RecruitingPhase 2NCT06533358

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

An Open-label, Sequential Dose Escalation/De-escalation Clinical Trial of MT1002 in Subjects With Acute Coronary Syndrome Undergoing PCI

Sponsor

Shaanxi Micot Pharmaceutical Technology Co., Ltd.

Enrollment

20 participants

Start Date

Feb 27, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Coronary Syndrome

Summary

An Open-label, Sequential Dose Escalation/De-escalation Clinical Trial of MT1002 in Subjects With Acute Coronary Syndrome Undergoing PCI.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria5

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 undertaking any study-related activities
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 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.