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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

A Clinical Study of MT1002 in Subjects With Acute Coronary Syndrome Undergoing PCI

An Open-label, Sequential Dose Escalation/De-escalation Clinical Trial of MT1002 in Subjects With Acute Coronary Syndrome Undergoing PCI

A Clinical Study of MT1002 in Subjects With Acute Coronary Syndrome Undergoing PCI (NCT06533358) is a Phase 2 interventional studying Acute Coronary Syndrome, sponsored by Shaanxi Micot Pharmaceutical Technology Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

An Open-label, Sequential Dose Escalation/De-escalation Clinical Trial of MT1002 in Subjects With Acute Coronary Syndrome Undergoing PCI.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Acute Coronary Syndrome and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 20 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Male and female aged 18-85 years old (both 18 and 85 years old) 2. Diagnosis of acute coronary syndrome (ACS) 3. Subjects who will undergo PCI during hospitalization 4. Able to understand and willing to sign written willing to sign a consent form prior to undertaking any study-related activities 5. Females of childbearing potential must have a negative pregnancy test result prior to enrollment or be postmenopausal for at least 1 year, or permanently sterilized for ≥ 6 weeks. For women of childbearing potential and men with female partners of childbearing potential, effective contraception must be used if they are sexually active from the time of willing to sign a consent form until 90 days after MT1002 administration Who Should NOT Join This Trial: 1. cardiogenic shock, or cardiopulmonary resuscitation (CPR) 2. Suspicious aortic dissection, pericarditis, endocarditis 3. Has any history of intracranial hemorrhage or structural abnormalities 4. Transient ischemic attack, stroke within 6 months 5. History of gastrointestinal or genitourinary bleeding within 1 month 6. Major surgery within 1 month 7. The following surgeries are planned within 1 month of enrollment: CABG, valve surgery, or other invasive procedures 8. Long-term treatment with non-steroidal anti-inflammatory drugs (except aspirin), cyclooxygenase (COX)-2 inhibitors, within 1 month prior to screening 9. Prior (within 7 days prior to enrollment) or planned use of thrombolytic agents, bivalirudin, or fondaparinux. 12 hours before enrollment, unfractionated heparin or low molecular weight heparin was injected subcutaneously. 10. Use of coumarin derivatives and/or factor Xa inhibitors in the past 7 days 11. Anticipated need for oral anticoagulants within 3 days of dosing 12. Severe uncontrolled hypertension persists even within 24 hours of adequate treatment ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Male and female aged 18-85 years old (both 18 and 85 years old) 2. Diagnosis of acute coronary syndrome (ACS) 3. Subjects who will undergo PCI during hospitalization 4. Able to understand and willing to sign written informed consent prior to undertaking any study-related activities 5. Females of childbearing potential must have a negative pregnancy test result prior to enrollment or be postmenopausal for at least 1 year, or permanently sterilized for ≥ 6 weeks. For women of childbearing potential and men with female partners of childbearing potential, effective contraception must be used if they are sexually active from the time of informed consent until 90 days after MT1002 administration Exclusion Criteria: 1. cardiogenic shock, or cardiopulmonary resuscitation (CPR) 2. Suspicious aortic dissection, pericarditis, endocarditis 3. Has any history of intracranial hemorrhage or structural abnormalities 4. Transient ischemic attack, stroke within 6 months 5. History of gastrointestinal or genitourinary bleeding within 1 month 6. Major surgery within 1 month 7. The following surgeries are planned within 1 month of enrollment: CABG, valve surgery, or other invasive procedures 8. Long-term treatment with non-steroidal anti-inflammatory drugs (except aspirin), cyclooxygenase (COX)-2 inhibitors, within 1 month prior to screening 9. Prior (within 7 days prior to enrollment) or planned use of thrombolytic agents, bivalirudin, or fondaparinux. 12 hours before enrollment, unfractionated heparin or low molecular weight heparin was injected subcutaneously. 10. Use of coumarin derivatives and/or factor Xa inhibitors in the past 7 days 11. Anticipated need for oral anticoagulants within 3 days of dosing 12. Severe uncontrolled hypertension persists even within 24 hours of adequate treatment 13. According to the judgment of the investigator, the subject has a high risk of bleeding, such as active bleeding, bleeding tendency, coagulation disorders, etc 14. Known associated hematologic abnormalities 15. Known to have a malignancy or comorbid other disease that may lead to protocol non-adherence with a life expectancy of \< 1 year 16. Known severe liver disease 17. Known hepatitis B and hepatitis C, HIV screening serology positive, except for the low viral replication phase. 18. Known chronic kidney disease 19. Known allergy or intolerance to aspirin, clopidogrel, ticagrelor, prasugrel, bivalirudin, unfractionated heparin, P2Y12 antagonists, or contrast agents. 20. Weight: male subjects should not be less than 50.0kg, female subjects should not be less than 45.0kg, and body mass index within the range of 18.0\~30.0kg/m2 (including boundary values) 21. Subjects who have previously used MT1002. 22. Unable to fully cooperate with the study protocol. 23. Has any other medical or psychiatric illness that, in the opinion of the investigator, precludes participation in the study.

Treatments Being Tested

DRUG

MT1002 Injection

MT1002 is infused once only, once for 4h. MT1002 is for subjects with acute coronary syndrome undergoing PCI

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Beijing Anzhen Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Xianyang Hospital, Yan'an University
Xi'an, Shaanxi, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06533358), the sponsor (Shaanxi Micot Pharmaceutical Technology Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06533358 clinical trial studying?

An Open-label, Sequential Dose Escalation/De-escalation Clinical Trial of MT1002 in Subjects With Acute Coronary Syndrome Undergoing PCI. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06533358?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06533358?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06533358. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06533358. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.