Ignite Creation Date:
2024-05-06 @ 2:52 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02145468
Status:
COMPLETED
Last Update Posted:
2017-06-02
First Post:
2014-05-15
Brief Title:
A Phase 3 Clinical Outcomes Study to Compare the Incidence of Major Adverse Cardiovascular Events in Subjects Presenting With Acute Coronary Syndrome Treated With Losmapimod Compared to Placebo LATITUDE-TIMI 60
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Clinical Outcomes Study to Compare the Incidence of Major Adverse Cardiovascular Events in Subjects Presenting With Acute Coronary Syndrome Treated With Losmapimod Compared to Placebo PM1116197 LosmApimod To Inhibit p38 MAP Kinase as a TherapeUtic Target and moDify Outcomes After an Acute Coronary syndromE LATITUDE-TIMI 60
Status:
COMPLETED
Status Verified Date:
2017-03
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:
LATITUDE
Brief Summary:
Losmapimod is a new anti-inflammatory medication which potentially may benefit patients with Acute Coronary Syndrome ACS a condition which includes heart attack There is a growing understanding that the inflammatory response to ACS is integral to the subsequent evolution of plaque instability Losmapimod inhibits p38 mitogen activated protein kinase MAPK an enzyme which may play a central role in inflammation in the setting of heart attack Inhibition of p38 MAPK may stabilize atherosclerotic plaques reduce the risk of subsequent plaque rupture indirectly improve vascular function and prevent subsequent thrombosis and thus reduce infarct size and the risk of subsequent cardiac events This study will test whether losmapimod can safely reduce the risk of a subsequent cardiovascular event such as death heart attack or near heart attack requiring urgent treatment when started immediately after ACS specifically heart attack Patients who present with heart attack and qualify for the study will be randomly assigned to receive 3 months treatment with either losmapimod twice daily or placebo which will be administered in addition to the usual standard of care therapies for heart attack Following the in-hospital period subjects will return for outpatient visits at 4 and 12 weeks as well as a follow up visit at 24 weeks
Detailed Description:
None
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