MT1002 treatment for patients 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

This study is testing a new treatment called MT1002 to see if it can help people with acute coronary syndrome feel better during their heart procedure.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Shaanxi Micot Pharmaceutical Technology Co., Ltd. (Industry-sponsored)
• Locations: 2 sites (Beijing, Beijing Municipality and 1 other locations)
• Trial ID: NCT06533358 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of MT1002, a synthetic peptide designed to act as both a direct thrombin inhibitor and a platelet glycoprotein IIb/IIIa receptor antagonist, in patients diagnosed with acute coronary syndrome (ACS) who are undergoing percutaneous coronary intervention (PCI). The study employs an open-label, sequential dose escalation and de-escalation methodology, starting with an initial loading dose followed by a maintenance infusion. A Safety Review Committee will oversee dose adjustments to ensure patient safety throughout the trial.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-85 who have been diagnosed with acute coronary syndrome and are scheduled for PCI.

Not a fit: Patients with severe complications such as cardiogenic shock or recent history of stroke may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients with acute coronary syndrome undergoing PCI by providing effective antithrombotic and anticoagulant therapy.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in the use of combined antithrombotic therapies, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Male and female aged 18-85 years old (both 18 and 85 years old)
2. Diagnosis of acute coronary syndrome (ACS)
3. Subjects who will undergo PCI during hospitalization
4. Able to understand and willing to sign written informed consent prior to undertaking any study-related activities
5. 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 Criteria:

1. cardiogenic shock, or cardiopulmonary resuscitation (CPR）
2. Suspicious aortic dissection, pericarditis, endocarditis
3. Has any history of intracranial hemorrhage or structural abnormalities
4. Transient ischemic attack, stroke within 6 months
5. History of gastrointestinal or genitourinary bleeding within 1 month
6. Major surgery within 1 month
7. The following surgeries are planned within 1 month of enrollment: CABG, valve surgery, or other invasive procedures
8. Long-term treatment with non-steroidal anti-inflammatory drugs (except aspirin), cyclooxygenase (COX)-2 inhibitors, within 1 month prior to screening
9. 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.
10. Use of coumarin derivatives and/or factor Xa inhibitors in the past 7 days
11. Anticipated need for oral anticoagulants within 3 days of dosing
12. Severe uncontrolled hypertension persists even within 24 hours of adequate treatment
13. According to the judgment of the investigator, the subject has a high risk of bleeding, such as active bleeding, bleeding tendency, coagulation disorders, etc
14. Known associated hematologic abnormalities
15. Known to have a malignancy or comorbid other disease that may lead to protocol non-adherence with a life expectancy of \< 1 year
16. Known severe liver disease
17. Known hepatitis B and hepatitis C, HIV screening serology positive, except for the low viral replication phase.
18. Known chronic kidney disease
19. Known allergy or intolerance to aspirin, clopidogrel, ticagrelor, prasugrel, bivalirudin, unfractionated heparin, P2Y12 antagonists, or contrast agents.
20. 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)
21. Subjects who have previously used MT1002.
22. Unable to fully cooperate with the study protocol.
23. Has any other medical or psychiatric illness that, in the opinion of the investigator, precludes participation in the study.

Where this trial is running

Beijing, Beijing Municipality and 1 other locations

• Beijing Anzhen Hospital Affiliated to Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
• Xianyang Hospital, Yan'an University — Xi'an, Shaanxi, China (Recruiting)

Study contacts

• Principal investigator: Changsheng Ma, Medical phd — Beijing Anzhen Hospital
• Study coordinator: Changsheng Ma, Medical phd

Conditions Acute Coronary Syndrome