Pre-trial of Clinical Trial of Traditional Chinese Medicine Treatment for Elderly Patients With Coronary Heart Disease Who Are Still Symptomatic After Optimal Medical Treatment
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Seattle angina questionnaire
研究概览
简要总结
To explore the effectiveness of compound Danshen Dripping Pill and Qishen Yiqi Dripping Pill in the elderly population with coronary heart disease and the safety of multiple medications
详细描述
This study is a prospective, double-blind, randomized controlled clinical trial, which aims to explore the effectiveness and safety of polypharmacy in the elderly population of stable angina patients, and make up for the limitations of clinical treatment. As commonly used traditional Chinese medicine preparations, the efficacy and safety of compound Danshen Dripping Pill and Qishen Yiqi Dripping Pill have been supported by previous studies, providing a solid theoretical basis. The study design adopts scientific and reliable clinical trial methods, and the treatment plan combines Western medicine treatment and traditional Chinese medicine intervention, which has high clinical application value. In the actual clinical treatment, due to the complex medical history of elderly patients, they often have multi-vessel coronary artery lesions, and the treatment tolerance is worse than that of young people, so although they are accompanied by angina pectoris, the treatment methods are relatively limited. This study provides evidence of the efficacy and safety of drugs for the treatment of elderly patients with angina pectoris through the combination of Chinese and Western treatments, which can help make up for the dilemma of limited clinical treatment methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 75 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •75 years old ≤ age < 90 years old, regardless of gender;
- •Patients who meet the diagnostic criteria for angina pectoris, including patients with typical or atypical angina pectoris: discomfort in the anterior region is triggered by physical activity or emotional excitement and can be relieved by rest or taking nitroglycerin.Those who meet two or more of the above characteristics. After receiving conventional Western medicine treatment, the symptoms did not improve significantly or the treatment effect is poor.
- •Meet the diagnostic criteria for multiple coronary artery disease with the number of coronary artery disease being greater than or equal to two (defined as angiographically the right coronary artery, left circumflex artery or left anterior descending artery stenosis rate was greater than 50%), and the patient refused or could not tolerate coronary artery revascularization or one or more coronary arteries still have a stenosis rate of ≥50% after partial revascularization;
- •The patient is in line with the qi stagnation and blood stasis type or qi deficiency and blood stasis type in the TCM syndrome classification. If the results of the two syndrome differentiation are inconsistent, the TCM experts will review the syndrome differentiation, and the syndrome differentiation classification of the TCM experts shall prevail.
- •The patient has good communication skills, can understand and provide relevant information required for the study, and is aware of the research purpose, content, possible risks and expected benefits can be fully provided with relevant information required for this research. Patients and their families voluntarily participated and agreed to sign the informed consent.
排除标准
- •Those who have had acute coronary syndrome within the past month
- •Acute myocardial infarction, acute myocarditis, severe arrhythmia, aortic dissecction, pericarditis, heart failure (NYHA heart function class Ⅲ or IV, EF ≤ 30%), cardiogenic shock in past 3 months or patients with chest tightness and chest pain caused by other diseases such as severe valvular disease, etc.
- •Combined with acute pulmonary embolism, acute cerebral hemorrhage, polyarteritis, severe hematologic diseases, severe infectious diseases, severe immune dysfunction, malignant tumors, other organ failure or expected life expectancy less than 1 year
- •Severe primary disease or severe dysfunction of the liver or kidneys（ALT levels exceeding 3.0 times the upper limit of normal or eGFR ≤30 mL/min/1.73 m²）
- •Patients with severe mental disorder
- •Those who are allergic to the test drug
- •Patients who have participated in other clinical trials in the past month
- •Patients who have taken anticoagulants such as warfarin, new oral anticoagulants (NOAC) or traditional Chinese medicine preparations for promoting blood circulation and removing blood stasis in the past month
- •Refusal to sign informed consent
研究组 & 干预措施
Qi stagnation and blood stasis type control group
Intervention with placebo on the Basis of optimal medical treatment
干预措施: Placebo (Drug)
Qi stagnation and blood stasis type experimental group
Intervention with Compound Danshen Dripping Pills on the Basis of optimal medical treatment
干预措施: Compound Danshen Dripping Pills (Drug)
Qi deficiency and blood stasis type control group
Intervention with placebo on the Basis of optimal medical treatment
干预措施: Placebo (Drug)
Qi deficiency and blood stasis type experimental group
Intervention with Qishen Yiqi Dropping Pills on the basis of conventional western medicine treatment
干预措施: Qishen Yiqi Drop Pills (Drug)
结局指标
主要结局
Seattle angina questionnaire
时间窗: 8 weeks. If the change is not significant, it can be extended to 12 weeks.
The Seattle Angina Questionnaire (SAQ) consists of five distinct dimensions: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. Each dimension is scored independently, with a possible range of 0 to 100 points. A higher score on any SAQ dimension indicates a better patient condition or experience.
The Canadian Cardiovascular Society grading of angina pectoris
时间窗: 8 weeks. If the change is not significant, it can be extended to 12 weeks.
The Canadian Cardiovascular Society grades angina pectoris ranges from grade 1 to grade 4. Higher grade indicates worse patients' condition.
Minnesota Living with Heart Failure Questionnaire
时间窗: 8 weeks. If the change is not significant, it can be extended to 12 weeks.
The Minnesota Living with Heart Failure Questionnaire's score ranges from 0 to 105. Higher score indicates worse patients' condition.
Kansas City Cardiomyopathy Questionnaire
时间窗: 8 weeks. If the change is not significant, it can be extended to 12 weeks.
The Kansas City Cardiomyopathy Questionnaire's score ranges from 0 to 100. Higher score indicates better patients' condition.
次要结局
- Traditional Chinese Medicine Syndrome Score(8 weeks. If the change is not significant, it can be extended to 12 weeks.)
- Number of angina attacks(8 weeks. If the change is not significant, it can be extended to 12 weeks.)
- Nitroglycerin dosage(8 weeks. If the change is not significant, it can be extended to 12 weeks.)