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:
2025-12-25 @ 12:15 AM
Ignite Modification Date:
2025-12-25 @ 12:15 AM
NCT ID:
NCT06533358
Eligibility Criteria:
Inclusion Criteria:
1. Male and female aged 18-85 years old (both 18 and 85 years old)
2. Diagnosis of acute coronary syndrome (ACS)
3. Subjects who will undergo PCI during hospitalization
4. Able to understand and willing to sign written informed consent prior to undertaking any study-related activities
5. Females of childbearing potential must have a negative pregnancy test result prior to enrollment or be postmenopausal for at least 1 year, or permanently sterilized for ≥ 6 weeks. For women of childbearing potential and men with female partners of childbearing potential, effective contraception must be used if they are sexually active from the time of informed consent until 90 days after MT1002 administration
Exclusion Criteria:
1. cardiogenic shock, or cardiopulmonary resuscitation (CPR）
2. Suspicious aortic dissection, pericarditis, endocarditis
3. Has any history of intracranial hemorrhage or structural abnormalities
4. Transient ischemic attack, stroke within 6 months
5. History of gastrointestinal or genitourinary bleeding within 1 month
6. Major surgery within 1 month
7. The following surgeries are planned within 1 month of enrollment: CABG, valve surgery, or other invasive procedures
8. Long-term treatment with non-steroidal anti-inflammatory drugs (except aspirin), cyclooxygenase (COX)-2 inhibitors, within 1 month prior to screening
9. Prior (within 7 days prior to enrollment) or planned use of thrombolytic agents, bivalirudin, or fondaparinux. 12 hours before enrollment, unfractionated heparin or low molecular weight heparin was injected subcutaneously.
10. Use of coumarin derivatives and/or factor Xa inhibitors in the past 7 days
11. Anticipated need for oral anticoagulants within 3 days of dosing
12. Severe uncontrolled hypertension persists even within 24 hours of adequate treatment
13. According to the judgment of the investigator, the subject has a high risk of bleeding, such as active bleeding, bleeding tendency, coagulation disorders, etc
14. Known associated hematologic abnormalities
15. Known to have a malignancy or comorbid other disease that may lead to protocol non-adherence with a life expectancy of \< 1 year
16. Known severe liver disease
17. Known hepatitis B and hepatitis C, HIV screening serology positive, except for the low viral replication phase.
18. Known chronic kidney disease
19. Known allergy or intolerance to aspirin, clopidogrel, ticagrelor, prasugrel, bivalirudin, unfractionated heparin, P2Y12 antagonists, or contrast agents.
20. Weight: male subjects should not be less than 50.0kg, female subjects should not be less than 45.0kg, and body mass index within the range of 18.0\~30.0kg/m2 (including boundary values)
21. Subjects who have previously used MT1002.
22. Unable to fully cooperate with the study protocol.
23. Has any other medical or psychiatric illness that, in the opinion of the investigator, precludes participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT06533358
Study Brief:
Protocol Section:
NCT06533358