A Clinical Study of MT1002 in Subjects With Acute Coronary Syndrome Undergoing PCI

Exclusion Criteria23

• cardiogenic shock, or cardiopulmonary resuscitation (CPR）
• Suspicious aortic dissection, pericarditis, endocarditis
• Has any history of intracranial hemorrhage or structural abnormalities
• Transient ischemic attack, stroke within 6 months
• History of gastrointestinal or genitourinary bleeding within 1 month
• Major surgery within 1 month
• The following surgeries are planned within 1 month of enrollment: CABG, valve surgery, or other invasive procedures
• Long-term treatment with non-steroidal anti-inflammatory drugs (except aspirin), cyclooxygenase (COX)-2 inhibitors, within 1 month prior to screening
• 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.
• Use of coumarin derivatives and/or factor Xa inhibitors in the past 7 days
• Anticipated need for oral anticoagulants within 3 days of dosing
• Severe uncontrolled hypertension persists even within 24 hours of adequate treatment
• According to the judgment of the investigator, the subject has a high risk of bleeding, such as active bleeding, bleeding tendency, coagulation disorders, etc
• Known associated hematologic abnormalities
• Known to have a malignancy or comorbid other disease that may lead to protocol non-adherence with a life expectancy of < 1 year
• Known severe liver disease
• Known hepatitis B and hepatitis C, HIV screening serology positive, except for the low viral replication phase.
• Known chronic kidney disease
• Known allergy or intolerance to aspirin, clopidogrel, ticagrelor, prasugrel, bivalirudin, unfractionated heparin, P2Y12 antagonists, or contrast agents.
• 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)
• Subjects who have previously used MT1002.
• Unable to fully cooperate with the study protocol.
• Has any other medical or psychiatric illness that, in the opinion of the investigator, precludes participation in the study.