Ignite Creation Date:
2025-12-25 @ 5:10 AM
Ignite Modification Date:
2025-12-26 @ 4:15 AM
Study NCT ID:
NCT01000727
Status:
COMPLETED
Last Update Posted:
2017-08-10
First Post:
2009-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Stabilization Of pLaques usIng Darapladib-Thrombolysis In Myocardial Infarction 52 Trial
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
A Clinical Outcomes Study of Darapladib Versus Placebo in Subjects Following Acute Coronary Syndrome to Compare the Incidence of Major Adverse Cardiovascular Events (MACE).
Status:
COMPLETED
Status Verified Date:
2017-06
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:
SOLID-TIMI 52
Brief Summary:
This study will test whether darapladib can safely lower the chances of having a cardiovascular event (such as a heart attack or urgent coronary revascularization (e.g. medical procedures performed to restore the normal blood flow in patients with atherosclerosis)) when treatment is started within 30 days after an acute coronary syndrome (also called ACS).
Detailed Description:
Subjects who qualify for the study will be randomized 1:1 to either darapladib or placebo administered in addition to standard therapy. Following the baseline visit, subjects will be expected to return for clinic visits at 1 month, 3 months, 6 months and every 6 months until the end of the study.
Study Oversight
Has Oversight DMC:
True
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?: