MT1002 Phase II Study in ACS Patients With PCI

Stopped early · Phase 2

Conditions studied: Acute Coronary Syndrome

In brief

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.

Key facts

Study ID

NCT04723186

Run by

Shaanxi Micot Pharmaceutical Technology Co., Ltd.

People needed

6

Starts

2020-12-02

Expected to finish

2023-08-31

Last updated by the study team

2026-05-27

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females ≥ 18 to 85 years of age.
• Diagnosed with NSTEMI.
• Patients who will undergo PCI during the index hospitalization for an NSTEMI.
• Ability to understand and willing to give written informed consent.
• 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.

You may not qualify if…

• .Cardiogenic shock or prolonged cardiopulmonary resuscitation (CPR).
• Active bleeding, bleeding diathesis, coagulopathy.
• Any history of intracranial bleeding or structural abnormalities.
• Prior transient ischemic attack, prior stroke within 6 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 fibrillation or prolonged QTcF (470ms in men, 480ms in women).
• Anticipated requirement for oral anticoagulants before Day 30.
• CRUSADE 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 month.
• History of heparin-induced thrombocytopenia and bleeding diathesis.
• Severe uncontrolled hypertension.
• Prior (within 30 days prior to enrollment) or planned administration of thrombolytics, glycoprotein IIb/IIIa inhibitors, bivalirudin, or fondaparinux for the index MI.
• 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 and/or Factor Xa inhibitor drugs within the last 7 days.
• Chronic therapy with non-steroidal anti-inflammatory drugs (NSAIDs; except aspirin) , cyclooxygenase (COX)-2 inhibitors within 1 month before screening.
• Known malignancies or other comorbid conditions with life expectancy < 1 year.
• Known severe liver disease (i.e., aspartate aminotransferase [AST], alanine aminotransferase [ALT] > 3 × ULN).
• Known positive serology for hepatitis B \& C, HIV screen.
• Known chronic kidney disease with estimated glomerular filtration rate (eGFR) <30 mL/min and/or dialysis.
• Known allergy or intolerance to aspirin, clopidogrel, ticagrelor, prasugrel, bivalirudin, unfractionated heparin, P2Y12 antagonists, or contrast.

Where it is running

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

Full record on ClinicalTrials.gov

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