Coronary Heart DiseasePhase 4NCT04661709
Efficacy and Safety of Wen Xin Granules for the Treatment of Unstable Angina Pectoris
A Phase 4 study testing Wen Xin granule, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet and Atorvastatin Calcium in people with Coronary Heart Disease and Unstable Angina, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Coronary Heart Disease, Unstable Angina, Chinese Herbal Medicine
- What is being tested?
- Wen Xin granule, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet and Atorvastatin Calcium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 502 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 1 Jun 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Being tested
- Wen Xin granule, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG
- Keywords
- coronary heart disease, unstable angina, Chinese herbal medicine, Wen Xin granule, traditional Chinese medicine
- Medical subject headings
- Coronary Disease, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wen Xin granuleDrug
Also called WXG
one dose daily, two times per day.
Clopidogrel Hydrogen Sulfate 75 MG Oral TabletDrug
one tablet daily. (for patients who can't use aspirin)
Atorvastatin CalciumDrug
20 mg tablet, one tablet each night.
Isosorbide Mononitrate Tab 20 MGDrug
one tablet， twice daily.
Metoprolol Tartrate Tab 25 MGDrug
12.5 mg or 25 mg, two times daily.
Aspirin Enteric-coated TabletsDrug
100mg tablet, one tablet daily.
WXG placeboDrug
one dose daily, two times per day.
Trimetazidine Dihydrochloride TabletsDrug
20 mg tablet, one tablet three times daily.
glyceryl trinitrateDrug
be taken when angina pectoris attacks.
| Study group | Role | What they receive |
|---|---|---|
| Wen Xin granule | Experimental | 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. Receives: Drug: Wen Xin granule; Drug: Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet; Drug: Atorvastatin Calcium; Drug: Isosorbide Mononitrate Tab 20 MG; Drug: Metoprolol Tartrate Tab 25 MG; Drug: Aspirin Enteric-coated Tablets; Drug: Trimetazidine Dihydrochloride Tablets; Drug: glyceryl trinitrate |
| WXG placebo | Placebo comparator | 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. Receives: Drug: Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet; Drug: Atorvastatin Calcium; Drug: Isosorbide Mononitrate Tab 20 MG; Drug: Metoprolol Tartrate Tab 25 MG; Drug: Aspirin Enteric-coated Tablets; Drug: WXG placebo; Drug: Trimetazidine Dihydrochloride Tablets; Drug: glyceryl trinitrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events
Including recurrent angina, acute myocardial infarction, severe arrhythmia, heart failure, and cardiac death.
Measured: Record the incidence of major adverse cardiovascular events in one year by follow-up.
Secondary outcomes (3)
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).
Measured: Before treatment and at eight weeks after treatment.
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.
Measured: Before treatment, four and eight weeks after treatment.
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.
Measured: Before treatment, four and eight weeks after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start1 Mar 2021 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 502 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Special Project of National Traditional Chinese Medicine Clinical Research Base of State Administration of Traditional Chinese Medicine, National Natural Science Foundation of China
- Responsible party
- Principal investigator, Jun Li, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Jun Li, M.D., Study director, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04661709
- Sponsor's protocol ID
- Wenxin granule-20201122
- Status last verified
- Jan 2021
- First submitted
- 23 Nov 2020
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28807510Ambrose 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.
PubMed 10632302Smith 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.
PubMed 25748771Jiang 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.
PubMed 22719784Zhang 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.
PubMed 26972437Tian 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.
PubMed 34774099
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04661709
- Acronym / sponsor ID
- Wenxin granule-20201122
- Keywords
- coronary heart disease, unstable angina, Chinese herbal medicine, Wen Xin granule, traditional Chinese medicine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 502 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Special Project of National Traditional Chinese Medicine Clinical Research Base of State Administration of Traditional Chinese Medicine, National Natural Science Foundation of China
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 10 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Wen Xin granule | Experimental | Drug: Wen Xin granule, Drug: Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Drug: Atorvastatin Calcium, Drug: Isosorbide Mononitrate Tab 20 MG, Drug: Metoprolol Tartrate Tab 25 MG, Drug: Aspirin Enteric-coated Tablets, Drug: Trimetazidine Dihydrochloride Tablets, Drug: glyceryl trinitratePatients 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. |
| WXG placebo | Placebo comparator | Drug: Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Drug: Atorvastatin Calcium, Drug: Isosorbide Mononitrate Tab 20 MG, Drug: Metoprolol Tartrate Tab 25 MG, Drug: Aspirin Enteric-coated Tablets, Drug: WXG placebo, Drug: Trimetazidine Dihydrochloride Tablets, Drug: glyceryl trinitratePatients 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. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wen Xin granuleAlso: WXGone dose daily, two times per day. | Drug | Wen Xin granule |
| Clopidogrel Hydrogen Sulfate 75 MG Oral Tabletone tablet daily. (for patients who can't use aspirin) | Drug | WXG placebo, Wen Xin granule |
| Atorvastatin Calcium20 mg tablet, one tablet each night. | Drug | WXG placebo, Wen Xin granule |
| Isosorbide Mononitrate Tab 20 MGone tablet， twice daily. | Drug | WXG placebo, Wen Xin granule |
| Metoprolol Tartrate Tab 25 MG12.5 mg or 25 mg, two times daily. | Drug | WXG placebo, Wen Xin granule |
| Aspirin Enteric-coated Tablets100mg tablet, one tablet daily. | Drug | WXG placebo, Wen Xin granule |
| WXG placeboone dose daily, two times per day. | Drug | WXG placebo |
| Trimetazidine Dihydrochloride Tablets20 mg tablet, one tablet three times daily. | Drug | WXG placebo, Wen Xin granule |
| glyceryl trinitratebe taken when angina pectoris attacks. | Drug | WXG placebo, Wen Xin granule |
Primary outcome
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.
3 secondary outcomes
The thrombelastograph
Time frame: Before treatment and at eight weeks after treatment.
TCM symptom scale score
Time frame: Before treatment, four and eight weeks after treatment.
Seattle angina questionnaire
Time frame: Before treatment, four and eight weeks after treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- Background: PubMed 28807510Niccoli 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.
- Background: PubMed 10632302Ambrose 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.
- Background: PubMed 25748771Smith 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 publication: PubMed 22719784Jiang 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 publication: PubMed 26972437Zhang 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.
- Derived from this study: PubMed 34774099Tian 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Li, M.D. study director
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Wen Xin granule, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet and Atorvastatin Calcium in people with Coronary Heart Disease and Unstable Angina, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Li, M.D. (+86 13051458913, gamyylj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular events (time frame: Record the incidence of major adverse cardiovascular events in one year by follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04661709, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021; AzTrials last refreshed its copy on 8 Nov 2026.