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

Coronary Artery Disease(CAD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03072121
• Other study ID #: SBP-2016
• Status: Not yet recruiting
• Phase: Phase 4
• First received: February 22, 2017
• Last updated: March 30, 2017
• Start date: June 2017
• Est. completion date: February 2019

Study information

• Verified date: March 2017
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Jun Li, MD
• Phone: +86 13051458913
• Email: 13051458913[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 440
• Est. completion date: February 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease(CAD)
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Shexiang Baoxin pill
Conventional western medicine & shexiang baoxin pill
• SBP placebo
Conventional western medicine & placebo (for shexiang baoxin pill)
• Aspirin Enteric-coated Tablets
100mg tablet, one tablet daily.
• Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet
one tablet daily. (for patients who can't use aspirin)
• Atorvastatin Calcium
10 mg tablet, two tablets each night.
• Isosorbide Mononitrate Tab 20 MG
1 tablet two times daily.
• Metoprolol Tartrate Tab 25 MG
12.5 mg or 25 mg two times daily.
• Trimetazidine Dihydrochloride Tablets
20 mg tablet, one tablet three times daily.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Jun Li	Shanghai Hutchison Pharmaceuticals Limited

References & Publications (7)

Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hróbjartsson 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 — View Citation

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.0b013e328 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Death caused by cardiovascular disease	Six months after randomisation
Secondary	Ejection fraction percentage (EF%)	One of the Echocardiographic parameters	At baseline (before randomisation), and six months after randomisation.
Secondary	E/A ratio	One of the Echocardiographic parameters	At baseline (before randomisation), and six months after randomisation.
Secondary	C-reactive protein (CRP)	CRP in µg/L	At baseline(before randomisation), and six months after randomisation.
Secondary	B-type natriuretic peptide (BNP)	BNP in pg/mL	At baseline (before randomisation), and six months after randomisation.
Secondary	Hospital readmission rates	Hospital readmission rates due to coronary artery disease during treatment	At baseline (before randomisation), and six months after randomisation.