Microvascular Angina Intervention With Compound Danshen Dripping Pill (MAIDS)

• Status: Recruiting
• Trial end date: 2028-06-30
• Target enrollment: 0
• Participant gender: All

Summary

Coronary microvascular disease (MVD) refers to exertional angina or myocardial ischemia caused by abnormal structure and/or function of precoronary arterioles and arterioles under the action of various pathogenic factors. The symptoms of patients with coronary microvascular disease are mainly exertion-related chest pain episodes.

The basic and clinical researches of the traditional Chinese medicine compound Danshen dropping pills have found that it can improve vascular endothelial function and relieve angina pectoris, and it is widely used in clinical practice.

This is a randomized, double-blind, placebo-controlled, multicenter clinical study of Compound Danshen Dropping Pills and blank control in patients with microvascular angina pectoris.

The experimental drug and control drug of this clinical trial were selected according to the ratio of 1:1 patients were enrolled in the pre-experiment.

After the selected patients signed the informed consent, they were divided into a compound Danshen dripping pill treatment group and a placebo group according to a random, double-blind, placebo-controlled method. Dosage of Compound Danshen Dropping Pills or placebo: 20 capsules each time, 3 times a day, for a total of 6 months. Follow-up was performed every 2 months for a total of 6 months.

Primary study endpoints is the difference of the left anterior descending coronary flow reserve (CFR) measured by ultrasound between the two groups compared with the baseline.

Secondary study endpoint include the Number of angina attacks per week, the time of angina pectoris and the time of ischemic ST segment depression in exercise test.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Qilu Hospital of Shandong University

Criteria

Inclusion criteria:

1. with typical symptoms of exertional angina;

2. coronary CTA or angiography with normal coronary artery or <50% stenosis, or <50% residual coronary stenosis after revascularization;

3. resting electrocardiogram or During exercise stress, it was found that the ST segment had an ischemic downward shift (the horizontal or downward slope after the J-point shift > 0.1 mv, lasting 0.08 s);

4. Transthoracic ultrasound examination of blood in the anterior descending coronary artery before and after intravenous injection of adenosine Flow reserve check CFR<2.5;

5. The patient himself agrees to participate in this study.

Exclusion criteria

1. Less than 30 years old or more than 75 years old;

2. Have a history of carotid endarterectomy or stent implantation, and have a history of stroke;

3. Myocarditis, pericardial disease, valvular disease, cardiomyopathy;

4. Difficult to control diabetes mellitus (fasting blood glucose>7.0 mmol/L);

5. Uncontrolled hypertension (SBP>150 mmHg and/or DBP>90 mmHg);

6. Familial hypercholesterolemia;

7. Multiple Takayasu arteritis;

8. Those who are pregnant or lactating, or have fertility intention within one year, or have not taken effective contraceptive measures during the childbearing period;

9. Abnormal liver function (the level of serum GPT is 3.0 times higher than the upper limit of normal value) or abnormal renal function (the level of serum creatinine is more than 2 mg/dl);

10. Other respiratory, digestive, blood, infection, immunity, endocrine, neuropsychiatric, tumor diseases with clinical significance that may cause serious danger to patients;

11. Taking traditional Chinese medicine preparations of K channel opener, promoting blood circulation and removing blood stasis to improve microcirculation;

12. Allergies to intra arterial injection of contrast agents, blood and blood products;

13. Patients who are participating in other clinical studies.