Yinxingmihuan Oral Solution in Treatment of Chest Pain After PCI

January 16, 2024 updated by: China National Center for Cardiovascular Diseases

Efficacy and Safety of Yinxingmihuan Oral Solution in Treatment of Chest Pain After PCI: A Multicenter, Prospective, Randomized, Double-blind, Placebo-Controlled Study

A prospective, multi-center, double-blind, randomized, placebo-controlled trial is conducted to evaluate the efficacy and safety of Yinxingmihuan oral solution in the treatment of chest pain after percutaneous coronary intervention (PCI) in patients with stable angina. Patients should undergo at least 1-week standardized medical treatment phase before randomization. The primary end point is the 12-week angina frequency assessed on the basis of Seattle Angina Questionnaire (SAQ) subscales. The main secondary endpoint is the improvement of anxiety assessed by Hamilton Anxiety Scale (HAMA) to evaluate its effectiveness for chest pain caused by psychological factors.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
320

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100037
        • Fuwai Hospital, National Center for Cardiovascular Diseases，Chinese Academy of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • male or female aged 18-85 years;
  • patients with a history of percutaneous coronary intervention for coronary heart disease for more than 30 days and less than 180 days, without need of further elective coronary revascularization (PCI, CABG) judged by cardiovascular specialists;
  • patients with symptoms such as chest distress, chest pain, palpitation, pain in shoulder and back, shortness of breath, weakness, activity intolerance, etc. Angina frequency (AF) score in Seattle Angina Questionnaire (SAQ) no more than 80;
  • Hamilton Anxiety Scale score between 7 and 21 (mild to moderate anxiety);
  • written informed consent.

Exclusion Criteria:

  • women who are pregnant or preparing to be pregnant or nursing, menstruating women;
  • women of child-bearing age who do not agree to use contraception during the medication phase;
  • patients with severe anxiety (Hamilton Anxiety Scale score more than 21);
  • patients with severe depression (Hamilton Depression Scale score not less than 24);
  • patients who are currently taking anti-anxiety drug;
  • participants with stable angina classified into Canadian Cardiovascular Society (CCS) Grade 4;
  • uncontrolled hypertension (systolic > 180 mmHg or diastolic > 100 mmHg) despite using ongoing antihypertensive treatment;
  • heart failure assessed by New York Heart Association (NYHA);
  • patients with coronary heart disease and atrial fibrillation;
  • clinically significant complications, including liver dysfunction (ALT or AST level more than 2 times higher than normal), renal dysfunction (serum creatinine level more than 2 times higher than normal), severe cardiopulmonary dysfunction, pulmonary hypertension, chronic obstructive pulmonary disease, history of cerebral hemorrhage or epilepsy, with need of anticonvulsant drugs;
  • within 7 days of introduction period, patients who no longer have angina-related symptoms;
  • within the three months before start of the study, patients with myocardial infarction or CCS 4 angina;
  • patients with acute coronary syndrome confirmed by examinations and other chest pain caused by rheumatic heart disease, dilated cardiomyopathy, severe neurosis, menopausal syndrome, hyperthyroidism, cervical spondylosis, bilio-cardiac syndrome, gastroesophageal reflux, hiatal hernia, aortic dissection, pulmonary embolism, mediastinal hematoma, etc;
  • history of specific bleeding or bleeding caused by warfarin;
  • patients with previous hematopoietic diseases;
  • patients who have undergone surgery (not including PCI) within the last 4 weeks and are prone to bleeding;
  • patients who participate in any other clinical study or take any other investigational drug within 90 days;
  • patients who are known or suspected to be allergic to the drug in this study or are allergic constitution;
  • drug abusers who have a history of alcohol abuse or drug dependence in the past 2 years;
  • psychopath;
  • patients who have been judged by their doctors to be ineligible for the study;
  • patient who is a family member or relative of the staff working in the centers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Yinxingmihuan group
standardized medical treatment regimen plus Yinxingmihuan oral solution (oral, 10 ml once, 3 times a day)
Drug: Yinxingmihuan oral solution
Yinxingmihuan oral solution is made of Ginkgo leaf extract and armillariella mellea powders.
Other Names:
  • Ginkgo leaf extract and armillariella mellea powders
Placebo Comparator: Placebo group
standardized medical treatment regimen plus Placebo oral solution (oral, 10 ml once, 3 times a day)
Drug: Placebo
The placebo oral solution is in the same appearance, color, smell and taste as the experimental Yinxingmihuan oral solution.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
SAQ-angina frequency
Time Frame: at 12-week follow-up
angina frequency assessed on the basis of Seattle Angina Questionnaire (SAQ-AF)
at 12-week follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
HAMA improvement
Time Frame: at 12-week follow-up
variation of the value of Hamilton Anxiety Scale (HAMA) at 12-week follow-up compared with baseline
at 12-week follow-up
CCS grade
Time Frame: before randomization, in 4,8,12,16 and 20 weeks
angina grade assessed by Canadian Cardiovascular Society (CCS)
before randomization, in 4,8,12,16 and 20 weeks
NYHA class
Time Frame: before randomization, in 4,8,12,16 and 20 weeks
heart function assessed by New York Heart Association (NYHA)
before randomization, in 4,8,12,16 and 20 weeks
VAS
Time Frame: before randomization, in 4,8,12,16 and 20 weeks
generic health status assessed by visual analogue scale (VAS)
before randomization, in 4,8,12,16 and 20 weeks
HAMA reductive ratio
Time Frame: at 12-week follow-up
variation of Hamilton Anxiety Scale (HAMA) score at 12-week follow-up compared with baseline divided by the baseline value
at 12-week follow-up
HAMD depression score
Time Frame: before randomization, in 4,8,12,16 and 20 weeks
proportion of participants with improvement or disappear of depression according to Hamilton Depression Scale (HAMD)
before randomization, in 4,8,12,16 and 20 weeks
weekly angina frequency
Time Frame: before randomization, in 4,8,12,16 and 20 weeks
weekly angina frequency recorded by the participants' diary cards
before randomization, in 4,8,12,16 and 20 weeks
SF-12 score
Time Frame: before randomization, in 4,8,12,16 and 20 weeks
generic health status measured by 12-Item Short Form Health Survey (SF-12)
before randomization, in 4,8,12,16 and 20 weeks
Nitroglycerin discontinuation rate
Time Frame: before randomization, in 4,8,12,16 and 20 weeks
proportion of participants that no longer need any nitroglycerin medications
before randomization, in 4,8,12,16 and 20 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
SAQ-PL
Time Frame: before randomization, in 4,8,12,16 and 20 weeks
Physical limitation assessed on the basis of Seattle Angina Questionnaire
before randomization, in 4,8,12,16 and 20 weeks
SAQ-AS
Time Frame: before randomization, in 4,8,12,16 and 20 weeks
Anginal stability assessed on the basis of Seattle Angina Questionnaire
before randomization, in 4,8,12,16 and 20 weeks
SAQ-TS
Time Frame: before randomization, in 4,8,12,16 and 20 weeks
Treatment satisfaction assessed on the basis of Seattle Angina Questionnaire
before randomization, in 4,8,12,16 and 20 weeks
SAQ-DP
Time Frame: before randomization, in 4,8,12,16 and 20 weeks
Disease perception assessed on the basis of Seattle Angina Questionnaire
before randomization, in 4,8,12,16 and 20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China National Center for Cardiovascular Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 30, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 25, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 25, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 25, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Yinxingmihuan01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Stable Angina

Clinical Trials on Yinxingmihuan oral solution

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings