Ignite Creation Date:
2024-05-05 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00543400
Status:
COMPLETED
Last Update Posted:
2019-10-15
First Post:
2007-10-11
Brief Title:
Evaluation of M118 in Percutaneous Coronary Intervention EMINENCE
Sponsor:
Momenta Pharmaceuticals Inc
Organization:
Momenta Pharmaceuticals Inc
Study Overview
Official Title:
A Randomized Open-label Parallel Group Feasibility Study to Determine the Safety and Efficacy of M118 vs Unfractionated Heparin UFH in Subjects With Stable Coronary Artery Disease Undergoing Percutaneous Coronary Intervention PCI
Status:
COMPLETED
Status Verified Date:
2018-01
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:
EMINENCE
Brief Summary:
The primary objective is to evaluate the safety and feasibility of using M118 as an anticoagulant in the target population of subjects with stable coronary artery disease CAD undergoing percutaneous coronary intervention PCI
The secondary objectives are to evaluate the effect of M118 on procedural indices including procedure success abrupt closure post-procedure TIMI flow and catheter thrombus
Substudy Primary Objective The primary objective of the substudy is to characterize the pharmacokinetic and pharmacodynamic profile of M118 among subjects with stable coronary artery disease undergoing elective PCI
The secondary objectives are to evaluate the effect of M118 on procedural indices including procedure success abrupt closure post-procedure TIMI flow and catheter thrombus
Substudy Primary Objective The primary objective of the substudy is to characterize the pharmacokinetic and pharmacodynamic profile of M118 among subjects with stable coronary artery disease undergoing elective PCI
Detailed Description:
None
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