A Phase 2 interventional study of MT1002 for Injection in Acute Coronary Syndrome, sponsored by Shaanxi Micot Pharmaceutical Technology Co., Ltd.. Terminated at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by Shaanxi Micot Pharmaceutical Technology Co., Ltd. · Phase 2, Interventional, and Treatment
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.
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.
1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.
This study's enrollment of 6 is below the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →Shaanxi Micot Pharmaceutical Technology Co., Ltd. is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
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
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.
Co-Primary Composite Endpoint
Composite of: 1. 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; 2. occurrence of BARC Type 3-5 major bleeding events from initiation of study drug through 30 days post-PCI.
Time frame: During PCI on day 1, and up to 30 days follow up
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.
Time frame: 30 days
12 patients were screended, 6 patients were enrolled into the first dose group and dosed of MT1002 0.90mg/kg bonus+1.8mg/kg/h×4h infusion.
| Milestone | MT1002 0.90mg/kg Bonus+1.8mg/kg/h×4h Infusion |
|---|---|
| Started | 6 |
| Completed | 6 |
| Not completed | 0 |
Composite of: 1. 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; 2. occurrence of BARC Type 3-5 major bleeding events from initiation of study drug through 30 days post-PCI.
| Participants | MT1002 0.90mg/kg Bonus+1.8mg/kg/h×4h Infusion |
|---|---|
| The number of patients with target ACT (200 -300 seconds [sec]) achieved on MT1002 prior/during PCI. | 6 |
| Bleeding events major (Bleeding Academic Research Consortium [BARC] Type 3-5) | 0 |
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.
| Participants | Monotherapy of MT1002, 3 Doses Via Intravenous (IV) + Infusion |
|---|---|
| Major Adverse Cardiovascular Events (MACE) | 0 |
Collected over From enrollment until end of follow-up, which is 30 days after PCI.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MT1002 0.90mg/kg Bonus+1.8mg/kg/h×4h Infusion | 0/6 (0%) | 0/6 (0%) | 2/6 (33.3%) |
| Event | MT1002 0.90mg/kg Bonus+1.8mg/kg/h×4h Infusion |
|---|---|
| HypokalaemiaMetabolism and nutrition disorders | 1/6 |
| Blood creatinine increasedInvestigations | 1/6 |
| Troponin increasedInvestigations | 1/6 |
| NauseaGastrointestinal disorders | 1/6 |
| Chest painRespiratory, thoracic and mediastinal disorders | 1/6 |
| HyperlipidaemiaMetabolism and nutrition disorders | 1/6 |
| Blood creatine phosphokinase MB increasedInvestigations | 1/6 |
| HaematomaVascular disorders | 1/6 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 1/6 |
| Vision blurredEye disorders | 1/6 |
| Age, Continuous(Years) | MT1002 0.90mg/kg Bonus+1.8mg/kg/h×4h Infusion |
|---|---|
| Mean | 65.7 (51 to 72) |
| Sex: Female, Male(Participants) | MT1002 0.90mg/kg Bonus+1.8mg/kg/h×4h Infusion |
|---|---|
| Female | 1 |
| Male | 5 |
| Ethnicity (NIH/OMB)(Participants) | MT1002 0.90mg/kg Bonus+1.8mg/kg/h×4h Infusion |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 6 |
| Unknown or Not Reported | 0 |
| CRUSADE Bleeding Risk Score(Participants) | MT1002 0.90mg/kg Bonus+1.8mg/kg/h×4h Infusion |
|---|---|
| CRUSADE Bleeding Risk Score ≤20 | 4 |
| CRUSADE Bleeding Risk Score from 31-40 | 2 |
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Shaanxi Micot Pharmaceutical Technology Co., Ltd.