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Tongxinluo Capsule for Coronary Microvascular Disease

Primary Purpose

Coronary Microvascular Disease

Status

Not yet recruiting

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Tongxinluo

Placebo

About this trial

This is an interventional treatment trial for Coronary Microvascular Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Repeated chest pain attacks with typical exertional angina pectoris or resting angina pectoris attacks;
Coronary normal or stenosis < 20%;
Ischemic depression in ST segment during resting or exercise;
Blood flow reserve (CFR) of the anterior descending coronary artery < 2.0;
Subjects or their guardians agreed to participate in this study.

Exclusion Criteria:

Previous myocardial infarction or PCI or CABG treatment;
A history of heart failure or LVEF < 50%;
Severe arrhythmia;
Myocarditis, Pericardium Disease, Valvular Disease, or Cardiomyopathy;
A history of stroke within half a year;
Diabetes difficult to control;
Refractory hypertension or hypertension accompanied by left ventricular wall thickness > 12 mm;
Familial hypercholesterolemia;
Takayasu arteritis, Kawasaki disease or coronary artery malformation;
Pregnant or nursing, or having the intention to give birth within one year;
Hepatic or renal dysfunction;
Other diseases which may cause serious risks to patients;
Requiring warfarin anticoagulant therapy; Taking potassium channel opener, CCB, ACEI drugs or traditional Chinese medicines;
Allergic to contrast agents or blood products;
Patients who participated in clinical research of other drugs within 3 months before being selected.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tongxinluo Capsule

Placebo Capsule

Arm Description

Outcomes

Primary Outcome Measures

Changes of Coronary Flow Reserve

Secondary Outcome Measures

Full Information

NCT ID

NCT04220372

First Posted

January 5, 2020

Last Updated

January 5, 2020

Sponsor

Qilu Hospital of Shandong University

1. Study Identification

Unique Protocol Identification Number

NCT04220372

Brief Title

Tongxinluo Capsule for Coronary Microvascular Disease

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 2020 (Anticipated)

Primary Completion Date

January 2021 (Anticipated)

Study Completion Date

January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Qilu Hospital of Shandong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Microvascular Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tongxinluo Capsule

Arm Type

Experimental

Arm Title

Placebo Capsule

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Tongxinluo

Intervention Description

Provided by Shijiazhuang Yiling Pharmaceutical CO., LTD

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Provided by Shijiazhuang Yiling Pharmaceutical CO., LTD

Primary Outcome Measure Information:

Title

Changes of Coronary Flow Reserve

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Repeated chest pain attacks with typical exertional angina pectoris or resting angina pectoris attacks; Coronary normal or stenosis < 20%; Ischemic depression in ST segment during resting or exercise; Blood flow reserve (CFR) of the anterior descending coronary artery < 2.0; Subjects or their guardians agreed to participate in this study. Exclusion Criteria: Previous myocardial infarction or PCI or CABG treatment; A history of heart failure or LVEF < 50%; Severe arrhythmia; Myocarditis, Pericardium Disease, Valvular Disease, or Cardiomyopathy; A history of stroke within half a year; Diabetes difficult to control; Refractory hypertension or hypertension accompanied by left ventricular wall thickness > 12 mm; Familial hypercholesterolemia; Takayasu arteritis, Kawasaki disease or coronary artery malformation; Pregnant or nursing, or having the intention to give birth within one year; Hepatic or renal dysfunction; Other diseases which may cause serious risks to patients; Requiring warfarin anticoagulant therapy; Taking potassium channel opener, CCB, ACEI drugs or traditional Chinese medicines; Allergic to contrast agents or blood products; Patients who participated in clinical research of other drugs within 3 months before being selected.

12. IPD Sharing Statement

Learn more about this trial

Tongxinluo Capsule for Coronary Microvascular Disease

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