Tongxinluo Capsule for Coronary Microvascular Disease

NCT ID: NCT04220372

Last Updated: 2020-01-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-31
• Study Completion Date: 2025-01-31

Brief 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.

Conditions

Coronary Microvascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Tongxinluo Capsule

Group Type: EXPERIMENTAL

Tongxinluo

Intervention Type: DRUG

Provided by Shijiazhuang Yiling Pharmaceutical CO., LTD

Placebo Capsule

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Provided by Shijiazhuang Yiling Pharmaceutical CO., LTD

Interventions

Tongxinluo

Provided by Shijiazhuang Yiling Pharmaceutical CO., LTD

Intervention Type: DRUG

Placebo

Provided by Shijiazhuang Yiling Pharmaceutical CO., LTD

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Pan-Pan Hao

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Tongxinluo and CMVD

Identifier Type: -

Identifier Source: org_study_id