Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes

Study Overview
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Brief Summary
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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.

Detailed Description
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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 Jun;151(6):1186.e1-9.

Official Title
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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

Conditions
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Myocardial Ischemia

Intervention / Treatment
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* Drug: Ranolazine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalized with non-ST elevation acute coronary syndrome Ischemic symptoms (more than or equal to 5 minutes) at rest within 48 hours of study entry At least one additional risk factor (e.g., elevated cardiac enzymes, ST-depression, diabetes) Exclusion Criteria: Persistent acute ST-segment elevation Successful revascularization during the qualifying hospitalization, prior to study entry Acute pulmonary edema, hypotension, or evidence of cardiogenic shock Clinically significant liver disease End stage kidney disease requiring dialysis Concomitant use of drugs known to prolong the QT interval, or any digitalis drugs Use at study entry of drugs that are strong inhibitors of cytochrome P450 3A4 Pregnant or lactating women, or women of child bearing potential not using an acceptable form of birth control Additional study entry criteria will be evaluated during initial screening.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Ranolazine | Drug: Ranolazine<br>* IV to oral transition.<br>* Other names: Ranexa;|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* IV to oral transition.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first occurrence of any element of the composite of cardiovascular death, myocardial infarction or recurrent ischemia through the end of the follow-up in non-ST elevation ACS. |  | First occurrence | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of cardiovascular death, myocardial infarction, or severe recurrent ischemia. Safety of long-term treatment with ranolazine compared to placebo; safety endpoints are death from any cause and symptomatic documented arrhythmia. |  | First occurence | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Angina, Acute Coronary Syndrome, Myocardial Infarction, Heart Attack, Chest pain, Ischemia, Non-ST Elevation Acute Coronary Syndrome