Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2025-12-24 @ 2:07 PM
NCT ID:
NCT06618495
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06618495
Study Brief:
Protocol Section:
NCT06618495