Tongxinluo Capsule for Coronary Microvascular Disease

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Microvascular Disease
• Intervention / Treatment: Drug: Tongxinluo; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Tongxinluo Capsule	Drug: Tongxinluo; Provided by Shijiazhuang Yiling Pharmaceutical CO., LTD
PLACEBO_COMPARATOR: Placebo Capsule	Drug: Placebo; Provided by Shijiazhuang Yiling Pharmaceutical CO., LTD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes of Coronary Flow Reserve	1 year

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2020
• Primary Completion (ANTICIPATED): January 1, 2021
• Study Completion (ANTICIPATED): January 1, 2025

Study Registration Dates

• First Submitted: January 5, 2020
• First Submitted That Met QC Criteria: January 5, 2020
• First Posted (ACTUAL): January 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 7, 2020
• Last Update Submitted That Met QC Criteria: January 5, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Angina Pectoris; Microvascular Angina
• Other Study ID Numbers: Tongxinluo and CMVD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No