Status:
TERMINATED
MT1002 Phase II Study in ACS Patients With PCI
Lead Sponsor:
Shaanxi Micot Pharmaceutical Technology Co., Ltd.
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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. Three doses of MT1002 will be sequentially test...
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 a...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- .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.
Key Trial Info
Start Date :
December 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2023
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04723186
Start Date
December 2 2020
End Date
August 31 2023
Last Update
October 31 2023
Active Locations (1)
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1
IU Health - BMH
Muncie, Indiana, United States, 47303