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

NCT06533358 | Recruiting Phase 2 FDA Drug

• 1 other identifier: MT1002-II-C04
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (1)

MT1002 Injection

EXPERIMENTAL

MT1002 is infused once only, once for 4h

Drug: MT1002 Injection

Interventions

MT1002 Injection DRUG

MT1002 is infused once only, once for 4h. MT1002 is for subjects with acute coronary syndrome undergoing PCI

Also known as: No other name

MT1002 Injection

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≥ 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 may not qualify if:

• cardiogenic shock, or cardiopulmonary resuscitation (CPR）
• Suspicious aortic dissection, pericarditis, endocarditis
• Has any history of intracranial hemorrhage or structural abnormalities
• Transient ischemic attack, stroke within 6 months
• History of gastrointestinal or genitourinary bleeding within 1 month
• Major surgery within 1 month
• The following surgeries are planned within 1 month of enrollment: CABG, valve surgery, or other invasive procedures
• Long-term treatment with non-steroidal anti-inflammatory drugs (except aspirin), cyclooxygenase (COX)-2 inhibitors, within 1 month prior to screening
• 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.
• 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 persists even within 24 hours of adequate treatment
• According to the judgment of the investigator, the subject has a high risk of bleeding, such as active bleeding, bleeding tendency, coagulation disorders, etc
• Known associated hematologic abnormalities
• Known to have a malignancy or comorbid other disease that may lead to protocol non-adherence with a life expectancy of \< 1 year

Sponsors & Collaborators

• Shaanxi Micot Pharmaceutical Technology Co., Ltd.: lead

Study Sites (2)

Beijing Anzhen Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 100029, China

RECRUITING

Xianyang Hospital, Yan'an University

Xi'an, Shaanxi, 712000, China

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Changsheng Ma, Medical phd

  Beijing Anzhen Hospital Affiliated to Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Changsheng Ma, Medical phd

CONTACT

13501373114; chshma@vip.sina.com

NA NA NA

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: August 1, 2024
• Study Start: February 27, 2024
• Primary Completion: December 1, 2024
• Study Completion: July 1, 2025
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)