MT1002 Phase II Study in ACS Patients With PCI | NCT04723186

NCT04723186

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Monotherapy of MT1002, 3 doses via intravenous (IV) + infusion	Experimental	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.	Drug: MT1002 for Injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MT1002 for Injection	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Co-Primary Composite Endpoint	Composite of: achievement of target ACT (200-300 sec) on MT1002 without switching to standard of care from the start of coronary angiography through the end of the PCI procedure (up to 4 hours of continuous infusion), and successful PCI; occurrence of BARC Type 3-5 major bleeding events from initiation of study drug through 30 days post-PCI.	During PCI on day 1, and up to 30 days follow up

Secondary Outcomes

Measure	Description	Time Frame
Major Adverse Cardiovascular Events (MACE)	MACE is defined as nonfatal MI, unplanned revascularization (PCI or CABG) of the ischemic target vessel including intraprocedural stent thrombosis, re-hospitalization for a CV-related condition, nonfatal stroke, CV death, and all-cause mortality.	30 days

Eligibility Module

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	Status	City	State	ZIP	Country	Contacts
IU Health - BMH		Muncie	Indiana	47303	United States

Arm/Group Information

ID	Title	Description
FG000	MT1002 0.90mg/kg Bonus+1.8mg/kg/h×4h Infusion	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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	MT1002 0.90mg/kg Bonus+1.8mg/kg/h×4h Infusion	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.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Co-Primary Composite Endpoint

Composite of:

achievement of target ACT (200-300 sec) on MT1002 without switching to standard of care from the start of coronary angiography through the end of the PCI procedure (up to 4 hours of continuous infusion), and successful PCI;
occurrence of BARC Type 3-5 major bleeding events from initiation of study drug through 30 days post-PCI.

Posted

Count of Participants

Participants

During PCI on day 1, and up to 30 days follow up

ID	Title	Description
OG000	MT1002 0.90mg/kg Bonus+1.8mg/kg/h×4h Infusion	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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	MT1002 0.90mg/kg Bonus+1.8mg/kg/h×4h Infusion	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.

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

ID	Term
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics