Tongxinluo Capsule for Coronary Microvascular Disease

• Status: Not yet recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the efficacy and safety of Tongxinluo in patients with microvascular angina pectoris. Long-term follow-up of 1 to 5 years will be performed to evaluate the effect of Tongxinluo on long-term adverse cardiovascular events in patients with coronary microvascular disease.

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

Details

• Lead Sponsor: Qilu Hospital of Shandong University

Criteria

Inclusion Criteria:

1. Repeated chest pain attacks with typical exertional angina pectoris or resting angina pectoris attacks;

2. Coronary normal or stenosis < 20%;

3. Ischemic depression in ST segment during resting or exercise;

4. Blood flow reserve (CFR) of the anterior descending coronary artery < 2.0;

5. Subjects or their guardians agreed to participate in this study.

Exclusion Criteria:

1. Previous myocardial infarction or PCI or CABG treatment;

2. A history of heart failure or LVEF < 50%;

3. Severe arrhythmia;

4. Myocarditis, Pericardium Disease, Valvular Disease, or Cardiomyopathy;

5. A history of stroke within half a year;

6. Diabetes difficult to control;

7. Refractory hypertension or hypertension accompanied by left ventricular wall thickness > 12 mm;

8. Familial hypercholesterolemia;

9. Takayasu arteritis, Kawasaki disease or coronary artery malformation;

10. Pregnant or nursing, or having the intention to give birth within one year;

11. Hepatic or renal dysfunction;

12. Other diseases which may cause serious risks to patients;

13. Requiring warfarin anticoagulant therapy; Taking potassium channel opener, CCB, ACEI drugs or traditional Chinese medicines;

14. Allergic to contrast agents or blood products;

15. Patients who participated in clinical research of other drugs within 3 months before being selected.