Tongxinluo Capsule for Coronary Microvascular Disease

The Efficacy and Safety of Tongxinluo Capsule in Patients With Coronary Microvascular Disease

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04220372

Enrollment

100

Registered

2020-01-07

Start date

2020-01-31

Completion date

2025-01-31

Last updated

2020-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Microvascular Disease

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.

Interventions

DRUGTongxinluo

Provided by Shijiazhuang Yiling Pharmaceutical CO., LTD

DRUGPlacebo

Provided by Shijiazhuang Yiling Pharmaceutical CO., LTD

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Changes of Coronary Flow Reserve	1 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026