Akut Koroner Sendromun Tedavisinde Xuesaitong Yumuşak Kapsülün Klinik Çalışması ve Moleküler Mekanizması

Sade dilde özet

Bu çalışma, Xuesaitong yumuşak kapsül (ana bileşeni Panax notoginseng saponinleri olan bitkisel bir ürün) adlı tedavinin akut koroner sendrom (acute coronary syndrome, kalbi besleyen damarların aniden daralması veya tıkanması) tedavisindeki etkisini ve moleküler mekanizmasını incelemektedir. Çalışmaya, koroner girişim sonrası ilk 4 hafta içinde olan, 18-80 yaş arasındaki hastalar katılabilmiştir. Faz 1/Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

PHASE1/PHASE2

Durum

Tamamlandı

Sponsor

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Müdahale

Xuesaitong soft capsule (main ingredient is Panax notoginseng saponins)

Başlangıç

23.12.2024

Tahmini bitiş

25.11.2025

Ülkeler

China

İlgili genler

Merkezler

• Beijing, China

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

* (1) it accords with the diagnostic criteria of western medicine for acute coronary syndrome.

  (2) within 4 weeks after coronary intervention.

  (3) 18 years old ≤ age ≤ 80 years old, male or female.

  (4) voluntarily participate in this clinical trial, give informed consent and sign an informed consent form

Exclusion Criteria:

* (1) uncontrollable hypertension after drug treatment (systolic blood pressure \> 180mmHg, or diastolic blood pressure \> 110mmHg).

  (2) increased risk of bleeding: previous history of hemorrhagic stroke; intracranial aneurysms; trauma or major surgery within 1 month (including bypass surgery); diseases currently suffering from active bleeding, etc.

  (3) patients with history of digestive tract ulcer and massive gastrointestinal bleeding.

  (4) severe organic heart disease, such as patients with LVEF \< 35% or NYHA/Killip cardiac function grade IV.

  (5) those with a history of malignant arrhythmias (arrhythmias affected by hemodynamics, requiring drug or electrical cardioversion, or cardiopulmonary resuscitation), congenital heart disease or malignant tumor were considered unable to participate in the trial.

  (6) severe hepatic and renal insufficiency: glutamic pyruvic transaminase (ALT) or aspartate oxaloacetic transaminase (AST) ≥ 3 × normal upper limit (ULN) or total bilirubin (TBIL) ≥ 2 × ULN; or creatinine clearance (Ccr \< 30ml/min).

  (7) Women in pregnancy (defined as positive blood pregnancy test) and lactating women.

  (8) those with a history of blood donation or significant blood loss in the last 3 months (≥ 400ml).

  (9) people with a previous history of alcoholism (i.e. men drink more than 28 standard units per week and women drink more than 21 standard units per week (1 standard unit contains 14g alcohol, such as 360mL beer or 25mL spirits or 150mL wine with 40% alcohol content); or screen those who drink regularly in the first 6 months (that is, more than 14 standard units per week).

  (10) those with a history of drug abuse and drug dependence within one year before screening.

  (11) those who have participated in other clinical trials and taken trial drugs in the past 3 months.

  (12) people who are allergic or intolerant to aspirin or P2Y12 receptor inhibitors.

  (13) those who are allergic to the ingredients of the test drugs.

  (14) other situations in which the researchers think it is not appropriate to participate in this experiment.