Expired Study
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Boston, Massachusetts 02115


Purpose:

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.


Study summary:

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.


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.


NCT ID:

NCT00099788


Primary Contact:

Principal Investigator
David A Morrow, MD
TIMI Study Group


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02115
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 14, 2017

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