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Monotherapy of MT1002, 3 doses via intravenous (IV) + infusion for Acute Coronary Syndrome

Phase 2

Waitlist Available

Research Sponsored by Shaanxi Micot Technology Limited Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

Study Summary

This trial is testing a new drug, MT1002, to see if it can help people with a heart condition called ACS with NSTEMI.

Eligible Conditions

Acute Coronary Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To determine the safe and well tolerated dose of MT1002 in patients with ACS with NSTEMI and PCI.

Secondary outcome measures

Major adverse cardiovascular event(s)

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

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Monotherapy of MT1002, 3 doses via intravenous (IV) + infusionExperimental Treatment1 Intervention

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.

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Find a Location

Who is running the clinical trial?

Shaanxi Micot Technology Limited CompanyLead Sponsor

4 Previous Clinical Trials

132 Total Patients Enrolled

1 Trials studying Acute Coronary Syndrome

2 Patients Enrolled for Acute Coronary Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has MT1002 been cleared by the Federal Drug Administration?

"MT1002's safety is estimated to be a 2. While there is some data supporting its safety, none of it suggests that MT1002 is an effective medication."

Answered by AI

Does this clinical research include elderly participants over the age of 75?

"The age parameters for this study (18-85) disqualify anyone that is either too young or too old. Out of the 3,467 similar studies, 388 are for children and 1,089 are for senior citizens."

Answered by AI

Are there any unfilled positions in this trial for new participants?

"That is accurate. The information available on clinicaltrials.gov verifies that this study, which was originally posted on December 2nd 2020, is still looking for individuals to enroll. So far, 20 people have signed up at the 2 trial locations."

Answered by AI

How can I sign up to participate in this clinical trial?

"This trial is admitting 20 patients between the ages of 18 and 85 who have acute coronary syndrome. The following criteria must also be met: Ability to understand and give written informed consent, Diagnosed with NSTEMI, 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 use effective contraception, Patients who will undergo PCI during the index hospitalization for an NSTEMI, Males and females ≥ 18 to 85 years of age."

Answered by AI

How many people are included in this experiment?

"That is correct. The clinicaltrials.gov website says that this trial is currently looking for subjects to enroll. This particular study was posted on December 2nd 2020 and updated as recently as October 24th 2022. So far, 20 patients have been enrolled at 2 locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

MT1002 Phase II Study in ACS Patients With PCI

2020. "MT1002 Phase II Study in ACS Patients With PCI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04723186.