Ignite Creation Date:
2025-12-25 @ 12:15 AM
Ignite Modification Date:
2026-01-18 @ 7:24 PM
Study NCT ID:
NCT06533358
Status:
RECRUITING
Last Update Posted:
2024-08-01
First Post:
2024-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study of MT1002 in Subjects With Acute Coronary Syndrome Undergoing PCI
Sponsor:
Shaanxi Micot Pharmaceutical Technology Co., Ltd.
Organization:
Study Overview
Official Title:
An Open-label, Sequential Dose Escalation/De-escalation Clinical Trial of MT1002 in Subjects With Acute Coronary Syndrome Undergoing PCI
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
An Open-label, Sequential Dose Escalation/De-escalation Clinical Trial of MT1002 in Subjects With Acute Coronary Syndrome Undergoing PCI.
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 IIb/IIIa receptor antagonist, indicated for use as an antithrombotic and anticoagulant in patients with ACS and in patients undergoing PCI.
This study is an Open-label, sequential dose escalation/de-escalation clinical trial of MT1002 in subjects with acute coronary syndrome undergoing PCI. First dose cohort is 0.60 mg/kg (initial loading dose, intravenous bolus) + 1.2 mg/kg/h\*4 h (maintenance dose, intravenous infusion). The Safety Review Committee makes decisions on subsequent dose adjustments. Dose escalation/de-escalation and stopping rules have been put in place to ensure the safety of the patients in this study.
This study is an Open-label, sequential dose escalation/de-escalation clinical trial of MT1002 in subjects with acute coronary syndrome undergoing PCI. First dose cohort is 0.60 mg/kg (initial loading dose, intravenous bolus) + 1.2 mg/kg/h\*4 h (maintenance dose, intravenous infusion). The Safety Review Committee makes decisions on subsequent dose adjustments. Dose escalation/de-escalation and stopping rules have been put in place to ensure the safety of the patients in this study.
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?: