Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes
NCT00099788 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6560
Last updated 2009-11-26
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 5,500 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.
Conditions
- Myocardial Ischemia
Interventions
- DRUG
-
Ranolazine
IV to oral transition.
- DRUG
-
IV to oral transition.
Sponsors & Collaborators
-
The TIMI Study Group
collaborator OTHER - lead INDUSTRY
Principal Investigators
-
David A Morrow, MD · The TIMI Study Group
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-10-31
- Primary Completion
- 2007-02-28
- Completion
- 2007-02-28
Countries
- United States
Study Locations
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