NCT06092736 Microvascular Angina Intervention With Compound Danshen Dripping Pill (MAIDS)
| NCT ID | NCT06092736 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Qilu Hospital of Shandong University |
| Condition | Microvascular Angina |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2018-12-18 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2018-12-18 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Yun Zhang, PhD
PRINCIPAL INVESTIGATOR
Qilu Hospital of Shandong University
Frequently Asked Questions
Who can join the NCT06092736 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 75 Years, studying Microvascular Angina. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06092736 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06092736 currently recruiting?
Yes, NCT06092736 is actively recruiting participants. Contact the research team at zhangyun@sdu.edu.cn for enrollment information.
Where is the NCT06092736 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT06092736 clinical trial?
NCT06092736 is sponsored by Qilu Hospital of Shandong University. The principal investigator is Yun Zhang, PhD at Qilu Hospital of Shandong University. The trial plans to enroll 100 participants.