Actively Recruiting
Open-label Dose Escalation and De-escalation Trial of MT1002 in Acute Coronary Syndrome Patients Undergoing PCI
Led by Shaanxi Micot Pharmaceutical Technology Co., Ltd. · Updated on 2024-08-01
20
Participants Needed
2
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial investigates MT1002, a new synthetic peptide designed to work as both a blood thinner and platelet inhibitor, for patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). The study is open-label and aims to evaluate the safety and dosing of MT1002 in this group of patients. The trial is sponsored by Shaanxi Micot Pharmaceutical Technology Co., Ltd. and is in a Phase 2 stage, focusing on careful dose adjustments and monitoring. Participants receive a single intravenous infusion of MT1002, starting with a loading dose followed by a maintenance dose over 4 hours. The initial dose is 0.60 mg/kg as a bolus, then 1.2 mg/kg per hour for 4 hours. A Safety Review Committee monitors responses to adjust doses as needed to ensure patient safety. This sequential dose escalation and de-escalation process helps identify the appropriate dose range. During the study, participants are closely monitored for blood clotting times (ACT) and major bleeding events from the day of treatment up to 30 days afterward. Researchers collect data on how many patients achieve the target clotting time and track any bleeding complications. The study includes regular assessments and safety follow-up to understand the treatment's impact and side effects over this period.
CONDITIONS
Brief 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 to 85 years old (inclusive)
- Diagnosed with acute coronary syndrome (ACS)
- Scheduled to undergo PCI during hospitalization
- Able to understand and willing to sign written informed consent
- Females of childbearing potential must have a negative pregnancy test or be postmenopausal for at least 1 year, or permanently sterilized for at least 6 weeks
- Effective contraception must be used by women of childbearing potential and men with partners of childbearing potential from consent until 90 days after MT1002 administration
You will not qualify if you...
- Cardiogenic shock or undergoing cardiopulmonary resuscitation
- Suspected aortic dissection, pericarditis, or endocarditis
- History of intracranial hemorrhage or structural brain abnormalities
- Transient ischemic attack or stroke within 6 months
- Gastrointestinal or genitourinary bleeding within 1 month
- Major surgery within 1 month
- Planned CABG, valve surgery, or other invasive procedures within 1 month
- Long-term use of non-steroidal anti-inflammatory drugs (except aspirin) or COX-2 inhibitors within 1 month
- Use of thrombolytic agents, bivalirudin, or fondaparinux within 7 days prior to enrollment
- Use of coumarin derivatives or factor Xa inhibitors within past 7 days
- Anticipated need for oral anticoagulants within 3 days of dosing
- Severe uncontrolled hypertension despite treatment
- High risk of bleeding or known bleeding disorders
- Known hematologic abnormalities
- Known malignancy or other comorbidities affecting study adherence with life expectancy under 1 year
- Severe liver disease
- Positive hepatitis B, hepatitis C, or HIV (except low viral replication phase)
- Chronic kidney disease
- Allergy or intolerance to aspirin, clopidogrel, ticagrelor, prasugrel, bivalirudin, heparin, P2Y12 antagonists, or contrast agents
- Weight below 50 kg for males or 45 kg for females; BMI outside 18.0 to 30.0 kg/m2
- Prior use of MT1002
- Unable to cooperate fully with the protocol
- Other medical or psychiatric illnesses that prevent participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants receive a single intravenous infusion of MT1002 during PCI to treat acute coronary syndrome.
1 infusion visit
Duration - Up to 30 days after treatment
Participants are monitored for safety and treatment effects after receiving MT1002, including assessment of bleeding events and target ACT levels.
Visits at Day 2 and Day 30±2 days
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
N
NA NA NA
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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