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

Last updated: November 24, 2009
Sponsor: Gilead Sciences
Overall Status: Completed

Phase

3

Condition

Myocardial Ischemia

Chest Pain

Atherosclerosis

Treatment

N/A

Clinical Study ID

NCT00099788
CVT 3036
MERLIN TIMI 36
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 studyentry

  • At least one additional risk factor (e.g., elevated cardiac enzymes, ST-depression,diabetes)

Exclusion

Exclusion Criteria:

  • Persistent acute ST-segment elevation

  • Successful revascularization during the qualifying hospitalization, prior to studyentry

  • 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 anacceptable form of birth control Additional study entry criteria will be evaluated during initial screening.

Study Design

Total Participants: 6560
Study Start date:
October 01, 2004
Estimated Completion Date:
February 28, 2007

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

Connect with a study center

  • The TIMI Study Group

    Boston, Massachusetts 02115
    United States

    Site Not Available

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