Tongxinluo Capsule for Coronary Microvascular Disease
The Efficacy and Safety of Tongxinluo Capsule in Patients With Coronary Microvascular Disease
1 other identifier
interventional
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2020
Longer than P75 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2020
CompletedFirst Submitted
Initial submission to the registry
January 5, 2020
CompletedFirst Posted
Study publicly available on registry
January 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedJanuary 7, 2020
January 1, 2020
1 year
January 5, 2020
January 5, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Changes of Coronary Flow Reserve
1 year
Study Arms (2)
Tongxinluo Capsule
EXPERIMENTALPlacebo Capsule
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
January 5, 2020
First Posted
January 7, 2020
Study Start
January 1, 2020
Primary Completion
January 1, 2021
Study Completion
January 1, 2025
Last Updated
January 7, 2020
Record last verified: 2020-01