MT1002 Phase II Study in ACS Patients With PCI

NCT04723186 | Terminated Phase 2 FDA Drug

• 1 other identifier: MT1002-II-C01
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome

Keywords

ACS, PCI

Outcome Measures

Primary Outcomes (1)

• 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)

  30 days

Secondary Outcomes (3)

• Major adverse cardiovascular event(s)

  30 days

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

  30 days

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

  30 days

Study Arms (1)

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

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.

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Shaanxi Micot Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

IU Health - BMH

Muncie, Indiana, 47303, United States

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Injections

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-Label, Sequential-Dose Escalation/De-escalation Trial

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: January 25, 2021
• Study Start: December 2, 2020
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: October 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)