Yinxingmihuan Oral Solution in Treatment of Chest Pain After PCI

NCT06224582 | Completed

• 1 other identifier: Yinxingmihuan01
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Stable Angina

Outcome Measures

Primary Outcomes (1)

• SAQ-angina frequency

  angina frequency assessed on the basis of Seattle Angina Questionnaire (SAQ-AF)

  at 12-week follow-up

Secondary Outcomes (9)

• HAMA improvement

  at 12-week follow-up

• CCS grade

  before randomization, in 4,8,12,16 and 20 weeks

• NYHA class

  before randomization, in 4,8,12,16 and 20 weeks

• VAS

  before randomization, in 4,8,12,16 and 20 weeks

• HAMA reductive ratio

  at 12-week follow-up

Other Outcomes (4)

• SAQ-PL

  before randomization, in 4,8,12,16 and 20 weeks

• SAQ-AS

  before randomization, in 4,8,12,16 and 20 weeks

• SAQ-TS

  before randomization, in 4,8,12,16 and 20 weeks

Study Arms (2)

Yinxingmihuan group

EXPERIMENTAL

standardized medical treatment regimen plus Yinxingmihuan oral solution (oral, 10 ml once, 3 times a day)

Drug: Yinxingmihuan oral solution

Placebo group

PLACEBO COMPARATOR

standardized medical treatment regimen plus Placebo oral solution (oral, 10 ml once, 3 times a day)

Drug: Placebo

Interventions

Yinxingmihuan oral solution DRUG

Yinxingmihuan oral solution is made of Ginkgo leaf extract and armillariella mellea powders.

Also known as: Ginkgo leaf extract and armillariella mellea powders

Yinxingmihuan group

Placebo DRUG

The placebo oral solution is in the same appearance, color, smell and taste as the experimental Yinxingmihuan oral solution.

Placebo group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Hospital, National Center for Cardiovascular Diseases，Chinese Academy of Medical Sciences

Beijing, 100037, China

Location

MeSH Terms

Conditions

Angina, Stable

Interventions

Ginkgo biloba extract

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 25, 2024
• Study Start: December 30, 2020
• Primary Completion: December 25, 2023
• Study Completion: December 25, 2023
• Last Updated: January 25, 2024

Record last verified: 2021-03

Locations

CN (1)