Actively Recruiting
A Clinical Study of MT1002 in Subjects With Acute Coronary Syndrome Undergoing PCI
Led by Shaanxi Micot Pharmaceutical Technology Co., Ltd. · Updated on 2024-08-01
20
Participants Needed
2
Research Sites
70 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
An Open-label, Sequential Dose Escalation/De-escalation Clinical Trial of MT1002 in Subjects With Acute Coronary Syndrome Undergoing PCI.
CONDITIONS
Official Title
A Clinical Study of MT1002 in Subjects With Acute Coronary Syndrome Undergoing PCI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 65 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
You will not qualify if you...
- Cardiogenic shock or cardiopulmonary resuscitation (CPR)
- Suspicious aortic dissection, pericarditis, or endocarditis
- History of intracranial hemorrhage or structural abnormalities
- Transient ischemic attack or stroke within 6 months
- History of gastrointestinal or genitourinary bleeding within 1 month
- Major surgery within 1 month
- Planned surgeries within 1 month of enrollment: CABG, valve surgery, or other invasive procedures
- Long-term treatment with non-steroidal anti-inflammatory drugs (except aspirin) or cyclooxygenase (COX)-2 inhibitors within 1 month prior to screening
- Prior or planned use of thrombolytic agents, bivalirudin, or fondaparinux within 7 days prior to enrollment
- Unfractionated heparin or low molecular weight heparin injected subcutaneously within 12 hours before enrollment
- 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 persisting within 24 hours of adequate treatment
- High risk of bleeding such as active bleeding, bleeding tendency, or coagulation disorders
- Known hematologic abnormalities
- Known malignancy or comorbid disease with life expectancy less than 1 year
- Known severe liver disease
- Known positive hepatitis B, hepatitis C, or HIV screening serology except 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 below 50.0 kg for males or below 45.0 kg for females, or body mass index outside 18.0 to 30.0 kg/m2
- Previous use of MT1002
- Unable to fully cooperate with the study protocol
- Any other medical or psychiatric illness that precludes participation according to the investigator's opinion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Beijing Anzhen Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 100029
Actively Recruiting
2
Xianyang Hospital, Yan'an University
Xi'an, Shaanxi, China, 712000
Actively Recruiting
Research Team
C
Changsheng Ma, Medical phd
CONTACT
N
NA NA NA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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