Clinical trial NCT05482009: Treatment of Angina Pectoris After Coronary Revascularization With Integrated Traditional Chinese and Western Medicine
Official title: Evidence-based Optimization of Chinese and Western Medicine Differentiation and Treatment Scheme for Angina Pectoris After Coronary Revascularization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Angina Pectoris
Keywords: Integrated Chinese and Western Medicine Treatment
Comprehensive Treatment
Lead sponsor: Jiangsu Famous Medical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-08-01
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in tertiary hospitals

Brief summary: This study used a multicenter, prospective cohort study. According to whether they received TCM treatment and the degree of exposure to TCM, the cohorts were divided into strong TCM exposure group, TCM exposure group, weak TCM exposure group and Western medicine exposure group. The first three groups received traditional Chinese medicine treatment combined with western medicine basic treatment, and the cumulative treatment time of traditional Chinese medicine reached 80%, 30%-79% or 30% of the total course of treatment, respectively. The fourth group received basic western medicine treatment alone. Among them, Chinese medicines (including Chinese patent medicines, Chinese medicine decoctions, Chinese medicine granules, and Chinese medicine injections) have been used and/or taken for a total of 5 months;

Detailed description: The purpose of this study was to observe whether the combination of traditional Chinese medicine intervention on the basis of standardized western medicine treatment could further reduce the incidence of cardiovascular events in patients with angina pectoris after coronary revascularization compared with western medicine treatment, and to conduct objective follow-up. Evaluation of integrated Chinese and Western medicine interventions. Clinical efficacy of angina pectoris after coronary revascularization and characteristic advantages of TCM syndrome improvement.

The trial is a multicenter, prospective clinical cohort study design. It is expected that 2,000 subjects will be included, and they will be divided into 4 groups according to whether they receive Chinese medicine treatment and the degree of exposure to Chinese medicine. One group received only western medicine basic treatment, and the other three groups received Chinese medicine treatment combined with western medicine basic treatment (the difference was that the cumulative treatment time of Chinese medicine reached 80%, 30%-79% or 30% of the total course of treatment, respectively). Among them, Chinese medicines (including Chinese patent medicines, Chinese medicine decoctions, Chinese medicine granules, and Chinese medicine injections) have been used and/or taken for 5 months in total.

The duration of treatment (including follow-up) in this trial was 24 months. Study data were recorded at 0, 3, 6, 9, 12, 15, 18, 21, and 24 months.

Eligibility criteria: Inclusion Criteria:

* ①Age ≥18 years old and ≤85 years old;

  * Patients who have undergone coronary revascularization (including coronary bypass and/or PCI) in the past.

    * Those who participated voluntarily and signed the informed consent form.

Exclusion Criteria:

* ①Incomplete case data, unable to provide original surgical data entry;

  * Patients who meet the diagnostic criteria for coronary heart disease, angina pectoris or myocardial infarction, but have not undergone coronary revascularization or failed surgery;

    * Patients who still need continuous mechanical adjuvant therapy after successful coronary revascularization; ④ Combined with other heart diseases, such as malignant arrhythmia (rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia), or cardiac insufficiency before and after surgery (cardiac function class IV, NYHA class or Killip class), severe cardiopulmonary insufficiency .

      * Those who have a history of hemorrhagic cerebrovascular accident, or a history of ischemic cerebrovascular accident (including TIA) within half a year; ⑥Mental patients or those who may not be able to cooperate with the program requirements and follow-up procedures due to educational level, language barriers and other reasons.

Primary outcomes:
measure: Incidence of MACE
timeFrame: Assess once 24 months after taking medicine
measure: Readmission rate
timeFrame: Assess once 24 months after taking medicine
Secondary outcomes:
measure: Angina attack frequency scale
timeFrame: 3 months
measure: Angina Attack Duration scale
timeFrame: 3 months
measure: Angina Pain scale
timeFrame: 3 months
measure: Nitroglycerin Dosage scale
timeFrame: 3 months
measure: The Seattle angina questionaire
timeFrame: 3 months
measure: NYHA classification
timeFrame: 3 months
measure: Traditional Chinese medicine syndrome rating scale
timeFrame: 3 months
measure: Patient Health Questionaire-9 scale
timeFrame: 3 months
measure: Generalized Anxiety Disorder -7 scale
timeFrame: 3 months
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
state: Liaoning
Study officials:
affiliation: Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
name: Shuai Wang, master
role: PRINCIPAL_INVESTIGATOR
References: