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

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

Study Overview

• Status: Recruiting
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Drug: MT1002 Injection

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Changsheng Ma, Medical phd; Phone Number: 13501373114; Email: chshma@vip.sina.com
• Study Contact Backup: Name: NA NA NA

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Recruiting
      • Beijing Anzhen Hospital Affiliated to Capital Medical University
      • Contact: Changsheng Ma, Medical phd; Phone Number: 13501373114; Email: chshma@vip.sina.com
  • Shaanxi
    • Xi'an, Shaanxi, China, 712000
      • Recruiting
      • Xianyang Hospital, Yan'an University
      • Contact: Qiufang Lian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MT1002 Injection; MT1002 is infused once only, once for 4h	Drug: MT1002 Injection; MT1002 is infused once only, once for 4h. MT1002 is for subjects with acute coronary syndrome undergoing PCI; Other Names: No other name

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of subjects who achieved target ACT (200-300 s)	percentage of subjects achieving target ACT (200-300 s) among subjects receiving MT1002 (not switching to standard care) pre/intraoperatively and after successful PCI	Day 1, 24 hours （Day 2） to Day 30±2 after intravenous injection on Day 1
Major bleeding events	Adverse events (AEs): Major bleeding events (Bleeding Academic Research Consortium [BARC] type 3-5)	Day 1 to end of follow-up period (Day 30±2)

Collaborators and Investigators

• Sponsor: Shaanxi Micot Technology Limited Company
• Investigators: Principal Investigator: Changsheng Ma, Medical phd, Beijing Anzhen Hospital Affiliated to Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: July 18, 2024
• First Submitted That Met QC Criteria: July 31, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2024
• Last Update Submitted That Met QC Criteria: July 31, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: MT1002-II-C04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No