MT1002 Phase II Study in ACS Patients With PCI

Status Terminated

Clinical 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04723186
Study type	Interventional
Source	Shaanxi Micot Technology Limited Company
Contact
Status	Terminated
Phase	Phase 2
Start date	December 2, 2020
Completion date	August 31, 2023

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