Clinical trial NCT04661709: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Heart Disease
Unstable Angina
Chinese Herbal Medicine
Keywords: coronary heart disease
unstable angina
Chinese herbal medicine
Wen Xin granule
traditional Chinese medicine
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Special Project of National Traditional Chinese Medicine Clinical Research Base of State Administration of Traditional Chinese Medicine
name: National Natural Science Foundation of China
First posted: 2020-12-10
Enrollment: 502
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Major adverse cardiovascular events
timeFrame: Record the incidence of major adverse cardiovascular events in one year by follow-up.
Secondary outcomes:
measure: The thrombelastograph
timeFrame: Before treatment and at eight weeks after treatment.
measure: TCM symptom scale score
timeFrame: Before treatment, four and eight weeks after treatment.
measure: Seattle angina questionnaire
timeFrame: Before treatment, four and eight weeks after treatment.
Other outcomes:
Locations:
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Jun Li, M.D.
role: STUDY_DIRECTOR
References:
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.
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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.
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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.
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.