 weeks

Overall trial start date

01/07/2017

Overall trial end date

01/09/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18-70 years
2. Diagnosed with hypertension and coronary artery disease and have received regular coronary heart disease secondary prevention drugs and antihypertensive drugs
3. Baseline GAD-7 and PHQ-9 score were both between 5-14 points
4. Have given written informed consent prior to study participation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant exclusion criteria

1. Severe liver or kidney dysfunction or malignant tumors
2. Allergic to any component of Xinkeshu tablet
3. Cardiovascular or cerebrovascular accident within previous 3 months
4. Pregnant or lactating women

Recruitment start date

01/12/2019

Recruitment end date

30/06/2020

Locations

Countries of recruitment

China

Trial participating centre

First Affiliated Hospital, Sun Yat-sen University
Department of Hypertension and Cardiovascular Disease, First Affiliated Hospital, Sun Yat-sen University No.58, Zhongshan Road 2
Guangzhou
510000
China

Sponsor information

Organisation

Shandong Wohua Pharmaceutical Co Ltd

Sponsor details

3517 Liyuan street
Weifang High-tech Industrial Development Zone
Shandong province
Weifang
261021
China
+86 15101008647
yanlong@ccpi.net.cn

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Shandong Wohua Pharmaceutical Co Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We intend to publish in one of the SCI journals in 2020 after finishing the study.

IPD sharing statement:
The datasets generated and/or analysed during this study will be included in the subsequent results publication

Intention to publish date

31/12/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

21/01/2020: Trial's existence confirmed by Ethics Committee of the First Affiliated Hospital of Sun Yat-sen University.