Efficacy and Safety of Wen Xin Granules for the Treatment of Unstable Angina Pectoris

Coronary Heart Disease Clinical Trial

Official title:

Efficacy and Safety of Chinese Herbal Medicine Wen Xin Granules for the Treatment of Unstable Angina Pectoris With Yang Deficiency and Blood Stasis Syndrome: Study Protocol for a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04661709
• Other study ID #: Wenxin granule-20201122
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 1, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: January 2021
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Jun Li, M.D.
• Phone: +86 13051458913
• Email: gamyylj[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a double-blind, randomized placebo-controlled trial which aims to evaluate the efficacy and safety of Wen Xin granule in patients with unstable angina pectoris.

Description:

Coronary heart disease has remained the leading cause of death worldwide over the past decades. Unstable angina is a clinical syndrome intermediate in severity between stable angina and acute myocardial infarction with high morbidity and mortality. Standard drug therapy and invasive revascularization are effective in decreasing progression to infarction, reducing symptoms and multiple hospitalizations, in most cases without a decrease in the long-term mortality rate. However, there are still many patients with persistence or recurrence of angina despite standard medical therapy and/or revascularization. Wen Xin granule, as a Chinese herbal medicine has shown great effect in patients with unstable angina in our clinical. However, there is still insufficient evidence on his specific efficacy and safety. Therefor, we'd like to evaluate the efficacy and safety of Wen Xin granule in patients with unstable angina through this multi-center, double-blind, randomized placebo-controlled trial.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 502
• Est. completion date: June 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

Inclusion Criteria:

• aged between 35 and 75 years of age;
• diagnosed with CAD through coronary arteriography, clinically diagnosed with UAP in low or medium risk;
• belong to Yang deficiency and blood stasis syndrome according to TCM, and give written informed consent.
• For the diagnostic criteria of UAP, the investigators will refer to 2014 AHA/ACC Guidelines for the Diagnosis and Management of Non-ST-Elevation Acute Coronary Syndromes.
• For the TCM diagnostic criteria, the investigators will refer to Guidelines for Clinical Research into New Traditional Chinese Medicine Drugs for Chest Obstruction (2002 edition).

Exclusion Criteria:

• chest pain caused by congenital heart diseases, valvular heart disease, severe neurosis, or arrhythmia
• with New York Heart Association class III or IV heart failure, in acute phase of cerebral infarction;
• with uncontrolled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >95 mmHg in the resting state)
• with uncontrolled hyperglycemia or diabetic complications, with mental and neurological abnormalities or dysgnosia;
• female patients in pregnancy or lactation;
• by participating in other clinical trials.

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Unstable
• Chinese Herbal Medicine
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia
• Unstable Angina

Intervention

Drug:
• Wen Xin granule
one dose daily, two times per day.
• Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet
one tablet daily. (for patients who can't use aspirin)
• Atorvastatin Calcium
20 mg tablet, one tablet each night.
• Isosorbide Mononitrate Tab 20 MG
one tablet, twice daily.
• Metoprolol Tartrate Tab 25 MG
12.5 mg or 25 mg, two times daily.
• Aspirin Enteric-coated Tablets
100mg tablet, one tablet daily.
• WXG placebo
one dose daily, two times per day.
• Trimetazidine Dihydrochloride Tablets
20 mg tablet, one tablet three times daily.
• glyceryl trinitrate
be taken when angina pectoris attacks.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences	National Natural Science Foundation of China, Special Project of National Traditional Chinese Medicine Clinical Research Base of State Administration of Traditional Chinese Medicine

References & Publications (5)

Ambrose JA, Dangas G. Unstable angina: current concepts of pathogenesis and treatment. Arch Intern Med. 2000 Jan 10;160(1):25-37. Review. — View Citation

Jiang M, Zhang C, Zheng G, Guo H, Li L, Yang J, Lu C, Jia W, Lu A. Traditional chinese medicine zheng in the era of evidence-based medicine: a literature analysis. Evid Based Complement Alternat Med. 2012;2012:409568. doi: 10.1155/2012/409568. Epub 2012 J — View Citation

Niccoli G, Montone RA, Lanza GA, Crea F. Angina after percutaneous coronary intervention: The need for precision medicine. Int J Cardiol. 2017 Dec 1;248:14-19. doi: 10.1016/j.ijcard.2017.07.105. Epub 2017 Aug 12. Review. — View Citation

Smith JN, Negrelli JM, Manek MB, Hawes EM, Viera AJ. Diagnosis and management of acute coronary syndrome: an evidence-based update. J Am Board Fam Med. 2015 Mar-Apr;28(2):283-93. doi: 10.3122/jabfm.2015.02.140189. Review. — View Citation

Zhang HJ, Wang ZX. Yin-yang and Zheng: Exported from Chinese medicine. Chin J Integr Med. 2014 Apr;20(4):250-5. doi: 10.1007/s11655-014-1777-z. Epub 2014 Apr 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiovascular events	Including recurrent angina, acute myocardial infarction, severe arrhythmia, heart failure, and cardiac death.	Record the incidence of major adverse cardiovascular events in one year by follow-up.
Secondary	The thrombelastograph	Parameters assessed by were R (represent clotting time), K and Angle (reflect clot strength and development), MA (maximum platelet-fibrin clot strength), CI (represents overall coagulability), and LY30 (represents lysis).	Before treatment and at eight weeks after treatment.
Secondary	TCM symptom scale score	TCM syndrome scale includes items of chest tightness, chest pain, heavy body, obesity, phlegm, dark complexion, tongue condition and pulse condition. The chest tightness and chest pain, have 4-grade options of none, mild, moderate and severe, marked as 0, 2, 4 and 6 respectively. The other items have two options of yes or no, marked as 0 and 1 respectively. The higher scores mean more serious symptoms.	Before treatment, four and eight weeks after treatment.
Secondary	Seattle angina questionnaire	The SAQ regroups 19 items measuring five specific scales: physical limitations, anginal stability, anginal frequency, treatment satisfaction and disease perception targeting a specific disease and treatment group. Higher scores mean a better outcome.	Before treatment, four and eight weeks after treatment.