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

Last updated: July 31, 2024
Sponsor: Shaanxi Micot Technology Limited Company
Overall Status: Active - Recruiting

Phase

2

Condition

Chest Pain

Angina

Myocardial Ischemia

Treatment

MT1002 Injection

Clinical Study ID

NCT06533358
MT1002-II-C04
  • Ages 18-85
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 undertakingany study-related activities

  5. 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:

  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, valvesurgery, 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 orlow 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 ofbleeding, 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 protocolnon-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 thelow 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 beless than 45.0kg, and body mass index within the range of 18.0~30.0kg/m2 (includingboundary 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 theinvestigator, precludes participation in the study.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: MT1002 Injection
Phase: 2
Study Start date:
February 27, 2024
Estimated Completion Date:
July 31, 2025

Study Description

MT1002 is a novel 32-amino acid synthetic peptide aimed to combine molecular functions of both a direct thrombin inhibitor and a platelet glycoprotein IIb/IIIa receptor antagonist, indicated for use as an antithrombotic and anticoagulant in patients with ACS and in patients undergoing PCI.

This study is an Open-label, sequential dose escalation/de-escalation clinical trial of MT1002 in subjects with acute coronary syndrome undergoing PCI. First dose cohort is 0.60 mg/kg (initial loading dose, intravenous bolus) + 1.2 mg/kg/h*4 h (maintenance dose, intravenous infusion). The Safety Review Committee makes decisions on subsequent dose adjustments. Dose escalation/de-escalation and stopping rules have been put in place to ensure the safety of the patients in this study.

Connect with a study center

  • Beijing Anzhen Hospital Affiliated to Capital Medical University

    Beijing, Beijing 100029
    China

    Active - Recruiting

  • Xianyang Hospital, Yan'an University

    Xi'an, Shaanxi 712000
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.