Microvascular Angina Intervention With Compound Danshen Dripping Pill (MAIDS)
ConditionMicrovascular Angina
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age30-75
SponsorQilu Hospital of Shandong University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
with typical symptoms of exertional angina;
coronary CTA or angiography with normal coronary artery or <50% stenosis, or <50% residual coronary stenosis after revascularization;
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);
Transthoracic ultrasound examination of blood in the anterior descending coronary artery before and after intravenous injection of adenosine Flow reserve check CFR<2.5;
Disqualifiers
Less than 30 years old or more than 75 years old;
Have a history of carotid endarterectomy or stent implantation, and have a history of stroke;
Myocarditis, pericardial disease, valvular disease, cardiomyopathy;
Difficult to control diabetes mellitus (fasting blood glucose>7.0 mmol/L);
Trial design
Design model
Parallel
Treatments tested in this trial
Compound Danshen Dropping Pills
DrugDosage of Compound Danshen Dropping Pills: 20 capsules each time, 3 times a day, after meals. The follow-up period was 6 months.
Placebo
Drugplacebo (appearance is the same as Compound Danshen Dropping Pills, main ingredient: starch. Production unit: Tianjin Tasly Co., Ltd.), orally after meals, 3 times a day , 20 capsules each time.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Compound Danshen Dropping PillsExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
The change of the left anterior descending coronary flow reserve (CFR)measured by echocardiography.
the difference of the left anterior descending coronary flow reserve (CFR) measured by ultrasound between the two groups.
Time frame
At the end of 6-month follow-up compared to the baselineSecondary outcomes
1
Number of angina attacks per week.
The differences in the number of angina attacks between the two groups.
Time frame
During 6 months of following up.2
The time of angina pectoris in exercise test.
The differences in the time of angina pectoris in exercise test between the two groups.
Time frame
At the end of 6-month follow-up compared to the baseline.3
The time of ischemic ST segment depression in exercise test.
The differences in the time of ischemic ST segment depression in exercise test between the two groups.
Time frame
At the end of 6-month follow-up compared to the baseline.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov