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NCT06224582Befejeződött

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

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2024. jan. 25.

Rövid összefoglaló (regiszter, angolul)

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.

Állapot (regiszter)
Befejeződött
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
320 (tényleges)
Első benyújtás
2024. jan. 16.
Kezdés
2020. dec. 30.
Elsődleges befejezés
2023. dec. 25.
Fő szponzor
China National Center for Cardiovascular Diseases
NCT-szám
NCT06224582

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Bevont résztvevők: 320
  • 2020. dec. 30. és az elsődleges befejezés (2023. dec. 25.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Korábbi kezelés

  • patients who are currently taking anti-anxiety drug;
  • within the three months before start of the study, patients with myocardial infarction or CCS 4 angina;
  • patients with previous hematopoietic diseases;
  • patients who participate in any other clinical study or take any other investigational drug within 90 days;

Más betegség

  • 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;
  • within 7 days of introduction period, patients who no longer have angina-related symptoms;
  • 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 who have undergone surgery (not including PCI) within the last 4 weeks and are prone to bleeding;
  • 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;

Laborértékek

  • 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;

Életkor

  • women of child-bearing age who do not agree to use contraception during the medication phase;

Egyéb

  • women who are pregnant or preparing to be pregnant or nursing, menstruating women;
  • patients with severe anxiety (Hamilton Anxiety Scale score more than 21);
  • patients with severe depression (Hamilton Depression Scale score not less than 24);
  • 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.

Kiket keres a vizsgálat

  • 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.

Életkor a regiszterben: 18 év – 85 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
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BeijingKínaIsmeretlen állapot

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