Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06533358
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
A Clinical Study of MT1002 in Subjects With Acute Coronary Syndrome Undergoing PCI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-label Sequential Dose EscalationDe-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:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
An Open-label Sequential Dose EscalationDe-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 IIbIIIa 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 escalationde-escalation clinical trial of MT1002 in subjects with acute coronary syndrome undergoing PCI First dose cohort is 060 mgkg initial loading dose intravenous bolus 12 mgkgh4 h maintenance dose intravenous infusion The Safety Review Committee makes decisions on subsequent dose adjustments Dose escalationde-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 escalationde-escalation clinical trial of MT1002 in subjects with acute coronary syndrome undergoing PCI First dose cohort is 060 mgkg initial loading dose intravenous bolus 12 mgkgh4 h maintenance dose intravenous infusion The Safety Review Committee makes decisions on subsequent dose adjustments Dose escalationde-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?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None