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

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Collaborator: The TIMI Study Group
• Treatments: Ranolazine

Criteria

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.