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

Completed · Phase 3 · Has a placebo group

Conditions studied: Myocardial Ischemia

In brief

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.

Key facts

Study ID

NCT00099788

Run by

Gilead Sciences

People needed

6560

Starts

2004-10-01

Expected to finish

2007-02-01

Last updated by the study team

2009-11-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• The TIMI Study Group — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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