Phase
Condition
Chest Pain
Angina
Myocardial Ischemia
Treatment
MT1002 Injection
Clinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male and female aged 18-85 years old (both 18 and 85 years old)
Diagnosis of acute coronary syndrome (ACS)
Subjects who will undergo PCI during hospitalization
Able to understand and willing to sign written informed consent prior to undertakingany study-related activities
Females of childbearing potential must have a negative pregnancy test result priorto enrollment or be postmenopausal for at least 1 year, or permanently sterilizedfor ≥ 6 weeks. For women of childbearing potential and men with female partners ofchildbearing potential, effective contraception must be used if they are sexuallyactive from the time of informed consent until 90 days after MT1002 administration
Exclusion
Exclusion Criteria:
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, valvesurgery, 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 orlow 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 ofbleeding, 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 protocolnon-adherence with a life expectancy of < 1 year
Known severe liver disease
Known hepatitis B and hepatitis C, HIV screening serology positive, except for thelow 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 beless than 45.0kg, and body mass index within the range of 18.0~30.0kg/m2 (includingboundary 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 theinvestigator, precludes participation in the study.
Study Design
Study Description
Connect with a study center
Beijing Anzhen Hospital Affiliated to Capital Medical University
Beijing, Beijing 100029
ChinaActive - Recruiting
Xianyang Hospital, Yan'an University
Xi'an, Shaanxi 712000
ChinaActive - Recruiting
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