Yinxingmihuan Oral Solution in Treatment of Chest Pain After PCI

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: Completed
• Conditions: Chronic Stable Angina
• Intervention / Treatment: Drug: Yinxingmihuan oral solution; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
SAQ-angina frequency	angina frequency assessed on the basis of Seattle Angina Questionnaire (SAQ-AF)	at 12-week follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HAMA improvement	variation of the value of Hamilton Anxiety Scale (HAMA) at 12-week follow-up compared with baseline	at 12-week follow-up
CCS grade	angina grade assessed by Canadian Cardiovascular Society (CCS)	before randomization, in 4,8,12,16 and 20 weeks
NYHA class	heart function assessed by New York Heart Association (NYHA)	before randomization, in 4,8,12,16 and 20 weeks
VAS	generic health status assessed by visual analogue scale (VAS)	before randomization, in 4,8,12,16 and 20 weeks
HAMA reductive ratio	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	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	weekly angina frequency recorded by the participants' diary cards	before randomization, in 4,8,12,16 and 20 weeks
SF-12 score	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	proportion of participants that no longer need any nitroglycerin medications	before randomization, in 4,8,12,16 and 20 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
SAQ-PL	Physical limitation assessed on the basis of Seattle Angina Questionnaire	before randomization, in 4,8,12,16 and 20 weeks
SAQ-AS	Anginal stability assessed on the basis of Seattle Angina Questionnaire	before randomization, in 4,8,12,16 and 20 weeks
SAQ-TS	Treatment satisfaction assessed on the basis of Seattle Angina Questionnaire	before randomization, in 4,8,12,16 and 20 weeks
SAQ-DP	Disease perception assessed on the basis of Seattle Angina Questionnaire	before randomization, in 4,8,12,16 and 20 weeks

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2020
• Primary Completion (Actual): December 25, 2023
• Study Completion (Actual): December 25, 2023

Study Registration Dates

• First Submitted: January 16, 2024
• First Submitted That Met QC Criteria: January 16, 2024
• First Posted (Estimated): January 25, 2024

Study Record Updates

• Last Update Posted (Estimated): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Angina Pectoris; Chest Pain; Angina, Stable
• Other Study ID 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