MT1002 Phase II Study in ACS Patients With PCI

Open-Label, Sequential-Dose Escalation/De-escalation Trial Testing MT1002 in Patients Undergoing PCI Due to Acute Coronary Syndrome With NSTEMI

This is an open-label, sequential-dose escalation/de-escalation trial testing 3 dose levels of MT1002 in patients undergoing PCI due to ACS with NSTEMI. Three doses of MT1002 will be sequentially tested in cohorts of 6 patients each to achieve target ACT.

Study Overview

• Status: Terminated
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Drug: MT1002 for 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 to investigate the safety, tolerability, and efficacy of MT1002 in patients undergoing PCI due to ACS with NSTEMI.

This study is a single dose, sequential-dose escalation study in patients undergoing PCI due to ACS with NSTEMI. The first 2 doses were considered safe and well tolerated in the Phase 1 healthy subject study. The third dose to be given will be determined based on the safety and efficacy results from the first 2 doses. Dose escalation/de-escalation and stopping rules have been put in place to ensure the safety of the patients in this study.

The patients will receive a single MT1002 close to the initiation of PCI (Day 1) followed by 4 hours of IV infusion and follow-up at Day 2, Day 14, and Day 30.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Muncie, Indiana, United States, 47303
      • IU Health - BMH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Males and females ≥ 18 to 85 years of age.
2. Diagnosed with NSTEMI.
3. Patients who will undergo PCI during the index hospitalization for an NSTEMI.
4. Ability to understand and willing to give written informed consent.
5. Women of childbearing potential must have a negative pregnancy test or be post-menopausal for at least 1 year before enrollment or be permanently sterilized since ≥6 weeks. Females of childbearing potential and males with partners of childbearing potential must be using effective contraception.

Exclusion Criteria:

1. .Cardiogenic shock or prolonged cardiopulmonary resuscitation (CPR).
2. Active bleeding, bleeding diathesis, coagulopathy.
3. Any history of intracranial bleeding or structural abnormalities.
4. Prior transient ischemic attack, prior stroke within 6 months.
5. Index MI is STEMI or new left bundle branch block.
6. The following planned procedures within 30 days after enrollment: staged PCI, CABG, valve surgery, or additional invasive procedures.
7. Pre-existing atrial fibrillation or prolonged QTcF (470ms in men, 480ms in women).
8. Anticipated requirement for oral anticoagulants before Day 30.
9. CRUSADE bleeding risk score >40.
10. Suspected aortic dissection.
11. History of gastrointestinal or genitourinary bleeding within the previous 3 months.
12. Refusal to receive blood transfusion if needed during the study.
13. Major surgery in the last month.
14. History of heparin-induced thrombocytopenia and bleeding diathesis.
15. Severe uncontrolled hypertension.
16. Prior (within 30 days prior to enrollment) or planned administration of thrombolytics, glycoprotein IIb/IIIa inhibitors, bivalirudin, or fondaparinux for the index MI.
17. Known relevant hematological deviations: hemoglobin (male) < 11 g/dL, hemoglobin (female) < 10 g/dL, hematocrit < 35%, platelet count < 100,000 cells/µL.
18. Use of Coumadin derivatives and/or Factor Xa inhibitor drugs within the last 7 days.
19. Chronic therapy with non-steroidal anti-inflammatory drugs (NSAIDs; except aspirin) , cyclooxygenase (COX)-2 inhibitors within 1 month before screening.
20. Known malignancies or other comorbid conditions with life expectancy < 1 year.
21. Known severe liver disease (i.e., aspartate aminotransferase [AST], alanine aminotransferase [ALT] > 3 × ULN).
22. Known positive serology for hepatitis B & C, HIV screen.
23. Known chronic kidney disease with estimated glomerular filtration rate (eGFR) <30 mL/min and/or dialysis.
24. Known allergy or intolerance to aspirin, clopidogrel, ticagrelor, prasugrel, bivalirudin, unfractionated heparin, P2Y12 antagonists, or contrast.

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: Monotherapy of MT1002, 3 doses via intravenous (IV) + infusion; Three doses of MT1002 (IV loading + continuous IV infusion) will be sequentially tested. The first dose level is 0.90 mg/kg initial loading dose (bolus intravenous injection) + 1.8 mg/kg/h (infusion) for 4 hours. The second dose level will be based on the results from the first cohort (If the dose is escalated, then the second dose level is 1.2 mg/kg initial loading dose (bolus intravenous injection) + 2.3 mg/kg/h (infusion) for 4 hours; if the dose is de-escalated, then the second dose level is 0.6 mg/kg initial loading dose (bolus intravenous injection) + 1.2 mg/kg/h (infusion) for 4 hours). The third dose will be determined based on the results from the first 2 cohorts.

Drug: MT1002 for Injection; MT1002 will be initiated as close to the start of PCI as possible. MT1002 should be initiated during diagnostics angiography when indication for PCI is confirmed, provided the PCI is indicated right after the coronary angiography. PCI can start after MT1002 initiation as soon as ACT is confirmed to be ≥ 200 sec or within 30 min after MT1002 starts, whichever occurs first. MT1002 will be administered by an intravenous injection of 0.90 mg/kg, 1.2 mg/kg, or 0.6 mg/kg (depending on the dose selected for the cohort) prior to the PCI procedure, immediately followed by an IV infusion of 1.8 mg/kg/hour, 2.3 mg/kg/hour, or 1.2 mg/kg/hour (depending on the dose selected for the cohort) until completion of the procedure. At completion of PCI, subjects will be continued on IV MT1002 for 4 hours from infusion start.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Co-Primary Composite Endpoint	Composite of: achievement of target ACT (200-300 sec) on MT1002 without switching to standard of care from the start of coronary angiography through the end of the PCI procedure (up to 4 hours of continuous infusion), and successful PCI;; occurrence of BARC Type 3-5 major bleeding events from initiation of study drug through 30 days post-PCI.	During PCI on day 1, and up to 30 days follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiovascular Events (MACE)	MACE is defined as nonfatal MI, unplanned revascularization (PCI or CABG) of the ischemic target vessel including intraprocedural stent thrombosis, re-hospitalization for a CV-related condition, nonfatal stroke, CV death, and all-cause mortality.	30 days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2020
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: January 22, 2021
• First Submitted That Met QC Criteria: January 22, 2021
• First Posted (Actual): January 25, 2021

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: ACS, PCI
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Acute Coronary Syndrome; Therapeutics; Drug Administration Routes; Drug Therapy; Injections
• Other Study ID Numbers: MT1002-II-C01

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