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MT1002 Phase II Study in ACS Patients With PCI

Primary Purpose

Acute Coronary Syndrome

Status

Suspended

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

MT1002 for Injection

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring ACS, PCI

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

.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.

Sites / Locations

IU Health - BMH

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Monotherapy of MT1002, 3 doses via intravenous (IV) + infusion

Arm Description

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.

Outcomes

Primary Outcome Measures

To determine the safe and well tolerated dose of MT1002 in patients with ACS with NSTEMI and PCI.

Co-Primary endpoints: The number of patients with target ACT (200 -300 seconds [sec]) achieved on MT1002 (no switch to standard of care) prior/during PCI and PCI success. Adverse event (AE) of interest: bleeding events major (Bleeding Academic Research Consortium [BARC] Type 3-5)

Secondary Outcome Measures

Major adverse cardiovascular event(s)

To evaluate the anti-coagulation effect of MT1002 by activated partial thromboplastin time (aPTT) and activated clotting time (ACT)

Coagulation parameters (ACT, aPTT, PT, TT, FIB, INR) and Percentage of patients who achieve ACT ≥ 200 sec

To evaluate the anti-platelet effect of MT1002 by platelet aggregation (PA)

Full Information

NCT ID

NCT04723186

First Posted

January 22, 2021

Last Updated

May 30, 2023

Sponsor

Shaanxi Micot Technology Limited Company

1. Study Identification

Unique Protocol Identification Number

NCT04723186

Brief Title

MT1002 Phase II Study in ACS Patients With PCI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Suspended

Why Stopped

Study was suspended due to strategic reasons. No safety or efficacy issues.

Study Start Date

December 2, 2020 (Actual)

Primary Completion Date

July 31, 2023 (Anticipated)

Study Completion Date

July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shaanxi Micot Technology Limited Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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. Three doses of MT1002 will be sequentially tested in cohorts of 6 patients each to achieve target ACT.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome

Keywords

ACS, PCI

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Open-Label, Sequential-Dose Escalation/De-escalation Trial

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Monotherapy of MT1002, 3 doses via intravenous (IV) + infusion

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

MT1002 for Injection

Intervention Description

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.

Primary Outcome Measure Information:

Title

To determine the safe and well tolerated dose of MT1002 in patients with ACS with NSTEMI and PCI.

Description

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Major adverse cardiovascular event(s)

Time Frame

30 days

Title

To evaluate the anti-coagulation effect of MT1002 by activated partial thromboplastin time (aPTT) and activated clotting time (ACT)

Description

Coagulation parameters (ACT, aPTT, PT, TT, FIB, INR) and Percentage of patients who achieve ACT ≥ 200 sec

Time Frame

30 days

Title

To evaluate the anti-platelet effect of MT1002 by platelet aggregation (PA)

Description

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: .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.

Facility Information:

Facility Name

IU Health - BMH

City

Muncie

State/Province

Indiana

ZIP/Postal Code

47303

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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