Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00099788
Status:
COMPLETED
Last Update Posted:
2009-11-26
First Post:
2004-12-21
Brief Title:
Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
A Randomized Double-blind Parallel-group Placebo-controlled Multinational Clinical Trial to Evaluate the Efficacy and Safety of Ranolazine vs Placebo in Patients With Non-ST Segment Elevation Acute Coronary Syndromes
Status:
COMPLETED
Status Verified Date:
2009-11
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:
MERLIN-TIMI 36 is a multi-national double-blind randomized placebo-controlled parallel-group clinical trial designed to evaluate the efficacy and safety of ranolazine during acute and long-term treatment in approximately 5500 patients with non-ST elevation acute coronary syndromes ACS treated with standard therapy The primary efficacy endpoint in MERLIN-TIMI 36 is time to first occurrence of any element of the composite of cardiovascular death myocardial infarction or recurrent ischemia in patients with non-ST elevation ACS receiving standard therapy The study also evaluates the safety of long-term treatment with ranolazine compared to placebo
Detailed Description:
Morrow DA Scirica BM Karwatowska-Prokopczuk E Skene A McCabe CH Braunwald E MERLIN-TIMI 36 Investigators Evaluation of a novel anti-ischemic agent in acute coronary syndromes design and rationale for the Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST-elevation acute coronary syndromes MERLIN-TIMI 36 trial Am Heart J 2006 Jun15161186e1-9
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MERLIN TIMI 36 | None | None | None |