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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04220372
Other study ID # Tongxinluo and CMVD
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date January 2020
Est. completion date January 2025

Study information

Verified date January 2020
Source Qilu Hospital of Shandong University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date January 2025
Est. primary completion date January 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tongxinluo
Provided by Shijiazhuang Yiling Pharmaceutical CO., LTD
Placebo
Provided by Shijiazhuang Yiling Pharmaceutical CO., LTD

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Qilu Hospital of Shandong University

Outcome

Type Measure Description Time frame Safety issue
Primary Changes of Coronary Flow Reserve 1 year
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