MT1002 Phase II Study in ACS Patients With PCI

• Status: Active, not recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shaanxi Micot Technology Limited Company

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