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MT1002 Phase II Study in ACS Patients With PCI

  • Clinicaltrials.gov identifier

    NCT04723186

  • Recruitment Status

    Recruiting

  • First Posted

    January 25, 2021

  • Last update posted

    November 17, 2021

Study Description

Brief summary:

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.

  • Condition or Disease:Acute Coronary Syndrome
  • Intervention/Treatment: Drug: MT1002
  • Phase: Phase 2

Detailed Description

MT1002 is a novel bispecific peptide with properties of a direct thrombin inhibitor and a glycoprotein IIb/IIIa inhibitor. Three doses of MT1002 will be sequentially tested in cohorts of 6 patients each to achieve target ACT.

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 20 participants
  • Intervention Model: Single Group Assignment
  • Intervention Model Description: Open-Label, Sequential-Dose Escalation/De-escalation Trial
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Open-Label, Sequential-Dose Escalation/De-escalation Trial Testing MT1002 in Patients Undergoing PCI Due to Acute Coronary Syndrome With NSTEMI
  • Actual Study Start Date: December 2020
  • Estimated Primary Completion Date: May 2022
  • Estimated Study Completion Date: July 2022

Arms and interventions

Arm Intervention/treatment
Experimental: MT1002
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) via IV access 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.
Drug: MT1002
Monotherapy of MT1002, 3 doses via intravenous (IV) + infusion

Outcome Measures

  • Primary Outcome Measures: 1. To determine the safe and well tolerated dose of MT1002 in patients. [ Time Frame: 30 days ]
    General safety, including vital signs, physical examination, electrocardiogram, laboratory assessments, adverse events, MACE within 30 days, and major bleeding events.
  • Secondary Outcome Measures: 1. MACE [ Time Frame: 30 days ]
    Major adverse cardiovascular events
  • 2. To evaluate the anti-coagulation effect of MT1002 [ Time Frame: 30 days ]
    By activated partial thromboplastin time (aPTT) and activated clotting time (ACT)
  • 3. To evaluate the anti-platelet effect of MT1002 [ Time Frame: 30 days ]
    By inhibition of platelet aggregation (IPA)

Eligibility Criteria

  • Ages Eligible for Study: 18 to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria: Presenting within 24 hours from the onset of symptoms of cardiac ischemia Diagnosed with NSTEMI defined as new or presumably new ST-segment depression of at least 1 mm in 2 contiguous leads, T-wave inversion more than 3 mm, or any dynamic ST shifts, or elevated troponin I higher than upper limit of normal (ULN), T, or CK-MB consistent with the universal definition of MI, and admission within 24 hours of symptom onset Indication for early PCI as per international or local guidelines Ability to understand and willing to give written informed consent. Signed informed consent form before any study related activities. 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 (ie, documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy). Females of childbearing potential and males with partners of childbearing potential must be using effective contraception if they become sexually active from the time of consent to 90 days after the MT1002 infusion day (ie, any double combination of male or female condom with spermicidal gel, diaphragm, sponge, or cervical cap with spermicidal gel). Women who are breastfeeding are excluded. Exclusion Criteria: Cardiogenic shock or prolonged cardiopulmonary resuscitation (CPR) Active bleeding, bleeding diathesis, coagulopathy Any history of intracranial bleeding or structural abnormalities (intracerebral mass, aneurysm, arteriovenous malformation [AVM]) Prior transient ischemic attack, prior stroke within 12 months Index MI is STEMI or new left bundle branch block The following planned procedures within 30 days after enrollment: staged PCI, CABG, valve surgery, or additional invasive procedures Pre-existing atrial fibrillationand prolonged QTc (470ms in men, 480ms in women) Anticipated requirement for oral anticoagulants before Day 30 9. CRUSADE (Can Rapid risk stratification of Unstable angina patients Suppress ADverse outcomes with Early implementation of the American College of Cardiology/American Heart Association [ACC/AHA] Guidelines) bleeding risk score >40 Suspected aortic dissection History of gastrointestinal or genitourinary bleeding within the previous 3 months Refusal to receive blood transfusion if needed during the study Major surgery in the last 6 months History of heparin-induced thrombocytopenia and bleeding diathesis Severe uncontrolled hypertension, defined as a systolic blood pressure > 180 mm Hg and diastolic blood pressure > 100 mm Hg despite 1 hour of adequate treatment Prior or planned administration of thrombolytics, glycoprotein IIb/IIIa inhibitors, bivalirudin, or fondaparinux for the index MI. Subcutaneous injections of unfractionated heparin and low molecular weight heparin are allowed up to 4 hours and 8 hours, respectively, before study drug. Known relevant hematological deviations: hemoglobin (male) < 11 g/dL, hemoglobin (female) < 10 g/dL, hematocrit < 35%, platelet count < 100,000 cells/μL Use of Coumadin derivatives within the last 7 days Chronic therapy with non-steroidal anti-inflammatory drugs (NSAIDs; except aspirin), cyclooxegenase (COX)-2 inhibitors, prasugrel, ticagrelor within one month before screening Known malignancies or other comorbid conditions with life expectancy < 1 year that may result in protocol noncompliance Known severe liver disease (aspartate aminotransferase [AST], alanine aminotransferase [ALT] > 3 × ULN) Known positive serology for hepatitis B & C, HIV screen Known chronic kidney disease with glomerular filtration rate <30 mL/min and/or dialysis Known allergy or intolerance to aspirin, clopidogrel, bivalirudin, unfractionated heparin, P2Y12 antagonists, or contrast Previous enrollment in this trial Inability to fully cooperate with the study protocol Any other medical or psychiatric condition that in the Investigator's judgment precludes participation in the study

Contacts and Locations

Contacts

Contact: Ruben Zhao, MD +86 18001098786 zhaolibin@micot.cn

Contact: Sachin Ojha +61 439949954 Sachin.Ojha@premier-research.com

Locations

United States, Minnesota
Jay Traverse
Minneapolis

Sponsors and Collaborators

Shaanxi Micot Technology Limited Company

More Information

  • Responsible Party: Shaanxi Micot Technology Limited Company
  • ClinicalTrials.gov Identifier: NCT04723186 History of Changes
  • Other Study ID Numbers: MT1002-II-C01
  • First Posted: January 25, 2021 Key Record Dates
  • Last Update Posted: November 17, 2021
  • Last Verified: January 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Shaanxi Micot Technology Limited Company: ACS, PCI
  • Additional relevant MeSH terms: Acute Coronary Syndrome
    Syndrome
    Disease
    Pathologic Processes
    Myocardial Ischemia
    Heart Diseases
    Cardiovascular Diseases
    Vascular Diseases