Back to resultsEfficacy and Safety of Wen Xin Granules for the Treatment of Unstable Angina Pectoris
Primary Purpose
Coronary Heart Disease, Unstable Angina, Chinese Herbal Medicine
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Wen Xin granule
Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet
Atorvastatin Calcium
Isosorbide Mononitrate Tab 20 MG
Metoprolol Tartrate Tab 25 MG
Aspirin Enteric-coated Tablets
WXG placebo
Trimetazidine Dihydrochloride Tablets
glyceryl trinitrate
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Heart Disease focused on measuring coronary heart disease, unstable angina, Chinese herbal medicine, Wen Xin granule, traditional Chinese medicine
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Wen Xin granule
WXG placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Major adverse cardiovascular events
Including recurrent angina, acute myocardial infarction, severe arrhythmia, heart failure, and cardiac death.
Secondary Outcome Measures
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).
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.
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.
Full Information
NCT ID
NCT04661709
First Posted
November 23, 2020
Last Updated
January 21, 2021
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators
Special Project of National Traditional Chinese Medicine Clinical Research Base of State Administration of Traditional Chinese Medicine, National Natural Science Foundation of China
1. Study Identification
Unique Protocol Identification Number
NCT04661709
Brief Title
Efficacy and Safety of Wen Xin Granules for the Treatment of Unstable Angina Pectoris
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Anticipated)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators
Special Project of National Traditional Chinese Medicine Clinical Research Base of State Administration of Traditional Chinese Medicine, National Natural Science Foundation of China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease, Unstable Angina, Chinese Herbal Medicine
Keywords
coronary heart disease, unstable angina, Chinese herbal medicine, Wen Xin granule, traditional Chinese medicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
It's a double-blind trial and includes two levels of blinding.
Allocation
Randomized
Enrollment
502 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Wen Xin granule
Arm Type
Experimental
Arm Description
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.
Arm Title
WXG placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Wen Xin granule
Other Intervention Name(s)
WXG
Intervention Description
one dose daily, two times per day.
Intervention Type
Drug
Intervention Name(s)
Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet
Intervention Description
one tablet daily. (for patients who can't use aspirin)
Intervention Type
Drug
Intervention Name(s)
Atorvastatin Calcium
Intervention Description
20 mg tablet, one tablet each night.
Intervention Type
Drug
Intervention Name(s)
Isosorbide Mononitrate Tab 20 MG
Intervention Description
one tablet， twice daily.
Intervention Type
Drug
Intervention Name(s)
Metoprolol Tartrate Tab 25 MG
Intervention Description
12.5 mg or 25 mg, two times daily.
Intervention Type
Drug
Intervention Name(s)
Aspirin Enteric-coated Tablets
Intervention Description
100mg tablet, one tablet daily.
Intervention Type
Drug
Intervention Name(s)
WXG placebo
Intervention Description
one dose daily, two times per day.
Intervention Type
Drug
Intervention Name(s)
Trimetazidine Dihydrochloride Tablets
Intervention Description
20 mg tablet, one tablet three times daily.
Intervention Type
Drug
Intervention Name(s)
glyceryl trinitrate
Intervention Description
be taken when angina pectoris attacks.
Primary Outcome Measure Information:
Title
Major adverse cardiovascular events
Description
Including recurrent angina, acute myocardial infarction, severe arrhythmia, heart failure, and cardiac death.
Time Frame
Record the incidence of major adverse cardiovascular events in one year by follow-up.
Secondary Outcome Measure Information:
Title
The thrombelastograph
Description
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).
Time Frame
Before treatment and at eight weeks after treatment.
Title
TCM symptom scale score
Description
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.
Time Frame
Before treatment, four and eight weeks after treatment.
Title
Seattle angina questionnaire
Description
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.
Time Frame
Before treatment, four and eight weeks after treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Li, M.D.
Phone
+86 13051458913
Email
gamyylj@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Li, M.D.
Organizational Affiliation
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
28807510
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.
Results Reference
background
PubMed Identifier
10632302
Citation
Ambrose JA, Dangas G. Unstable angina: current concepts of pathogenesis and treatment. Arch Intern Med. 2000 Jan 10;160(1):25-37. doi: 10.1001/archinte.160.1.25.
Results Reference
background
PubMed Identifier
25748771
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.
Results Reference
background
PubMed Identifier
22719784
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 Jun 6.
Results Reference
result
PubMed Identifier
26972437
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.
Results Reference
result
PubMed Identifier
34774099
Citation
Tian PP, Wu QJ, Li J, Chen HW, Wu J, Deng YW, Xie ZC, Zhao W, Tan YQ. 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. Trials. 2021 Nov 13;22(1):798. doi: 10.1186/s13063-021-05771-y.
Results Reference
derived
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Efficacy and Safety of Wen Xin Granules for the Treatment of Unstable Angina Pectoris
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