Acute Coronary SyndromePhase 2NCT04723186
MT1002 Phase II Study in ACS Patients With PCI
A Phase 2 study testing MT1002 for Injection in people with Acute Coronary Syndrome, run by Shaanxi Micot Pharmaceutical Technology Co., Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- MT1002 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2020to 31 Aug 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- .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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-Label, Sequential-Dose Escalation/De-escalation Trial Testing MT1002 in Patients Undergoing PCI Due to Acute Coronary Syndrome With NSTEMI
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.
Read the 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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- MT1002 for Injection
- Keywords
- ACS, PCI
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT1002 for InjectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: MT1002 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During PCI on day 1, and up to 30 days follow up
Secondary outcomes (1)
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start2 Dec 2020
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Why it stopped: The study was decided to be terminated due to commercial considerations,（not the safety issues of the product）.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-Label, Sequential-Dose Escalation/De-escalation Trial
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaanxi Micot Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723186
- Sponsor's protocol ID
- MT1002-II-C01
- Status last verified
- Apr 2026
- First submitted
- 22 Jan 2021
- Last updated
- 27 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Sequential-Dose Escalation/De-escalation Trial Testing MT1002 in Patients Undergoing PCI Due to Acute Coronary Syndrome With NSTEMI
- ClinicalTrials.gov ID
- NCT04723186
- Acronym / sponsor ID
- MT1002-II-C01
- Conditions
- Acute Coronary Syndrome
- Keywords
- ACS, PCI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was decided to be terminated due to commercial considerations,（not the safety issues of the product）.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Shaanxi Micot Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 25 Jan 2021 (actual)
- Results
- Posted 27 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-Label, Sequential-Dose Escalation/De-escalation Trial
| Arm | Type | Receives |
|---|---|---|
| Monotherapy of MT1002, 3 doses via intravenous (IV) + infusion | Experimental | Drug: MT1002 for InjectionThree 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (24 listed)
- .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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MT1002 for InjectionMT1002 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. | Drug | Monotherapy of MT1002, 3 doses via intravenous (IV) + infusion |
Primary outcome
Co-Primary Composite Endpoint
Time frame: During PCI on day 1, and up to 30 days follow up
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.
1 secondary outcome
Major Adverse Cardiovascular Events (MACE)
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MT1002 for Injection in people with Acute Coronary Syndrome, run by Shaanxi Micot Pharmaceutical Technology Co., Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Co-Primary Composite Endpoint (time frame: During PCI on day 1, and up to 30 days follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.