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
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Microvascular Disease
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.
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
No
Studies a U.S. FDA-regulated Device Product
No
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
No
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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