Trial Outcomes & Findings for MT1002 Phase II Study in ACS Patients With PCI (NCT NCT04723186)

Last Updated: 2026-05-27

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

During PCI on day 1, and up to 30 days follow up

Results posted on

2026-05-27

Participant Flow

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.

Participant milestones

Participant milestones
Measure	MT1002 0.90mg/kg Bonus+1.8mg/kg/h×4h Infusion 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.
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MT1002 Phase II Study in ACS Patients With PCI

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MT1002 0.90mg/kg Bonus+1.8mg/kg/h×4h Infusion n=6 Participants 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.
Age, Continuous	65.7 Years n=51 Participants
Sex: Female, Male Female	1 Participants n=51 Participants
Sex: Female, Male Male	5 Participants n=51 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=51 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=51 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=51 Participants
CRUSADE Bleeding Risk Score CRUSADE Bleeding Risk Score ≤20	4 Participants n=51 Participants
CRUSADE Bleeding Risk Score CRUSADE Bleeding Risk Score from 31-40	2 Participants n=51 Participants

PRIMARY outcome

Timeframe: During PCI on day 1, and up to 30 days follow up

Outcome measures

Outcome measures
Measure	MT1002 0.90mg/kg Bonus+1.8mg/kg/h×4h Infusion n=6 Participants 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.
Co-Primary Composite Endpoint The number of patients with target ACT (200 -300 seconds [sec]) achieved on MT1002 prior/during PCI.	6 Participants
Co-Primary Composite Endpoint Bleeding events major (Bleeding Academic Research Consortium [BARC] Type 3-5)	0 Participants

SECONDARY outcome

Timeframe: 30 days

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.

Outcome measures

Outcome measures
Measure	MT1002 0.90mg/kg Bonus+1.8mg/kg/h×4h Infusion n=6 Participants 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.
Major Adverse Cardiovascular Events (MACE)	0 Participants

Adverse Events

MT1002 0.90mg/kg Bonus+1.8mg/kg/h×4h Infusion

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MT1002 0.90mg/kg Bonus+1.8mg/kg/h×4h Infusion n=6 participants at risk 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.
Metabolism and nutrition disorders Hypokalaemia	16.7% 1/6 • From enrollment until end of follow-up, which is 30 days after PCI.
Investigations Blood creatinine increased	16.7% 1/6 • From enrollment until end of follow-up, which is 30 days after PCI.
Investigations Troponin increased	16.7% 1/6 • From enrollment until end of follow-up, which is 30 days after PCI.
Gastrointestinal disorders Nausea	16.7% 1/6 • From enrollment until end of follow-up, which is 30 days after PCI.
Respiratory, thoracic and mediastinal disorders Chest pain	16.7% 1/6 • From enrollment until end of follow-up, which is 30 days after PCI.
Metabolism and nutrition disorders Hyperlipidaemia	16.7% 1/6 • From enrollment until end of follow-up, which is 30 days after PCI.
Investigations Blood creatine phosphokinase MB increased	16.7% 1/6 • From enrollment until end of follow-up, which is 30 days after PCI.
Vascular disorders Haematoma	16.7% 1/6 • From enrollment until end of follow-up, which is 30 days after PCI.
Respiratory, thoracic and mediastinal disorders Epistaxis	16.7% 1/6 • From enrollment until end of follow-up, which is 30 days after PCI.
Eye disorders Vision blurred	16.7% 1/6 • From enrollment until end of follow-up, which is 30 days after PCI.

Additional Information

Lin Wang

Shaanxi Micot Technology Limited Company

Phone: +86(29)89303986

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER