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

January 21, 2021 updated by: Jun Li, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

502

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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 Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Wen Xin granule
Patients are given Wen Xin granule by mouth, one dose daily for 2 months & Conventional western medicine, including Aspirin Enteric-coated Tablets 100mg qd, Clopidogrel Hydrogen Sulfate 75 mg qd, Atorvastatin Calcium 20mg qn, Isosorbide Mononitrate Tab 20 mg bid, Metoprolol Tartrate Tab 25mg, Trimetazidine Dihydrochloride Tablets 20mg tid.
Drug: Wen Xin granule
one dose daily, two times per day.
Other Names:
  • WXG
Drug: Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet
one tablet daily. (for patients who can't use aspirin)
Drug: Atorvastatin Calcium
20 mg tablet, one tablet each night.
Drug: Isosorbide Mononitrate Tab 20 MG
one tablet， twice daily.
Drug: Metoprolol Tartrate Tab 25 MG
12.5 mg or 25 mg, two times daily.
Drug: Aspirin Enteric-coated Tablets
100mg tablet, one tablet daily.
Drug: Trimetazidine Dihydrochloride Tablets
20 mg tablet, one tablet three times daily.
Drug: glyceryl trinitrate
be taken when angina pectoris attacks.
Placebo Comparator: WXG placebo
Patients are given Wen Xin granule placebo by mouth, one dose daily for 2 months & Conventional western medicine, including Aspirin Enteric-coated Tablets 100mg qd, Clopidogrel Hydrogen Sulfate 75 mg qd, Atorvastatin Calcium 20mg qn, Isosorbide Mononitrate Tab 20 mg bid, Metoprolol Tartrate Tab 25mg, Trimetazidine Dihydrochloride Tablets 20mg tid.
Drug: Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet
one tablet daily. (for patients who can't use aspirin)
Drug: Atorvastatin Calcium
20 mg tablet, one tablet each night.
Drug: Isosorbide Mononitrate Tab 20 MG
one tablet， twice daily.
Drug: Metoprolol Tartrate Tab 25 MG
12.5 mg or 25 mg, two times daily.
Drug: Aspirin Enteric-coated Tablets
100mg tablet, one tablet daily.
Drug: Trimetazidine Dihydrochloride Tablets
20 mg tablet, one tablet three times daily.
Drug: glyceryl trinitrate
be taken when angina pectoris attacks.
Drug: WXG placebo
one dose daily, two times per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiovascular events
Time Frame: Record the incidence of major adverse cardiovascular events in one year by follow-up.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The thrombelastograph
Time Frame: Before treatment and at eight weeks after treatment.
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.
TCM symptom scale score
Time Frame: Before treatment, four and eight weeks after treatment.
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.
Seattle angina questionnaire
Time Frame: Before treatment, four and eight weeks after treatment.
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.

Collaborators and Investigators

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

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Collaborators

National Natural Science Foundation of China
Special Project of National Traditional Chinese Medicine Clinical Research Base of State Administration of Traditional Chinese Medicine

Investigators

  • Study Director: Jun Li, M.D., Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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)

March 1, 2021

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

November 23, 2020

First Submitted That Met QC Criteria

December 8, 2020

First Posted (Actual)

December 10, 2020

Study Record Updates

Last Update Posted (Actual)

January 25, 2021

Last Update Submitted That Met QC Criteria

January 21, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Wenxin granule-20201122

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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