Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04723186
Status:
TERMINATED
Last Update Posted:
2023-10-31
First Post:
2021-01-22
Brief Title:
MT1002 Phase II Study in ACS Patients With PCI
Sponsor:
Shaanxi Micot Technology Limited Company
Organization:
Shaanxi Micot Technology Limited Company
Study Overview
Official Title:
Open-Label Sequential-Dose EscalationDe-escalation Trial Testing MT1002 in Patients Undergoing PCI Due to Acute Coronary Syndrome With NSTEMI
Status:
TERMINATED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was decided to be terminated due to commercial considerationsnot the safety issues of the product
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label sequential-dose escalationde-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 IIbIIIa 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 escalationde-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
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 escalationde-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None