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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
Sponsored by
Qilu Hospital of Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  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.

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

    First Posted
    January 5, 2020
    Last Updated
    January 5, 2020
    Sponsor
    Qilu Hospital of Shandong University
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    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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